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SMi is proud to present the 13th Annual Pre-Filled Syringes Conference in London on 13th and 14th January 2021.

The pre-filled syringes industry is growing at an exponential rate. With increasing demand for self-administration, a rise in biologics, large-volume delivery and the delayed EU MDR at the forefront of the field, SMi’s 13th annual event will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.

Topics of discussion will include the latest updates on the EU MDR and Article 117, advances in novel drug products and biologics, parenteral packaging for pre-filled syringes, innovations in device design and platforms for combination products, lifecycle management and much more…

 

The 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.

As Europe’s first Pre-Filled Syringes Conference of 2021, this event is not to be missed. We look forward to welcoming you to the conference in January.

  • Engage with senior industry opinion leaders presenting their experiences and case studies in innovative device design and advanced drug product formulation 
  • Gain insights from notified body and competent authority representatives addressing key regulatory requirements
  • Understand how to optimize your lifecycle management strategy for a commercially successful device
  • Explore and benchmark against industry advances in device design through case studies and real world examples
     
  • 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:

Advanz Pharma; Aspen Pharma; AstraZeneca; Bayer AG; Bayer Pharma; Beckton Dickinson (BD); Becton Dickinson (BD); Becton Dikinson; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI Group; CCIT SA; Covestro Deutschland AG; Credence MedSystems, Inc.; Doublee Bond Pharmaceutical; Drug Discovery Support; Emergo by UL; Eveon; Fruh Verpackungstechnik AG; Gerresheimer Buende GmbH; GSK; Harro Hofliger; Harro Hofliger Packaging Systems Ltd; Haughton Design Ltd; HK Packaging Consulting GmbH; IPP; Ipsen; IPSEN Pharmsciences; Johnson & Johnson; Mallinckrodt; MHRA; Mitsubishi Gas Chemical Company, Inc; Mitsui Chemicals Inc.; Nelson Labs NV; Nemera; Novartis A G; Novo Nordisk; Novo Nordisk A / S; Owen Mumford; Pall Europe Ltd; Panasonic Healthcare Co., Ltd.; Pfizer; Pfizer Ltd UK; Pfizer R&D Ltd; Pfizer UK Limited; PHC Corporation; Regeneron Pharmaceutical Inc; Roche; SCHOTT Pharmaceutical Systems; SCHOTT Pharmceutical Systems; SI02 Medical Products ; Swiss Fillow AU; Teva Pharmaceuticals; Transcoject GmbH; UCB Celltech; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; Ypsomed; Zeon Europe GmbH; ZwickRoell GmbH & Co. KG; ZwickRoell Ltd;

Conference programme

8:00 Registration & Coffee

9:00 Chairs' Opening Remarks

Bjorg K Hunter

Bjorg K Hunter, Department Manager, RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk Pharma
View Bio

Alphons Fakler

Alphons Fakler, Head Medical Device Risk Management, Novartis Pharma AG
View Bio

9:10 An Industry Outlook: Latest regulatory challenges in Pre-filled syringe innovation

Bjorg K Hunter

Bjorg K Hunter, Department Manager, RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk Pharma
View Bio

  • Recent developments in drug delivery platforms and drug device design
  • New regulatory opportunities in device development and how have we seen the industry evolve
  • Delay in MDR deadline – how should industry make use of their year?
  • Implementation challenges of EMA Drug-Device Quality Guideline
     
  • 9:50 Device regulatory guidance during and post-pandemic

    Sarah Tang

    Sarah Tang, Regulatory Affairs Manager, Medicines & Healthcare Products Regulatory Agency (MHRA)
    View Bio

  • How is COVID-19 effecting the MHRA’s approach to drug/device combination product regulatory guidance
  • MHRA post-Brexit: Will the agency be providing guidance for the EU MDR and will there be any updates or changes to current parenteral device guidelines?
  • A future outlook of regulatory approvals for drug delivery devices in a post-pandemic world
     
  • 10:30 Leveraging the patient journey to optimize device use in home care environments

    Severine Duband

    Severine Duband, Global Category Manager, Nemera
    View Bio

  • A changing landscape for parenteral administration
  • Understanding the patient journey to provide better outcomes
  • A new generation of passive, add-on safety devices for larger volume biologic drugs
  • How can integrated services support the development of safe, effective, and differentiated combination products
     
  • 11:10 Morning Coffee

    11:40 Strategic platforms for pre-filled syringes

    Stefano Martini

    Stefano Martini, Responsible for Special Programs, Sanofi
    View Bio

  • What delivery systems and devices are suitable for platforms
  • Risk, clinical and usability testing for a successful platform
  • Challenges in platforms for novel drug products, when is a platform most beneficial for a product portfolio?
  • Leveraging platforms for optimal product success: A case study
     
  • 12:20 How to satisfy design validation for Pre-Filled Syringes

    Brian Holly

    Brian Holly, Head of Human Factors, Pfizer R&D Ltd
    View Bio

  • Prefilled syringe use environments and user populations
  • Options for satisfying design validation
  • How to you determine if human factors validation is required
  • Regulatory authority expectations pre and post approval
  • 13:00 Networking Lunch

    14:00 Improving subcutaneous injection for chronic care settings – Working together to innovate for impact

    14:40 Round Table Discussion: Assessing the PFS regulatory landscape

    With the evolving regulatory environment of pre-filled syringes and approaching implementation of the long-awaited EU MDR, the PFS community looks at the key considerations, challenges, and outlooks of the new guidance and how industry can prepare for the 2021 deadline.

    Topics that will be covered include:

  • Working with Notified Bodies: guidance and advice on clear reporting and documentation to minimise costs and time
  • A regulatory perspective on lifecycle management for injectable devices requires a notified body opinion
  • How has industry been implementing the draft guidance so far and what should we be doing with the extra year to prepare?
  • Bjorg K Hunter

    Bjorg K Hunter, Department Manager, RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk Pharma
    View Bio

    Jonathan Sutch

    Jonathan Sutch, Medicinal Specialist, BSI Group
    View Bio

    Julia Frese

    Julia Frese, Department Manaher Centre of Combination Products, TÜV SÜD

    Vikas Jaitely

    Vikas Jaitely , Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck

    15:40 Afternoon Tea

    16:10 Regulatory challenges in PFS when integrating digital technologies

    Vikas Jaitely

    Vikas Jaitely , Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck

  • Regulatory frameworks for pre-filled syringes
  • Integrating connected technologies
  • The current global regulatory environment
  • Challenges for a connected platform
     
  • 16:50 Case Study: MDR and Article 117 lessons learnt so far

    Jonathan Sutch

    Jonathan Sutch, Medicinal Specialist, BSI Group
    View Bio

  • An overview of current timelines and considerations for the 1 year delay
  • Case Study examples and key takeaways from applications so far
  • Common pitfalls in documentation and reporting 
  • Notified Body guidance on do’s and don’ts for a successful application
  • 17:30 Chairs' Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Bjorg K Hunter

    Bjorg K Hunter, Regulatory Manager, Devices, GSK

    Alphons Fakler

    Alphons Fakler, Senior Packaging Engineer, Novartis Pharma AG

    9:10 Evaluating and improving an already successful combination product

    Daniel Latham

    Daniel Latham, Head - Device Development & Commercialisation, Novartis

  • Future trends in parenteral drug delivery systems
  • Considering user feedback for next generation device development 
  • Implementing a strategy to achieve commercial competitiveness
  • Strengthening the supplier-customer relationship for a commercially successful product
  • 9:50 Prefilled syringes: Managing increasing volumes

    Abha Raveau-Violette

    Abha Raveau-Violette, Device Manager, AstraZeneca
    View Bio

  • Scaling up: Volume increase during development and post launch
  • Design controls and regulatory landscape to consider for scale up
  • Managing device design
  • Supplier relationship and agreements
  • Validation activities 
  • Scaling up: Challenges and Opportunities
  • 10:30 Technical overview of COP for Prefilled Syringes

    Carolina Sunjic

    Carolina Sunjic, Product Manager COP, Zeon Europe GmbH
    View Bio

  • Key properties of COP
  • Case Study:
  • Protein Adsorption of Biologics – COP vs Glass
  • Immunogenicity test of the aggregates
  • Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • 11:10 Morning Coffee

    11:40 Panel Discussion: Optimizing lifecycle management strategy for a commercially successful device

  • Post-launch change management for delivery devices
  • Collaborations and managing the supplier-customer relationship for continuous development post launch
  • Post market safety reporting for combination products and considering the evolving regulatory landscape
  • Considering and utilizing feedback post-launch
  • Alphons Fakler

    Alphons Fakler, Head Medical Device Risk Management, Novartis Pharma AG
    View Bio

    Daniel Latham

    Daniel Latham, Head Device Development & LCM, Novartis
    View Bio

    Stefano Martini

    Stefano Martini, Responsible for Special Programs, Sanofi
    View Bio

    Abha Raveau-Violette

    Abha Raveau-Violette, Device Manager, AstraZeneca
    View Bio

    12:20 Optimising drug product formulation and the link to PFS

    Rene Holm

    Rene Holm, Head & Scientific Director, Janssen
    View Bio

  • Advancements of long acting injectable formulations and sustained release
  • Challenges in platform development for complex delivery technologies
  • How does the future look with respect to drug delivery technologies and PFS delivery
  • 13:00 Networking Lunch

    14:00 Nonclinical safety considerations for a PFS & Injectable Drug Device

    Clemens Gunther

    Clemens Gunther, Director Nonclinical Safety Consumer Care, Bayer AG
    View Bio

  • Understanding the complexity of non-clinical safety requirements
  • How to perform biocompatibility testing according to ISO-10993
  • Specific aspects to consider for PFS/IDD delivering biologics

     

  • 14:40 Afternoon Tea

    15:10 Human Factors Patch Pump Pipeline Planning

    Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

  • Forming a platform HF strategy
  • Gather inputs: Device competitive intelligence and analysis of known use problems
  • Assessing the potential users in your pipeline
  • Leveraging existing development activities to gain additional insight
  • 15:50 Challenges and advances in microneedle technology

    James  Birchall

    James Birchall, Professor of Pharmaceutical Sciences, Deputy Head of School, Cardiff University
    View Bio

  • Healthcare applications for microneedles
  • Microneedle design and formulation integration
  • Considerations for industrial manufacture and clinical adoption
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Abha Raveau-Violette

    Abha Raveau-Violette

    Device Manager, AstraZeneca
    Alphons Fakler

    Alphons Fakler

    Head Medical Device Risk Management, Novartis Pharma AG
    Bjorg K Hunter

    Bjorg K Hunter

    Department Manager, RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk Pharma
    Brian Holly

    Brian Holly

    Head of Human Factors, Pfizer R&D Ltd
    Carolina Sunjic

    Carolina Sunjic

    Product Manager COP, Zeon Europe GmbH
    Clemens Gunther

    Clemens Gunther

    Director Nonclinical Safety Consumer Care, Bayer AG
    Daniel Latham

    Daniel Latham

    Head Device Development & LCM, Novartis
    James  Birchall

    James Birchall

    Professor of Pharmaceutical Sciences, Deputy Head of School, Cardiff University
    Joel Richard

    Joel Richard

    Chief Development Officer, MedinCell
    Jonathan Sutch

    Jonathan Sutch

    Medicinal Specialist, BSI Group
    Julia Frese

    Julia Frese

    Department Manaher Centre of Combination Products, TÜV SÜD
    Rene Holm

    Rene Holm

    Head & Scientific Director, Janssen
    Sarah Tang

    Sarah Tang

    Regulatory Affairs Manager, Medicines & Healthcare Products Regulatory Agency (MHRA)
    Severine Duband

    Severine Duband

    Global Category Manager, Nemera
    Stefano Martini

    Stefano Martini

    Responsible for Special Programs, Sanofi
    Tiffany McIntire

    Tiffany McIntire

    Senior Human Factors Engineer, Roche
    Vikas Jaitely

    Vikas Jaitely

    Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck

    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.
     

    Alphons Fakler

    Head Medical Device Risk Management, Novartis Pharma AG
    Alphons Fakler

    Alphons Fakler is heading the Medical Device Risk Management group in Technical Research and Development at Novartis Pharma in Basel. He holds a degree as pharmacist from Ludwig-Maximilian-University Munich where he graduated in 1993. He joined Novartis in 2012 coming from Schott Pharmaceutical Packaging where he served in several functions at last as Head of Product and Process Development Sterile Products. For more than 20 years, he is working in the field of developing products and devices for pharmaceutical and biotech applications.

    Andrew Dundon

    Founder, PharMechceutics Ltd
    Andrew  Dundon

    Andrew is founder of PharMechceutics Ltd. an independent consultancy specialising in supporting clients to design, develop and industrialise robust, differentiated patient centric drug delivery systems. Andrew was formerly Head of Device Engineering at GSK R&D.
    At GSK, Andrew led or assumed accountability for key deliverables in the development and market authorisation of the pMDI counter, Veramyst/Mistrpo™, Ellipta™ inhaler, a platform autoinjector and a number novel drug delivery devices.
    Andrew has a passion for influencing how drug delivery systems should be most effectively developed using a risk-based approach informed by the regulatory framework within which companies are required to operate.
     

    Bjorg K Hunter

    Department Manager, RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk Pharma
    Bjorg K Hunter

    Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK in 2010 and has held different roles within the Device development field primarily in the late stage parenteral area. She has held positions with increased resistibility stating as device lead for key GSK parenteral devices and progressing into leading a device management team, where she has had the accountability of project management and regulatory compliance for parenteral devices. Later Bjorg moved into a key management role in CMC regulatory where she was responsible for the global regulatory and advocacy strategy for GSK’s portfolio of devices across modalities and lifecycle. In May 2020 Bjorg took up a new position in NovoNordisk where she lead the NexGen Drug-Device RA department within RA CMC and Devices where she has RA accountability for both early and late stage drug-device combination products.

    Brian Holly

    Head of Human Factors, Pfizer R&D Ltd
    Brian Holly

    Brian Holly heads up human factors engineering at Pfizer’s Devices Centre of Excellence within the BioTherapeutics Research and Development Division, based in Cambridge UK. Brian has 23 years’ experience in the healthcare sector and has been at Pfizer for the past 12 years. Brian has worked on a wide variety of drug delivery system development programs including management of post market product activities. Brian has developed expertise in human factors engineering including user interface design, risk management, design controls, and regulatory activities for combination products and medical devices, and he is no stranger to FDA interactions regarding human factors.

    Carolina Sunjic

    Product Manager COP, Zeon Europe GmbH
    Carolina Sunjic

    Carolina is Product Manager for Cyclo Olefin Polymers at Zeon Europe and she is responsible for business development and marketing of Zeon Corporation’s highly transparent resins ZEONEX® and ZEONOR® in Europe. After joining Zeon in 2013 as Sales Representative to strengthen the company's presence in Iberia, she will support the ambitious projects for COP business ahead in medical/pharma applications such as primary packaging in PFS & injectable drug devices. Carolina holds a degree in Chemical Engineering from IQS University in Barcelona and is currently pursuing an MBA from EAE Business School.

    Clemens Gunther

    Director Nonclinical Safety Consumer Care, Bayer AG
    Clemens Gunther

    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 and later-on Senior Expert Nonclinical Safety 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 in various medical indications.
     

    Daniel Latham

    Head Device Development & LCM, Novartis
    Daniel Latham

    Daniel Latham is the Head of Device Development & LCM, where he leads an organisation responsible for the development and life cycle management of delivery systems of drug/device combinations for both new biologic entities, biosimilars, and new chemical entities. Over the past 14 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer healthcare, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, University of London and a bachelor’s degree and master’s degrees in engineering from the University of Sheffield.

    James Birchall

    Professor of Pharmaceutical Sciences, Deputy Head of School, Cardiff University
    James  Birchall

    Professor Birchall graduated from Bath University in 1993 and completed his PhD researching drug and DNA delivery systems in 1998 (Cardiff University). Current research is focused on microneedle drug and vaccine delivery to the skin and pulmonary drug delivery. Professor Birchall has acted as Associate Editor of Critical Reviews in Therapeutic Drug Carrier Systems, a temporary advisor to the WHO and an expert panel member to the British Pharmacopoeia and conducted research funded by the EU, DFID, Bill and Melinda Gates Foundation, NIH, Wellcome Trust, EPSRC, MRC, Welsh Government, Royal Society, Innovate UK and various charities and pharmaceutical companies.

    Joel Richard

    Chief Development Officer, MedinCell
    Joel Richard

    Dr Joël Richard is currently Chief Development Officer and Executive Committee Member at MedinCell (Montpellier, France). He is leading all the development activities of the company, based on the proprietary technology BEPO® for Long-Acting Injectables. (LAIs). These activities comprise formulation and process development, device development, analytical development, process transfer and scale-up, non-clinical development, manufacturing and supply of clinical batches, regulatory affairs and clinical development operations, quality and regulatory compliance. Dr Richard has more than 30 years of experience in chemistry and (bio)pharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Ipsen (France), Serono (Italy), MerckSerono (Germany), Ethypharm (France). Dr Richard has focused his research activity on new formulation technologies and innovative drug delivery systems (microspheres, nanosystems, self-assembling gels), especially for injectable peptide and protein formulations. He has graduated from Ecole Normale Supérieure (Cachan, France), and got a PhD in Materials Science (Paris VI, France), and the “Habilitation à Diriger les Recherches” in Chemistry (Bordeaux I, France). He also had an entrepreneurial experience, co-funding Mainelab (France) with Pr Jean-Pierre Benoit, a drug delivery company specialized in developing solvent-free processes for protein delivery systems. He has published 70 peer-reviewed scientific papers, 8 book chapters and 2 review editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein formulations, sustained-release formulations…). He is the author of 140 international communications and 55 patent families. He has also been serving as an APGI Board Member for 3 years and is a Member of the Controlled Release Society (CRS).

    Jonathan Sutch

    Medicinal Specialist, BSI Group
    Jonathan Sutch

    Dr Jonathan Sutch is a medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 3 years ago.

    Julia Frese

    Department Manaher Centre of Combination Products, TÜV SÜD
    Julia Frese

    Rene Holm

    Head & Scientific Director, Janssen
    Rene Holm

    René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science covering both small and large molecules and is now responsible for the functional unit ensuring development of all non-solid formulations for Janssens small molecule value stream.

    Dr. Holm is (co-) author of more than 185 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is a honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark.
     

    Sarah Tang

    Regulatory Affairs Manager, Medicines & Healthcare Products Regulatory Agency (MHRA)
    Sarah Tang

    Sarah currently occupies the position of Regulatory Affairs Manager in the Devices Division of the Medicines and Healthcare products Regulatory Agency (MHRA), where she provides advice and guidance on medical devices legislation in the UK. A significant amount of her work focuses on issues around borderline areas, classification queries and drug-device combination products. She also previously worked as part of the team responsible for the UK implementation of the new EU Regulations for medical devices.

    Prior to joining the MHRA, Sarah worked as a veterinary surgeon, where she developed her interest in how medical devices and medicines are regulated.
     

    Severine Duband

    Global Category Manager, Nemera
    Severine Duband

    Séverine Duband is Category Manager at Nemera in charge of the parenteral franchise. She’s highly focused on developing Nemera’s range of proprietary products including Safe’n’Sound®, the passive safety device platform for prefilled syringes. Ms Duband joined Nemera in 2018. She has more than ten years’ marketing experience in fast-moving consumer goods with key competencies including strategic planning, NPD launches, project management, brand communication and team leadership in an international environment. Ms Duband has a Masters in Science in Business Marketing from EMLYON Business School, Lyon, France.

    Stefano Martini

    Responsible for Special Programs, Sanofi
    Stefano Martini

    I joined Sanofi France, on June 2016 in Medical Devices – PCD initially as Responsible of External Projects (June 2016-March 2018), then as Head of Operations of PC Early Stage and Platform Development (April 2018-June 2020) and as of today as Responsible of Special Programs.

    Over the last 30+ years I have gained a huge knowledge about PC development, working from 2013 to 2016 as Responsible of the Primary Component Characterisation laboratory at Amgen LTD in Ireland and before then for 20+ years at Stevanato Group in several managerial position in both operations and development for ampoules, vials and PFS.

    I hold a BSc in Pharmaceutical Technologies from TU Dublin and a Lean Six Sigma Black Belt certification.
     

    Tiffany McIntire

    Senior Human Factors Engineer, Roche
    Tiffany McIntire

    Tiffany McIntire has been working as a Human Factors Engineer in the pharmaceutical industry for 6 years developing delivery systems, labeling strategies, co-packed products, and new solutions. After her studies in Industrial/Organizational Psychology, she started her career at Lilly where she worked on a range of combination products including dial-and-dose insulin injectors, autoinjectors, pre-filled syringes, digital products, and nasal glucagon. While working at Lilly, she began taking Human-Computer Interaction night courses to deepen her knowledge of digital product development. After, she jumped across the pond to Germany to join a recently established device group within Boehringer Ingelheim (BI). Her core contributions in this position were deepening the team's knowledge of HF and advocating for QMS improvements. While there she worked on an AI and a PFS program, a transfer system, and an occular injection system. After her time at BI, she briefly freelanced before joining the Roche team in Basel where she is currently working.

    Vikas Jaitely

    Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck
    Vikas Jaitely

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    Workshops

    Challenges and drivers for development of Long Acting Injectables
    Workshop

    Challenges and drivers for development of Long Acting Injectables

    Copthorne Tara Hotel
    12th January 2021
    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

    Past Presentation – Abha Raveau-Violette, AstraZeneca

    Download

    Past Presentation – Clemens Guenther, Bayer

    Download

    Past Presentation – Matthew Nicolas, GSK

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    Past Presentation – Cedric Gysel, Johnson & Johnson

    Download

    Past brochure

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    Infographic

    Download

    Past delegate list

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    Sponsors


    BD Medical - Pharmaceutical Systems

    Sponsors
    https://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 a high 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



    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.


    ZEON

    Sponsors
    http://www.zeonex.com

    ZEON is one of the world’s leading producers of specialty elastomers, polymers and specialty chemicals. ZEON operates a global network of plants in Asia and North America, and R&D centers in Japan, USA, China and Singapore. With almost 70 years of business ZEON has the experience and expertise in C4- and C5-chemistry to offer a wide range of innovative products.

    Zeon will present ZEONEX® and ZEONOR Cyclo Olefin Polymers (COP) which are fully amorphous and highly transparent thermoplastic resins. ZeonorFilm™ is the first high performance optical film in the world successfully produced using film extrusion technology.


    Exhibitors


    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


    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.

    Media Partners


    Pharma Journalist

    Official Media Partner
    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.


    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


    Technology Networks

    Supporting Media Partners
    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


    Gate2Biotech

    Supporting Media Partners
    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.


    International Pharmaceutical Industry (IPI)

    Supporting 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.


    pharmanews hq

    Supporting 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.


    Pharmalicensing

    Supporting Media Partners
    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.


    SciDoc Publishers

    Supporting Media Partners
    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.


    pharmaphorum

    Supporting 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


    Pharmaceutical Technology

    Supporting 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.


    Farmavita

    Supporting Media Partners
    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!


    Pharmacircle

    Supporting Media Partners
    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….


    Drug Discovery Today

    Supporting Media Partners
    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.


    World Pharma News

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



    Swiss Biotech Association

    Supporting Media Partners
    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.

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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.

     

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    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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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