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SMi is proud to present the 12th Annual Pre-Filled Syringes and Injectable Drug Devices Conference in London on 15th and 16th January 2020.

As Europe’s leading PFS conference and given the key factors driving the market, we will assess advancements in design controls and applications for injectable products, enhancement of  the user interface and human factors, and optimisation of formulation and containment interaction considerations.

The rapid expansion of the PFS market and the regulatory environment are more important than ever, this year’s programme will also take a look at the EU MDR, Article 117, ISO change management standard as well as insights into the MDR post-market safety report, providing a holistic review of the Pre-Filled Syringes industry.

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.

We look forward to welcoming you to the conference in January.

This is our most sought-after event and will be sold out soon.
Early registration is strongly advised to avoid disappointment.

 

  • EXPLORE design controls, life cycle management and risk management strategies for PFS
  • UNDERSTAND the current regulatory environment with presentations from leading advisors and the MHRA, and a panel discussion on the EU MDR and Brexit
  • DELVE into formulation and container interaction considerations and best practices
  • LEARN from industry experts in an interactive pre-conference workshop day; tackling quality management systems and technical standards, testing requirements of Pre-Filled Syringes, and extractables and leachables considerations for PFS platforms
  • New for the 2020 agenda: BD | West Pharmaceutical Services | Ypsomed | Bayer | Transcoject | Ipsen | Teva | Abbott | AstraZeneca and many  more...

We keep networking at the forefront when it comes to our attendees. Expand your community, benefit from the right people and secure future collaborations.

 

• Drug-delivery developers
• Medical Device Engineers
• Primary Packaging material designers
• Secondary packagers
• Smart device developers
• Training device developers
• Device-safety solution providers
• Drug developers
• Previous attendees include:
 

3P Innovation Ltd; Accord Healthcare; Advio Associates; ANTEV Limited; Aspen Pharmacare; AstraZeneca; Barts Health NHS Trust; Barts Health Pharmaceutics; Bayer AG; BD; BD Medical - Pharmaceutical Systems; Biocompatibles Uk Ltd; Biogen Idec; Boehringer Ingelheim Pharma GmbH & Co. KG; Clexio Biosciences; Datwyler Pharma Packaging International NV; Eveon; FRUH VERPACKUNGSTECHNIK AG; GlaxoSmithKline; GSK; GSK R&D; Harro Hofliger Packaging Systems Ltd; Harro Hofliger Verpackungsmaschinen GmbH; Harrow Hofiger; Horizon Pharma; Industrias Farmaceuticas Almirall S.L; LGC; Marketing; Medicines & Healthcare products Regulatory Agency (MHRA); MedImmune; Merck; Mikron S A Boudry; Mikron SA Boudry; Mitsubishi Gas Chemical Company, INC; Mitsui Chemicals GmbH; Mitsui Chemicals, Inc.; Nelson Labs NV; Nemera; Nipro Europe NV; Novartis; Novartis A G; Novartis International AG; Novo Nordisk A/S; Owen Mumford; Owen Mumford Ltd; Panasonic Healthcare Co., Ltd.; PHC Corporation; ProQR Therapeutics; Richter Gedeon Plc; Roche; Roche Holding; Roechling; Safepoint; Sanofi; SCHOTT Pharmceutical Systems; Sio2 Medical Products; Swiss Fillow AU; Terumo Europe; Terumo Europe NV; Teva Pharmaceuticals; Teva Pharmaceuticals USA; Ultrapolymers; Vetter Pharma International GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; W.L. Gore & Associates, Inc.; Zeon Europe GmbH; ZwickRoell GmbH & Co.KG; ZwickRoell Ltd;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

James Mellman

James Mellman, Device Manager, Novartis A G
View Bio

Anil-Kumar Busimi

Anil-Kumar Busimi, Strategy and Innovation, Senior Global Product Manager, iQ Platform, SCHOTT Pharmaceutical Systems
View Bio

9:10 Reviewing the current environment in injectable drug delivery

James Mellman

James Mellman, Device Manager, Novartis A G
View Bio

  • An industry outlook into recent developments drug delivery platforms
  • How has developments in regulatory guidance effected the current drug delivery environment
  • New opportunities in drug products and what can we learn from the past year
     
  • 9:40 Design Controls for Combination Products

    Torsten Kneuss

    Torsten Kneuss, Quality Assurance Manager Combination Products, Bayer Pharma
    View Bio

  • Application of Design Controls to Combination Products – A global perspective
  • Introduction to Design Controls for Combination Products
  • Challenges with Design Controls for Combination Products
     
  • 10:10 Pre-Fillable Syringes using ZEONEX® 790R – A Case Study 10 ml / 20 ml

  • Introduction and Objective of the study
  • ZEONEX®/ZEONOR® Cyclo Olefin Polymers (COP) – recommended polymers for high end PFS
  • PFS for universal hand-held and power injector use: Design and Requirements
  • Verification testing of product functions for empty and filled containers after accelerated aging
     
  • Reinhard Scheller

    Reinhard Scheller, Commercial Manager COP Europe, Zeon Europe GmbH
    View Bio

    Jochen Heinz

    Jochen Heinz, Director New Products and Technology, Transcoject GmbH
    View Bio

    10:50 Morning Coffee

    11:20 A User Centered Portfolio Approach for Pharmaceutical Delivery Systems

    Cedric Gysel

    Cedric Gysel, Healthcare Solutions Manager, Johnson & Johnson
    View Bio

  • A Sustainable User Centered Portfolio Approach
  • Driving outcomes and better adherence by focusing on the use experience
  • Case studies
  • 11:50 Syringe integration for use with an Autoinjector

  • Auto-injectors are increasingly used for self-injection therapies for improving user’s convenience and enhancing patient’s compliance, in particular in use with bio therapeutics.
  • Functional interface of the pre-filled syringe and the application system is essential. The presentation will address specific performance features achieved with a PFS system for application with an auto-injector.
  • The joint presentation provides for information on assessing this pre-filled syringe by the application system provider
  • Nicolas Eon

    Nicolas Eon, Senior Global Product Manager, SCHOTT Pharmaceutical Systems
    View Bio

    Orfeo Niedermann

    Orfeo Niedermann, Business Development Director, Ypsomed
    View Bio

    12:30 Pre-clinical safety considerations for a drug device combination product for injection

    Clemens Guenther

    Clemens Guenther, Director Nonclinical Safety Consumer Care, Bayer
    View Bio

  • Drug related aspects
  • Formulation related aspects
  • Device related aspects: Biocompatibility assessment
  • Other components to be evaluated: Impurities, Extractables & Leachables
     
  • 13:00 Networking Lunch

    14:00 Advantages of proactive design space understanding through in-silico modelling and targeted testing

    Matthew Nicolas

    Matthew Nicolas, Investigator, GlaxoSmithKline

  • Proactive approaches to design space understanding
  • Advantages of a modelling-based approach
  • Practical examples
  • Business advantages
     
  • 14:30 Pain perception and injection devices: could pain be assessed through non-human person trials in early stage device development?

    Severine Duband

    Severine Duband, Global Category Manager, Nemera
    View Bio

  • Pain perception during injection: what are the key drivers
  • Could a study on non-human primate evaluate the pain sensitivity associated to an injection?
  • Conclusion
     
  • 15:10 Human Factors Engineering for Medical Device Development

    Remy Vomscheid

    Remy Vomscheid, Director, Devices Development & Technologies, IPSEN Pharmsciences
    View Bio

  • Human Factors Engineering: overview & regulatory framework
  • Patient-centricity in Device Design & Development
  • Case study: New Delivery System for Somatuline® Autogel®
     
  • 15:40 Afternoon Tea

    16:10 Friction and Fracture: how science can improve patients’ quality life

    Cinzia Rotella

    Cinzia Rotella, Senior Materials Scientist, Sanofi
    View Bio

  • Identify areas where scientific gaps prevent sound design engineering of DDC.
  • Case studies on using fundamental science to
  • Rigorously Define system requirements
  • Determine the appropriate control plans for robust manufacturing of DDC (PFS, Autoinjector, pen, …)
  • 16:40 The route to patient centric drug delivery

    Olaf Lebau

    Olaf Lebau, Design Engineer for Medical Devices and Combination Products, Boehringer Ingelheim GmbH
    View Bio

  • Patient considerations and pharmaceutical connectivity limitations
  • Cost vs. Adherence, where do the benefits lie?
  • Connectivity, AR and AI – new approaches to patient – drug interaction
  • Realistic patient experience approach
     
  • 17:10 Human Factors Validation of Prefilled Syringes: Lessons Learned

    Colin Roscoe

    Colin Roscoe, Principal Human Factors Scientist, Teva Pharmaceuticals
    View Bio

  • Ducks in a Row: What you need before Human Factors Validation
  • Where Eagles Dare’: Conducting Human Factors Validation
  • Having Kittens: What to do with use errors?
  • From the Horse’s mouth: HF Summary Report
     
  • 17:40 Chairs’ Closing Remarks and Close of Day One

    James Mellman

    James Mellman, Device Manager, Novartis A G
    View Bio

    Anil-Kumar Busimi

    Anil-Kumar Busimi, Strategy and Innovation, Senior Global Product Manager, iQ Platform, SCHOTT Pharmaceutical Systems
    View Bio

    18:30 End of Day One Networking Dinner - Invitation Only

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    James Mellman

    James Mellman, Device Manager, Novartis A G
    View Bio

    Anil-Kumar Busimi

    Anil-Kumar Busimi, Strategy and Innovation, Senior Global Product Manager, iQ Platform, SCHOTT Pharmaceutical Systems
    View Bio

    9:10 The new ISO change management standard

    Amanda Matthews

    Amanda Matthews, Senior Director, Pfizer UK Limited
    View Bio

    • What’s new and how what is the impact for industry?
    • The key messages of managing change through the product lifecycle
    • Consideration of the standard to ensure effective change management
     

    9:40 The MDR post-marketing safety report

    Khaudeja Bano

    Khaudeja Bano, Head of Medical Devices, Abbott Molecular Inc
    View Bio

  • FDA has pushed out their post-market reporting for the second year in a row – how has it changed and what does industry need to be aware of?
  • How does FDA review and regulate combination products?
  • How can industry adapt to the global divergence of reporting in the marketplace?
  • Considerations for PMSR compliance and drug/device application
     
  • 10:10 Regulatory focus on device-components within the new European framework

    Alison Bascou

    Alison Bascou, Senior Manager Regulatory Affairs, Beckton Dickinson (BD)
    View Bio

  • An industry’s view on EU MDR impact on combination products
  • What’s new in the Global Safety and Performance Requirements
  • New submissions and substantial changes

     

  • 10:50 Morning Coffee

    11:20 A regulatory perspective of Combinations products in the European market

    Marion Westwood

    Marion Westwood, Pharmaceutical Assesor, Medicines & Healthcare products Regulatory Agency (MHRA)
    View Bio

  • An overview of the current requirements effective PFS and combination products
  • Updates in the EU MDR and what will be expected from industry
  • How will this effect products currently on the market?
  • An outlook to the future regulatory environment for pre-filled syringes
     
  • 11:50 Panel Discussion: The EU MDR and Brexit - How can we prepare for the regulatory impact on devices

  • The current regulatory framework in the EU and UK
  • How can industry prepare for the regulatory environment post-Brexit
  • How software in conjunction with medical devices be affected
     
  • Khaudeja Bano

    Khaudeja Bano, Head of Medical Devices, Abbott Molecular Inc
    View Bio

    Amanda Matthews

    Amanda Matthews, Senior Director, Pfizer UK Limited
    View Bio

    Torsten Kneuss

    Torsten Kneuss, Quality Assurance Manager Combination Products, Bayer Pharma
    View Bio

    James Mellman

    James Mellman, Device Manager, Novartis A G
    View Bio

    12:20 How unmet market needs drive new packaging solutions for improved drug delivery

  • What are the market trends and unmet needs in primary packaging?
  • What are the latest developments in primary packaging?
  • How does new packaging can help to improve drug delivery and increase value for pharma and patients?

     

  • Christa Jansen-Otten

    Christa Jansen-Otten, Director Global Product Management, Prefilled Systems & Delivery, West Pharmaceutical Services
    View Bio

    Nicolas Brandes

    Nicolas Brandes, Director Global Product Management Polymer Prefilled Systems and Vial Containment, West Pharmaceutical Services
    View Bio

    13:00 Change is the only constant: Managing change through the lifecycle of Combination products

    Abha Raveau-Violette

    Abha Raveau-Violette, Device Manager, AstraZeneca
    View Bio

  • Reasons for changes: Why change something that works?
  • Regulatory expectations
  • Managing changes through Design Controls
  • Legacy products and changing regulatory landscape
  • Opportunities and challenges
  • 13:30 Networking Lunch

    14:30 Latest Date of OXYCAPT Multilayer Plastic Vial & Syringe

    Hiroki  Hasegawa

    Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc
    View Bio

  • Comparison among OXYCAPT, COP and Glass
  • Excellent Oxygen & Ultraviolet Barrier
  • Oxidation and Aggregation Studies of Antibody
  • Development of Staked Needle Syringe
  • 15:10 Risk Management for Combination Products

    Torsten Kneuss

    Torsten Kneuss, Quality Assurance Manager Combination Products, Bayer Pharma
    View Bio

  • Introduction to Risk Management for Combination Products
  • Typical pitfalls in the Risk Management for Combination Products
  • Upcoming changes with ISO 14971:2019
     
  • 15:40 The journey of revealing unknowns and impurities by material knowledge (The origin of species)

    Lise Vanderkelen

    Lise Vanderkelen, Department Head, Nelson Labs NV
    View Bio

  • Material characterization
  • Controlling the unknowns
  • Identifying impurities
  • Case studies
     
  • 16:20 Afternoon Tea

    16:50 Pre-Filled Syringes: A Case Study

    Benjamin Werner

    Benjamin Werner, Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG
    View Bio

  • Container closure systems – challenges and considerations
  • Syringe siliconization
  • Container closure integrity testing
     
  • 17:20 Clogging in staked-in needle pre-filled syringes

    Kewei Yang

    Kewei Yang, Pharmaceutical Scientist, Roche
    View Bio

  • Clarifying the clogging phenomenon of SIN-PFS
  • Understanding the influence of water vapor transmission through a needle shield
  • A non-invasive investigation by neutron imaging confirming that liquid can migrate into the needle
     
  • 17:50 Chairs' Closing Remarks and Close of Day Two

    James Mellman

    James Mellman, Device Manager, Novartis A G
    View Bio

    Anil-Kumar Busimi

    Anil-Kumar Busimi, Strategy and Innovation, Senior Global Product Manager, iQ Platform, SCHOTT Pharmaceutical Systems
    View Bio

    +

    FEATURED SPEAKERS

    Abha Raveau-Violette

    Abha Raveau-Violette

    Device Manager, AstraZeneca
    Alison Bascou

    Alison Bascou

    Senior Manager Regulatory Affairs, Beckton Dickinson (BD)
    Amanda Matthews

    Amanda Matthews

    Senior Director, Pfizer UK Limited
    Anil-Kumar Busimi

    Anil-Kumar Busimi

    Strategy and Innovation, Senior Global Product Manager, iQ Platform, SCHOTT Pharmaceutical Systems
    Benjamin Werner

    Benjamin Werner

    Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG
    Cedric Gysel

    Cedric Gysel

    Healthcare Solutions Manager, Johnson & Johnson
    Christa Jansen-Otten

    Christa Jansen-Otten

    Director Global Product Management, Prefilled Systems & Delivery, West Pharmaceutical Services
    Cinzia Rotella

    Cinzia Rotella

    Senior Materials Scientist, Sanofi
    Clemens Guenther

    Clemens Guenther

    Director Nonclinical Safety Consumer Care, Bayer
    Colin Roscoe

    Colin Roscoe

    Principal Human Factors Scientist, Teva Pharmaceuticals
    Hiroki  Hasegawa

    Hiroki Hasegawa

    Researcher, Mitsubishi Gas Chemical Company, Inc
    James Mellman

    James Mellman

    Device Manager, Novartis A G
    Jochen Heinz

    Jochen Heinz

    Director New Products and Technology, Transcoject GmbH
    Kewei Yang

    Kewei Yang

    Pharmaceutical Scientist, Roche
    Khaudeja Bano

    Khaudeja Bano

    Head of Medical Devices, Abbott Molecular Inc
    Marion Westwood

    Marion Westwood

    Pharmaceutical Assesor, Medicines & Healthcare products Regulatory Agency (MHRA)
    Matthew Nicolas

    Matthew Nicolas

    Investigator, GlaxoSmithKline
    Nicolas Brandes

    Nicolas Brandes

    Director Global Product Management Polymer Prefilled Systems and Vial Containment, West Pharmaceutical Services
    Nicolas Eon

    Nicolas Eon

    Senior Global Product Manager, SCHOTT Pharmaceutical Systems
    Olaf Lebau

    Olaf Lebau

    Design Engineer for Medical Devices and Combination Products, Boehringer Ingelheim GmbH
    Orfeo Niedermann

    Orfeo Niedermann

    Business Development Director, Ypsomed
    Reinhard Scheller

    Reinhard Scheller

    Commercial Manager COP Europe, Zeon Europe GmbH
    Remy Vomscheid

    Remy Vomscheid

    Director, Devices Development & Technologies, IPSEN Pharmsciences
    Torsten Kneuss

    Torsten Kneuss

    Quality Assurance Manager Combination Products, Bayer Pharma

    Abha Raveau-Violette

    Device Manager, AstraZeneca
    Abha Raveau-Violette

    Abha Raveau-Violette has a Masters in Mechanical Engineering from the State University of New York with over 11 years of experience in design, development, and manufacturing of Combination Products and Medical Devices in Europe and the US.

    She has developed complex endovascular devices, combination products and managed high impact legacy products with a wide range of application from endovascular devices to injectables. These include pre filled syringes, autoinjectors, stents and stent delivery systems.

    Her personal motto is the quote from Maya Angelou, ‘People will forget what you said, people will forget what you did but people will never forget how you made them feel’ and she brings this to life by helping improve patients’ lives by solving complex device problems.
     

    Alison Bascou

    Senior Manager Regulatory Affairs, Beckton Dickinson (BD)
    Alison Bascou

    Alison Bascou is currently Senior Regulatory Affairs Manager for Regional Customers in US, Europe, Latin America & Greater Asia at BD Medical-Pharmaceutical Systems located in France. In her current role, she leads a team dedicated to supporting customers in their WW registrations of drug-device combination products and medical devices.
    Prior to this role, she held positions of increasing responsibility in customer facing teams and innovation product projects. Prior to joining BD in 2012, she worked in generic pharmaceutical companies in France and Germany.
    Alison Bascou holds a PhD in Chemistry from the RWTH University of Aachen (Germany), a Chemical Engineering degree from the Ecole Centrale in Marseille (France) as well as a Master in Health Law from the Universities of Sceaux & Châtenay-Malabry (France).

     

    Amanda Matthews

    Senior Director, Pfizer UK Limited
    Amanda Matthews

    Amanda has 20 years industry experience working at Pfizer, UK. Her career started as an Analytical Chemist before moving into the Regulatory field. For the past 15 years Amanda’s focus has been providing strategic support to global development programs and lifecycle management for a range of medical device and combination products. Amanda is an active participant in industry associations, namely CPC and EFPIA/EBE working groups focusing on drug-device combinations. Amanda is a contributor to ISO/TC84 and worked on the pending ISO 20069 standard for assessment of changes to drug delivery systems as well as contributing to ISO 11608 revisions.

    Anil-Kumar Busimi

    Strategy and Innovation, Senior Global Product Manager, iQ Platform, SCHOTT Pharmaceutical Systems
    Anil-Kumar Busimi

    Anil Busimi started his professional career in 2003 at SCHOTT AG in Germany. He worked in different roles including business development, project manager, and consultant in corporate strategy. In 2005, he moved to SCHOTT Pharmaceutical Packaging business and played a key role in building long-term business strategy with sound understanding of market trends, customer needs and competitive landscape. He has more than 10 years experience in product management and innovation. From August 2009 until June 2016, he held various positions in global product management for pre-fillable syringe business including glass and polymer PFS solutions. Currently, he is in the strategy & innovation team as senior global product manager for Cartridges and led the iQ™ Platform market launch. He is a professional speaker at many conferences and seminars on topics related to parenteral primary packaging and drug delivery devices.
    He holds M.Sc. degree in Agriculture and Genetics and a MBA.
     

    Benjamin Werner

    Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG
    Benjamin Werner

    Benjamin Werner obtained his Master degree in Pharmacy from the University of Munich. After his education Mr. Werner joined the group of Prof. Dr. Gerhard Winter at the Chair of Pharmaceutical Technology and Biotechnology at the University of Munich for his PhD and visited the University of Kansas for a research stay. During his studies he took part in collaborations with the industry and gained experience in the area of protein formulation, stabilization and analysis. In the last years he focused on novel primary packaging materials and other strategies to diminish protein particles in solutions which may cause immunogenicity after administration. Mr. Werner joined Boehringer Ingelheim last year as a Scientist. He is responsible for the primary packaging and process development of parenteral drugs.

    Carsten Worsoe

    Principal Scientist, Novo Nordisk
    Carsten Worsoe

    Cedric Gysel

    Healthcare Solutions Manager, Johnson & Johnson
    Cedric Gysel

    Cedric is a Healthcare Solutions Manager at Johnson&Johnson Design where he is responsible for Patient Centered Design initiatives supporting Janssens (Pharmaceutical Companies of J&J) R&D and Supply Chain portfolio driving better outcomes and user experience using a care centered approach. He holds a Master in Medical Device Technology from the University of Applied Science at Bern, Switzerland and has more than 10 years of experience in device development and lifecycle management.

    Christa Jansen-Otten

    Director Global Product Management, Prefilled Systems & Delivery, West Pharmaceutical Services
    Christa Jansen-Otten

    Since joining West in 2005 Christa has become an expert in Prefillable Systems and Delivery Technology in the Technical Customer Service and Marketing Departments. She has 20 years’ experience within the pharmaceutical industry, working in Quality in sterile filling, packaging and syringe manufacturing. She has been in her current position in West since 2016.

    Christa holds a Diploma in Biomedical Engineering from the University of Aachen, Germany.
     

    Cinzia Rotella

    Senior Materials Scientist, Sanofi
    Cinzia Rotella

    Cinzia studied material science at the University of Pisa (Italy) then I did my Phd on the “glass transition of confined polymers probed by spectroscopy” (polymer physics) at KULeuven (Belgium) followed by a post-doc at ESPCI Paris on rheology of innovative polymer materials. 
    Cinzia joined Sanofi, and the PCD MED team, in July 2016 as a material scientist. I am in charge of the material lab and of developing methods to characterize materials. I am also am responsible of studies (projects) related to rubber tribology and to the mechanical properties of glass primary containers.
     

    Clemens Guenther

    Director Nonclinical Safety Consumer Care, Bayer
    Clemens Guenther

    Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
    He started his professional career in 1990 at Schering AG, Berlin-Germany.
    From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects.
    After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals.
    Meanwhile Dr. Clemens Günther has gained about 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.
     

    Colin Roscoe

    Principal Human Factors Scientist, Teva Pharmaceuticals
    Colin Roscoe

    BSc (Hons), Diploma of Professional Studies
    2 years at Teva including experience on Specialty, Generic and Biosimilar projects. These projects include Prefilled syringe, Autoinjector, Reconstitution Kits and Container Closures and device peripherals at various stages of devolvement from pre-submission to remediation. Intended applications have included Osteoporosis, Antipsychotics, Migraine, Oncology and Eyedroppers
    6 years professional experience as a Human Factors Scientist / Ergonomist working at both Ford and Bombardier. Experience with Motion Capture, Investigative and Applied Ergonomics, Vison Ergonomics Research, Production Line Design, HF Design Assurance, User trials of prototype technologies
     

    Hiroki Hasegawa

    Researcher, Mitsubishi Gas Chemical Company, Inc
    Hiroki  Hasegawa

    Mr. Hiroki Hasegawa is a researcher of Advanced Business Development Division.
    He gained a Diploma in Science in 2013 and a Master Degree of Science in 2015 from Osaka University.
    Since April 2015 he has been working for Mitsubishi Gas Chemical Company, Inc. and in charge of macromolecular science, especially in composition development of thermosetting resin.
    Since 2018 he has joined a development team of multilayer plastic vial & syringe for biologics.
     

    Horst Koller

    CEO, HK Packaging Consulting GmbH
    Horst Koller

    Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing on Technical,
    Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.
     

    James Mellman

    Device Manager, Novartis A G
    James Mellman

    James is a device manager for Novartis in Basel, Switzerland. His main responsibilities include developing primary packaging systems for combination products and supporting new technologies. He has worked on a multitude of injection device platforms including pre-filled syringes, needle safety devices, auto injectors, and patch injectors. He has also helped to build and implement a renovated CCIT strategy for the Novartis Group. Before Novartis, James worked at Pfizer in their Devices Center of Excellence in Cambridge, UK (2008-2011) and Nutricia in their Advanced Medical Nutrition Division HQ in Amsterdam, NL (2011-2014). He received his PhD from the University of Florida in Materials Science & Engineering in 2007 specializing in biomaterials.

    Jochen Heinz

    Director New Products and Technology, Transcoject GmbH
    Jochen Heinz

    o Master of Engineering for Material-science and -Technology
    o Dissertation in cooperation with Schott Glas about optical glasses
    o Since 1991 at Schott Glas / Central Research concerned with different topics
    o Since 1995 at Schott Glas / Pharmaceutical Packaging development of prefillable plastic containers, since 1999 Head of New-Product Development
    o Since 2001 at Transcoject in different position.
     

    Kewei Yang

    Pharmaceutical Scientist, Roche
    Kewei Yang

    Dr. Kewei Yang is a pharmaceutical scientist and project leader in F. Hoffmann-La Roche Ltd. (Switzerland), Department of Pharmaceutical Development & Supplies, specializing in development of parenteral drug products for both small and large molecules, device combination products, manufacturing process, evaluation of novel advanced drug delivery systems.
    Before joining Roche he has worked on the development of nano-medicine for parenteral application in Novartis in Switzerland. Dr. Yang studied pharmaceutical science in Peking University in China and obtained his PhD degree of pharmaceutical technology in Friedlich-Schiller University of Jena in Germany. He has published dozens of papers and a few patents.
     

    Khaudeja Bano

    Head of Medical Devices, Abbott Molecular Inc
    Khaudeja Bano

    Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

    She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

    She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
     

    Lise Vanderkelen

    Department Head, Nelson Labs NV
    Lise Vanderkelen

    Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2013 as study director at the Extractables & Leachables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. In 2016, she became Department Head Pharma Services at Nelson Labs Europe. The main focus of this department is identifying organic impurities in drug products as well as in use stability of drug-device combination. In 2017, the scope expanded and includes now also all microbiological testing offered at Nelson Labs Europe.

    Marion Westwood

    Pharmaceutical Assesor, Medicines & Healthcare products Regulatory Agency (MHRA)
    Marion Westwood

    Dr Marion Westwood, is a senior pharmaceutical assessor from the Medicines and Healthcare products Regulatory Agency (MHRA) licensing division. She is an assessor in the team responsible for oncology and rheumatology products.

    Marion completed her PhD in drug delivery from biomaterials at Queens University, Belfast.
    She has worked at the MHRA for more than 9 years and has a wide range of experience in regulatory processes for almost all types of submissions, including generic applications and new active substances.
    Marion has a particular interest in drug device combination products and is a member of the internal drug-device combination working group at the MHRA. She is also involved in the assessment of Notified Body consultations for ancillary medicinal substances in devices.
     

    Matthew Nicolas

    Investigator, GlaxoSmithKline
    Matthew Nicolas

    Nicolas Brandes

    Director Global Product Management Polymer Prefilled Systems and Vial Containment, West Pharmaceutical Services
    Nicolas Brandes

    Nicolas Brandes has worked within the pharmaceutical packaging industry for ten years in areas of business development, research & development, technical services and marketing.
    Currently in his role as Director Global Product Management, Nicolas is responsible for defining new market requirements, launching new products, supporting business development plans, and overall execution of global marketing strategies, all related to West’s portfolio of polymer container solutions.
    Dr. Brandes received his Ph.D. in Biology from the University of Wurzburg, Germany, after performing his research studies at the University of Michigan, USA.
     

    Nicolas Eon

    Senior Global Product Manager, SCHOTT Pharmaceutical Systems
    Nicolas Eon

    Dr. Nicolas Eon, graduated from Universities of Nancy and Nantes, holds a Fluid Mechanics & Energy Science Engineering degree, a Master Degree in Energetics and Heat Transfer and a PhD. in Biomechanics. He worked for 10 years in the Automotive Safety Industry where he led the System Engineering Department in a global leading company. He has joined BD Pharmaceutical Systems in 2008 where he was in charge of the Global Product Engineering for Prefillable Syringe Systems. In 2012, Nicolas joined SCHOTT AG as Business Development Manager for Glass and Polymer Prefillable Syringes. Since 2010, he has been an active expert in ISO Technical Committees (ie. TC 76 WG4, TC 210) as part of the French and Swiss delegation. He is now in charge of the Glass PFS Strategy, Innovation and Technology Roadmap at SCHOTT AG as Global Product Manager for syriQ® brand.

    Olaf Lebau

    Design Engineer for Medical Devices and Combination Products, Boehringer Ingelheim GmbH
    Olaf Lebau

    Design Engineer for Medical Device and Combination Products, Boehringer Ingelheim

    Olaf is an applied physicist by training with a broad knowledge in interdisciplinary fields like nanotechnology and biomimetics.
    Over the years, he has worked on extracorporeal circuits, in vitro diagnostic, predictive algorithms and complex drug delivery systems.

    After joining Boehringer Ingelheim, he is currently working on combination products for new pharmaceuticals as well as innovation projects for smart and connected drug delivery devices.
     

    Orfeo Niedermann

    Business Development Director, Ypsomed
    Orfeo Niedermann

    Orfeo Niedermann has been with Ypsomed since 2005 working with pharma and biotech partners to develop and bring to market innovative self-injection systems. He studied mechanical engineering at the ETH Zurich (MSc ETH) and management in Berne (MBA BFH) and has worked in various positions in engineering, project management, sales and management of technical products, and for more than 10 years in the field of medical devices.

    Reinhard Scheller

    Commercial Manager COP Europe, Zeon Europe GmbH
    Reinhard Scheller

    Professional Experience
    2003 – present Commercial Manager Cyclo Olefin Polymers (COP) for Europe at Zeon Europe GmbH , Düsseldorf / Germany
    • Responsible for the business development of Zeon’s Cyclo Olefin Polymers (COP) in Europe
    • Focus on medical/pharmaceutical , analytical/diagnostical and optical COP applications

    1996 – 2003 Sales Manager for Germany at Zeon Deutschland GmbH , Düsseldorf / Germany
    1991 – 1996 Sales Representative Speciality Rubbers at Zeon Deutschland GmbH , Düsseldorf / Germany
    1980 – 1991 Scientific co-worker at the Institut of Polymer Technology Dresden / Germany (today: Leibniz-Institute of Polymer Research Dresden)
    Education
    1975 – 1980 Studies of Materials Science (specialisation plastics technology and plastics processing) at Technical University Leuna-Merseburg / Germany
     

    Remy Vomscheid

    Director, Devices Development & Technologies, IPSEN Pharmsciences
    Remy Vomscheid

    Remy Vomscheid, Ph.D. has been working in the healthcare industry for the last 16 years. He coached biotech start-ups as Business Developer for Genopole, the biggest French Incubator dedicated to Life Sciences. After this, he joined Johnson & Johnson as Business Development Manager, Medical Devices & Diagnostics, EMEA and later moved to a commercial position as Regional Business Manager for LifeScan, the diabetes diagnostics franchise of J&J. Then, he led the technical development of connected & automated medical devices at Eveon, as Director of Development. As Director, Devices Development & Technologies, he currently leads the development of innovative devices at Ipsen.

    Severine Duband

    Global Category Manager, Nemera
    Severine Duband

    Severine Duband joined the marketing team at Nemera in 2018, and is in charge of the parenteral franchise. Ms Duband holds a Masters in Science in Business Marketing from EMLYON Business School, (Lyon, France). She has over ten years’ marketing experience with key competencies including strategic planning, NPD launches, project management, and team leadership in an international environment. At Nemera, she particularly focuses on the range of proprietary products, including Safe’n’Sound® add-on passive safety system & Safelia® autoinjector device.

    Torsten Kneuss

    Quality Assurance Manager Combination Products, Bayer Pharma
    Torsten Kneuss

     Torsten Kneuss studied Business Administration and Engineering. Since 1999 he has been working with pharmaceutical packaging materials, medical devices and combination products, including several years within the field of quality control, development, operations, and pharmacovigilance. Since November 2017 he is, as a Quality Manager Combination Products, responsible for devices and combination products within Bayer AG.
     

    Ubaldo Martin

    Inflammation Neuroscience and Respiratory GMED, AstraZeneca
    Ubaldo Martin

    Sponsors

    Exhibitors

    Official Media Partner

    Key Media Partners

    Supporters

    Workshops

    Pre-Filled Syringes and Injectable Drug Devices Workshop Day
    Workshop

    Pre-Filled Syringes and Injectable Drug Devices Workshop Day

    Copthorne Tara Hotel
    14th January 2020
    London, United Kingdom

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Preliminary Attendees

    Download

    Speaker Interview - Raphael Nudelman

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    Speaker Interview - Horst Keller

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    Speaker Interview with Hiroki Hasegawa

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    Speaker Interview with Abha Raveau Violette

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    Speaker interview with James Mellman

    Download

    Speaker interview with Torsten Kneuss

    Download

    Speaker Interview with Cedric Gysel

    Download

    Chair letter

    Download

    2020 Workshop Programme

    Download

    2020 Speaker Biographies

    Download

    2020 Conference Programme

    Download

    Past Attendees List

    Download

    PFS Infographics

    Download

    Presentation by Shota Arakawa, Mitsubishi Gas Chemical

    Download

    Presentation by Reinhard Scheller, Zeon

    Download

    Presentation by Suraj Ramachandran, Merck

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    Presentation by Michael Becker, Boehringer Ingelheim

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    Presentation by Lise Vanderkelen, Nelson Labs

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    Presentation by Kim Soholm Halskov, Novo Nordisk A/S

    Download

    Presentation by Davide Mercadante, Biogen

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    Presentation by Alexander Zurn, Novartis Device Development

    Download

    Sponsors


    BD Medical

    Sponsors
    http://www.drugdeliverysystems.bd.com

    As a partner of choice for the pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of ready-to-use drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems, self-injection systems and connected solutions that help ensure smooth delivery, regardless of drug complexity, viscosity and dosing volume.

    With an unbending emphasis on innovation and the highest level of technical expertise, BD Medical - Pharmaceutical Systems provides pharmaceutical and biotechnology companies with support and resources to help them achieve their goals. We support their product launch and life cycle management through sophisticated consultative, analytical and clinical services to help ensure drug compatibility and seamless systems integration, while accelerating time-to-market and reducing risk.

    More information available @ drugdeliverysystems.bd.com



    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Nelson Labs Europe

    Sponsors
    http://www.nelsonlabs.be

    Nelson Labs Europe is an independent contract research organization, specializing in and fully dedicated to providing premium Extractables & Leachables services to the pharmaceutical industry. Based in Belgium, Nelson Labs Europe supports pharmaceutical companies – across the globe in developing worldwide compliance testing strategies to qualify Container/Closure Applications and Pharmaceutical Production Equipment from an Extractables & Leachables perspective. Over the last 15 years, Nelson Labs Europe supported over 200 submissions to the FDA and to the EMA.

    From a quality perspective, Nelson Labs Europe is ISO 17025 accredited and GLP-certified. Nelson Labs Europe has received a GMP accreditation from the European Authorities.

    Nelson Labs Europe is FDA registered. In 2017, Nelson Labs Europe was successfully audited by the FDA.

    Nelson Labs Europe is part of Nelson Labs, the leading global micro-biological and analytical lab testing platform.

    Nelson Labs, along with sister companies Sterigenics and Nordion, are part of Sotera Health, the world’s leading, fully-integrated protector of global health.



    Nemera

    Sponsors
    http://www.nemera.net

    Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology & generics industries. Nemera always puts patients first, providing services and products for several key delivery routes: Parenteral, Ophthalmic, Nasal, Buccal, Auricular, Inhalation, Dermal/Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: - Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. - Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.


    SCHOTT

    Sponsors
    http://www.schott.com/pharma

    SCHOTT is a leading supplier of primary pharma packaging and analytical lab services. We provide quality solutions while meeting the highest demands. Our product portfolio includes ampoules, syringes, cartridges and vials made of glass and COC polymer. Our facilities and products comply with international standards for pharmaceutical needs.


    West Pharmaceutical Services, Inc.

    Sponsors
    http://www.westpharma.com/

    West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 net sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.


    ZEON Europe GmbH

    Sponsors
    http://www.zeon.eu/cop-copf-zeonex-zeonor-zeonorfilm.html

    Zeon Europe GmbH is the European marketing/sales organisation of Zeon Corporation / Japan. As part of specialty materials operations Zeon produces Cyclo-Olefin Polymers (COP) under the tradenames ZEONEX® and ZEONOR®. The balance of outstanding water barrier properties in combination with high purity, excellent chemical resistance, high transparency and low interaction with drugs, put ZEONEX® and ZEONOR® as a perfect alternative to glass or other plastics solutions for pharmaceutical and biopharmaceutical containers - such as Pre-filled syringes, cartridges and vials.

    Exhibitors


    Früh Verpackungstechnik AG

    Exhibitors
    http://www.fruh.ch/

    Früh Verpackungstechnik AG is located in Switzerland and Europe’s leader for contract packaging of medical devices. We have as well the Swiss Medic approval for secondary packaging of pharmaceuticals. Our expertise is the assembling (in ISO class 7 clean rooms) and packaging of pre-filled syringes for sterile applications with respecting cold chain requirements. Früh offers as well the production of pre-made packaging materials (blisters and pouches) in class 7 clean rooms.


    Harro Höfliger

    Exhibitors
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical, medical device applications and consumer products. Our core expertise with innovative machine platforms is in packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology. The portfolio of upscalable test machines and modules, as well as technology platforms to meet your precise requirements, comes from many years of experience in targeted research and development. Therefore, Harro Höfliger covers all phases of your project from the laboratory to high efficiency production.


    IPP

    Exhibitors
    http://ippgroupltd.com/

    Industrial Production Processes (IPP) Ltd is a technical distributor of manufacturing equipment to the medical device and pharmaceutical sectors, specialising in packaging equipment, packaging inspection equipment, pre-filled syringe and tablet inspection equipment, automation equipment and serialisation equipment.

    Visit us at the SMI Pre-Filled Syringe Conference 2020, alongside our Packaging Technologies and Inspection partner, PTI, our Container Closure Integrity Testing (CCIT) specialist, and check out its microcurrent HVLD technology – the optimal solution for all parental and biologic products.

    The E-Scan 655 technology is a MicroCurrent conductivity test method, HVLDmc , that is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity based solutions. The technology uses a non-contact and non-invasive test method that requires no sample preparation. PTI’s E-Scan 655 can be used with a wide range of liquid based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

    The E-Scan 655 features a fast test cycle and simple operation. Additional benefits include quick changeover and easy recipe setup to accommodate a wide range of products and applications. The offline E-Scan 655 method can be migrated from laboratory to 100% inline testing applications at high production speeds.

    Visit our booth to learn more.



    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.


    PHC Corporation

    Exhibitors
    http://www.phchd.com/global

    In April 2018, Panasonic Healthcare Holdings Co., Ltd. changed its name to PHC Corporation.

    For all the people who wish for better health. Over the approximately 70 years since our establishment, we have delivered groundbreaking products to the world. The newly created “PHC” will take on the challenge of providing ever new innovations, drawing on the spirit of monozukuri (Japanese manufacturing).We will continue to evolve as a provider of devices and services marked by PHC's precision technology in our three core business areas of Medical Devices, Healthcare IT, and Life Sciences.



    ZwickRoell

    Exhibitors
    www.zwickroell.com

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.

    Media Partners


    pharmaphorum

    Key Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Pharma Journalist

    Key Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    pharmanews hq

    Key Media Partners
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Pharmaceutical Technology

    Key Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    International Pharmaceutical Industry (IPI)

    Key Media Partners
    http://ipimediaworld.com/

    IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.


    World Pharma News

    Key Media Partners
    http://www.worldpharmanews.com/


    Media Partners


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Select Science

    Supporters
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    Bio Pharma Trend

    Supporters
    https://www.biopharmatrend.com/

    BiopharmaTrend is a market and business intelligence platform for drug discovery and biotech industry, focusing on emerging areas: artificial intelligence in pharmaceutical R&D, "digitalization" of the pharma industry, and technology/business trends in pre-clinical and clinical drug development. We also publish articles, commentaries and opinions contributed by top industry professionals.


    Drug Development & Delivery

    Supporters
    http://www.drug-dev.com

    Drug Development & Delivery is a print/online content provider that presents the latest scientific methods in drug development for professionals.


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

    Title

    SubTitle
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    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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