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Remote Access Only Announcement

Due to ongoing concerns over COVID-19 we have now made this conference a virtual event. All speakers, attendees and sponsors will be able to access the full conference and its materials and will be able to log on remotely via the internet. Please contact a member of the SMi Team for more information customerservices@smi-online.co.uk

SMi is delighted to announce its 4th Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 11th-12th May 2020.

The increasing demand for medicines that target diseases more effectively and with fewer side effects is leading HPAPI market expansion with a CAGR of 10.3%. It is forecasted that by 2024, the HPAPI oncology market will be worth close to $100 billion.

As such, these highly potent substances predispose workers to higher risks of exposure and consequently, need to be manufactured according to strict criteria. Limiting exposure has become one of the biggest hurdles of the HPAPI industry resulting in an increasing need for containment solutions aimed to reduce the risk of hazard and to prevent cross-contamination. With elevated risk come stricter regulatory guidelines that pharmaceutical companies and contract manufacturers need to adhere to.

The 4th year of this conference series focuses on the growing HPAPI landscape driven by the demand for highly potent drugs in oncology, diabetes and autoimmune disease treatment. This event will address the biggest challenges the industry is facing with regards to determining toxicology limits, assessing hazards, implementing risk procures, translating risk assessment into facility engineering, preventing and dealing with cross-contamination and adhering to GMP regulatory guidelines.

Attend this conference and join our networking platform for industry professionals to provide you with the expertise to overcome the challenges of the HPAPI industry.

  • Explore HPAPI manufacturing with 8 big pharma from both the toxic substance and the employees’ perspective
  • Gain better understanding of human factors and ergonomics aspects and their role in improving production performance – NEW FOR 2020!
  • Deep dive into the oncology market and ADC production, the main driver of the HPAPI industry- NEW FOR 2020!
  • Learn what it takes to create a safety company culture and how to better train your employees on risk perception
     

Directors, Heads, Managers, Principal Scientists of :

  • Occupational Toxicology
  • Industrial Hygiene
  • EHS/ SHE
  • Validation
  • Risk Assessment
  • Containment Engineering
  • Manufacturing/ Production
  • Process Development
  • Supply Chain/ Operations
  • Product Quality
  • Formulation Development
  • Regulatory

3i France; 3P Innovation Ltd; AbbVie; Accord UK; ADC Biotechnology Ltd; Antikor Biopharma Ltd; Ascendis Pharmaceuticals; AstraZeneca; Bayer AG; Bayer Pharma; Boehringer Ingelheim Pharmaceuticals, Inc.; BSP Pharmaceuticals S.p.A.; Catalent Pharma Solutions Inc; Dec Group; DSTL; Egis Pharmaceuticals PLC; Ferring Pharmaceuticals A/S; Gedeon Richter Plc.; GSK; GVK Biosciences; HPAPI Project Services Limited; Ipsen Bionnovation Ltd; Laurus Synthesis; MedinCell; Minakem; NNE AG; Novartis Ag; Novo Nordisk; Novo Nordisk A / S; NPI & Product Technology; Oril Industrie; PCI Pharma Services; Pharmadagio Limited; Regeneron Inc; SafeBridge Consultants, Inc; SafeBridge Europe Ltd; SK Biotek; Solo Containment; Speciality Chemicals ; Takeda Pharmaceuticals;

Conference programme

9:00 Chair's Opening Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

9:10 Characterizing Highly Potent APIs – Introduction to Occupational Toxicology

Martin Kohan

Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
View Bio

• Toxicology – What makes a compound highly potent?
• Occupational Toxicology and Exposure Limits (OELs & PDEs) and Bands (OEBs)
• How are Exposure Limits and Bands established?
• Why we need Exposure Limits and Bands?

9:50 Occupational Banding Systems

William Hawkins

William Hawkins, Manager Occupational Toxicology, GSK
View Bio

• A brief history of occupational exposure banding.
• The use of Occupational Banding systems
• Toxicology of new compounds with novel mechanism of action – a case study

10:30 Morning Break

11:00 Respirators and their effectiveness in reducing particulate exposures

John Cherrie

John Cherrie, Professor of Human Health, Heriot-Watt University
View Bio

• Respirators are widely used to protect workers from inhaling airborne dusts, including APIs
• It is often said that respirators are ineffective, but if used properly they can offer a high degree of protection
• Selection of the right equipment and training of the workers to wear it correctly will ensure the best outcome
• Respirators should be used in conjunction with engineering measures in a comprehensive exposure control programme

11:40 PANEL DISCUSSION: Synchronizing pharma and CMOs – on the way to an ideal partnership

• What is essential for a good relationship between pharma and solution providers
• What are the challenges involved in incorporating outsourced manufacturing into the global pharma supply chain
• Addressing the need for transparency on the lack of data-driven approaches for managing occupational safety
• How could relationships be improved for achieving better workflow

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

Ulrich Rumenapp

Ulrich Rumenapp, Head of Launch Preparation and Coordination, Bayer AG
View Bio

Mike Perry

Mike Perry, Director, Pharmadagio Limited
View Bio

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

12:20 Lunch Break

13:20 ADC production - Cleaning and Cross-Contamination aspects

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

-Overviewing cleaning requirements for ADCs
-Assessing the potential of robotics in containment
-Cleaning and Cross-Contamination control in ASDC production

14:00 Performance Beyond ‘The Number’ – Exploring the Reliability of Containment Performance Data

Mike Perry

Mike Perry, Director, Pharmadagio Limited
View Bio

• The role, scope and limitations of containment performance testing explained
• Interpreting the ISPE Guide – how choice of sampling strategy, data interpretation, human factors and statistics will influence test outcomes
• Purchasing containment equipment and communication – examples of marketing language and finding the right questions to ask.
• Pushing the boundaries – the role of containment performance testing in HPAPI settings

14:40 Afternoon Break

15:10 Practical Steps for Delivering HPAPI Projects – part 1

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

  • Strategic HPAPI Project Considerations
  • Hazard Assessment - It All Starts with the Hazard
  • Process is Primary
  • Real Risk Assessment - Risk to Product and Risk to Workers
     
  • 15:50 Practical Steps for Delivering HPAPI Projects- part 2

    Justin Mason-Home

    Justin Mason-Home, Director, HPAPI Project Services Limited
    View Bio

  • Facility Design Features
  • Containment for Higher Risk Activities and Control for Lower Risk Activities
  • Verification of Control/Containment Performance
  • Occupational health and safety management systems
  • 16:10 Chair's Closing Remarks and Close of Day One

    Justin Mason-Home

    Justin Mason-Home, Director, HPAPI Project Services Limited
    View Bio

    9:00 Chair's Opening Remarks

    Justin Mason-Home

    Justin Mason-Home, Director, HPAPI Project Services Limited
    View Bio

    9:10 Comparison of Occupational Hygiene Monitoring according to EN 689 and the SMEPAC Guideline

    Friederike Hermann

    Friederike Hermann, Head of Occupational Hygiene, Lonza
    View Bio

  • The aim of occupational exposure monitoring 
  • The basics of OH-monitoring
  • Strategy for testing compliance: EN 689 versus SMEPAC–Testing
  • Interpretation of monitoring results 
  • Are OELs applicable for incidents?
  • Examples
  •  

    9:50 CMC Strategies For The Timely Launch Preparation of Antibody-Drug-Conjugates as High Potent APIs

    Ulrich Rumenapp

    Ulrich Rumenapp, Head of Launch Preparation and Coordination, Bayer AG
    View Bio

    • The manufacture of highly potent ADCs - challenges and solutions
    • Deciding when to outsource and when to keep in-house
    • Bayer’s ADC production concept
    • Best practices for CMO selection and outsourcing ADC development and manufacture
    • The journey from development to launch - understanding the needs, solutions, risks and mitigations

    10:30 Morning Break

    11:00 Engineering in support of ADC containment – a case study

    Peter Marshall

    Peter Marshall, Associate Engineering Director, AstraZeneca
    View Bio

    • Innovative solutions to dealing with increasing toxicity of ADCs
    • Designing ADC containment systems
    • The containment of ADCs – a case study from AZ

    11:40 Manufacturing of Oncological Products: a perspective by a CDMO

    Fabio  Zenobi

    Fabio Zenobi, EHS Director & QP, BSP Pharmaceuticals S.p.A.
    View Bio

    • New Product Introduction
    • Cross Contamination Risk Assessment & Environmental Risk Assessment
    • Case Study: ADC Manufacturing

    12:20 Lunch Break

    13:20 Putting the human at the centre of system design in HPAPI manufacturing

    Brian Edwards

    Brian Edwards, Chair, Pharmaceutical Human Factors Group, CIEHF
    View Bio

    • Understanding the role human factors play in pharmaceutical manufacturing and how a novel UK group
    Is helping to drive change
    • Outlining key principles how the tools and technologies, workplace or system can be designed and adapted to suit the people who need to use it
    • How human factors underpin all quality management systems

    14:00 How to handle HPAPIs in the Small Scale HPAI Facility

    Thomas Adam

    Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer AG
    View Bio

  • GMP-Compliance and Regulatory Environment
  • Cleaning of Equipment in the Manufacturing of HPAIs 
  • Prevention of Cross-Contamination in Shared Facilities
  • Case study
  • 14:40 Afternoon Break

    15:10 Developing Effective Guidelines and Training to prevent Potential Exposure to High Potent Compounds

    Pascal Michoux

    Pascal Michoux, Vice President, Global EHS Teva api & Biologics, Teva Api Italy
    View Bio

    • Setting the expectations and the provision of clear guidelines, standards and risk management tools
    • Developing employee awareness, technical capabilities and core competencies.
    • Measuring training and programme effectiveness for continuous improvement

    17:10 Chair's Closing Remarks and Close of Day Two

    Justin Mason-Home

    Justin Mason-Home, Director, HPAPI Project Services Limited
    View Bio

    +

    FEATURED SPEAKERS

    Brian Edwards

    Brian Edwards

    Chair, Pharmaceutical Human Factors Group, CIEHF
    David Embrey

    David Embrey

    Managing Director, Human Reliability Ltd
    Fabio  Zenobi

    Fabio Zenobi

    EHS Director & QP, BSP Pharmaceuticals S.p.A.
    John Cherrie

    John Cherrie

    Professor of Human Health, Heriot-Watt University
    Justin Mason-Home

    Justin Mason-Home

    Director, HPAPI Project Services Limited
    Martin Kohan

    Martin Kohan

    Senior Occupational Toxicologist, AstraZeneca
    Mike Perry

    Mike Perry

    Director, Pharmadagio Limited
    Pascal Michoux

    Pascal Michoux

    Vice President, Global EHS Teva api & Biologics, Teva Api Italy
    Peter Marshall

    Peter Marshall

    Associate Engineering Director, AstraZeneca
    Richard Denk

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Thomas Adam

    Thomas Adam

    Head of Global Quality Assurance Chemical APIs, Bayer AG
    Ulrich Rumenapp

    Ulrich Rumenapp

    Head of Launch Preparation and Coordination, Bayer AG
    William Hawkins

    William Hawkins

    Manager Occupational Toxicology, GSK

    Brian Edwards

    Chair, Pharmaceutical Human Factors Group, CIEHF
    Brian Edwards

    Dr Edwards trained at Guy’s Hospital, London and spent 14 years in hospital medicine and clinical research before joining the UK regulatory agency which was called the Medicines Control Agency. After 5 years there, he joined a global CRO, Parexel, for six years followed by 18 months at Johnson & Johnson as a deputy qualified person for pharmacovigilance. For the last 11 years, he has been Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK. In addition he is Director of ISoP Secretariat Ltd and leads the medication error special interest group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors group.
     

    David Embrey

    Managing Director, Human Reliability Ltd
    David Embrey

    Dr David Embrey is the founder and Managing Director of Human Reliability Ltd. He holds BSc and PhD degrees in Applied Psychology from Birmingham and Aston universities. After holding Research Fellowships and lectureships at Birmingham and Aston Universities, he worked for the National Centre for Systems reliability before founding Human Reliability in 1982. During the eighties he carried out research into human reliability assessment techniques for the US Nuclear Regulatory Commission, with Brookhaven and Oak Ridge National Laboratories. Since then, he has worked on consultancy and research projects in industries including chemical processing, aviation maintenance, air traffic control, nuclear power generation, rail and marine transport, manned spaceflight and pharmacy. He was the primary author of a standard textbook on human factors in the chemical process industry: Guidelines for Reducing Human Error in Process safety for the US Center for Chemical Process Safety.
     

    Fabio Zenobi

    EHS Director & QP, BSP Pharmaceuticals S.p.A.
    Fabio  Zenobi

    EHS Director, BSP Pharmaceuticals S.p.A.
    Fabio is responsible of Environment, Health and Safety at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. He is a Pharmaceutical Chemist and has over 20 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.

    Friederike Hermann

    Head of Occupational Hygiene, Lonza
    Friederike Hermann

    Dr. Friederike Hermann is Head of Occupational Hygiene at Lonza Visp. She obtained her doctorate in the field of Analytical Chemistry with an emphasis on Element Speciation. In 2001, Dr. Hermann started as an Analytical Chemist in the Environmental Department and eventually transitioned into the field of Occupational Hygiene. She was significantly involved in the setup of high potent compound production at Lonza. She completed her Master of Advanced Studies (MAS) degree on Work and Health at the ETH Zürich and the University of Lausanne. Dr. Hermann is a certified hygienist through the Swiss Society of Occupational Hygiene. She is a member of the steering committee of COP Containment ISPE Affiliate DACH. She is also a member of the MAK Commission Switzerland and actively participates in a network of Occupational Hygienists, Physicians and Toxicologists, which form the Basel Chemical Industry (BCI). She is also a member of the Health Commission for the Lonza Visp site, which has over 3,000 employees.

    John Cherrie

    Professor of Human Health, Heriot-Watt University
    John Cherrie

    John Cherrie is Professor of Human Health at Heriot Watt University and Principal Scientist at the Institute of Occupational Medicine (IOM) in Edinburgh, UK. He has worked on several research studies involving measurement and modelling of exposure to chemicals and other environmental hazards, including testing the effectiveness of respiratory protective equipment. He is a member of the British Workplace Health Expert Committee and the Industrial Injuries Advisory Council.

    Justin Mason-Home

    Director, HPAPI Project Services Limited
    Justin Mason-Home

    Justin Mason-Home is an organic chemist and Fellow of the Royal Society of Chemistry, with extensive health, safety, environmental and chemical engineering experience in senior technical, legal and commercial aspects of the pharmaceutical, biochemical, chemical and other industries. He has held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and corporate environmental management. Mr Mason-Home has worked on many HPAPI projects for over 19 years, contributing potent compound project support advice for many years. He specialises in technically complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.

    Martin Hogan

    Managing Director , Corporate Health Ireland
    Martin Hogan

    Graduated in Medicine from University College Cork, Ireland in 1987. He is a Fellow of both the Faculty of Occupational Medicine and of the Royal College of Physicians of Ireland. Currently Full-time Occupational Medical Specialist working in Cork, Ireland. Special interest is Toxicology and the Pharmaceutical &Chemical Industry, in particular.

    Former Dean of the Faculty of Occupational Medicine of the Royal College of Physicians of Ireland. Lecturer in Toxicology in University College Cork, Ireland. Former National Specialty Director for Occupational Medicine in Ireland and Examiner for the Faculty since 2002. President of the 2018 ICOH Congress in Dublin. ICOH And Medichem Board Member for the 2018-2021 Triennium..
     

    Martin Kohan

    Senior Occupational Toxicologist, AstraZeneca
    Martin Kohan

    BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and PhD in Medical Sciences both from the Hebrew University of Jerusalem, Israel. Over 9 years of industry experience in the field of Toxicology conducting and managing over 900 hazard assessments, including calculation of exposure limits and/or determination of exposure control bands of drug substances and of their intermediates for Teva (2010 to 2018) and AstraZeneca (2018 to present). Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and Member of the UK Register of Toxicologists and of the British Toxicology Society.

    Mike Perry

    Director, Pharmadagio Limited
    Mike Perry

    Mike Perry is an independent occupational hygiene consultant and director of Pharmadagio Limited. His career within the field of potent compound safety began in 2007 when he joined the European branch of SafeBridge Consultants. Working alongside recognised industry experts for nine years, his experience at SafeBridge provided Mike with a platform for his own specialist consultancy, which he formed in 2016. His company continues to gain presence in the industry through the sharing, application and further development of his knowledge through all stages of the drug development cycle, particularly with respect to pharmaceutical exposure control and assessment strategies, containment performance verification and ongoing development of procedures for the optimisation of specialist engineering controls.

    Pascal Michoux

    Vice President, Global EHS Teva api & Biologics, Teva Api Italy
    Pascal Michoux

    Pascal Michoux is an experienced EHS Executive, with a strong business sense complemented by a solid education background in Biochemistry. He has more than 33 years of experience in API and Pharma Manufacturing in different roles and companies.
    In his carrier, he conducted multiple studies or coordination of EHS projects, developing road map to EHS excellence. Providing strategic direction to establish EHS excellence culture, using Behaviours Based Safety program and Lean Six Sigma experience to make EHS part of standard practices into daily operations.
    Since he joined Teva in 2015 to lead EHS in the Teva api and Biologics organization, he is carefully looking the HPAPI technology as part of product allocation or transfer projects, while looking to optimize the existing engineering controls.

    Peter Marshall

    Associate Engineering Director, AstraZeneca
    Peter Marshall

    Trained as a Biochemical Engineer at UCL, Peter has worked for ICI/Zeneca/AstraZeneca for 33 years, with 25 years working with
    high hazard chemicals.
    Responsibilities include global Subject Matter Expert for containment systems, Technical Lead for multiple international OSD
    developments, and support to multiple emerging market CMOs in areas of technical transfer and worker safety.
    Co-chair ISPE Containment CoP Committee 2006-9, current member. Member of Author teams for
    ‘SMEPAC’ containment system testing GPG (1st and 2nd Edns), Cross Contamination Baseline guide (RiskMAPP) (1st/2nd Edns)
    OSD Baseline Guide 3rd Edition.

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Richard Denk

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP (Sterile Product Processing) CoP. Furthermore Mr. Denk founded the PDA Expert Group about Cleaning and Cross Contamination Requirements for Biopharmaceutical Products and published this topic as PDA Paper. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

    Thomas Adam

    Head of Global Quality Assurance Chemical APIs, Bayer AG
    Thomas Adam

    Dr. Thomas Adam is currently the head of global quality assurance chemical APIs in the chemical development department of the pharmaceutical business unit of Bayer AG. He is responsible for the release of chemical APIs for clinical trials and the GMP-Quality system. He has the QA-oversight of the pilot plants and analytical development laboratories.
    Thomas holds a PhD in analytical chemistry from the University of Mainz in Germany.
    He has about 20 years of industrial experience at Bayer AG in different QC/QA-functions and a two years Post-Doc experience at Novartis, Switzerland.
    He is and was involved in many technical (transfer)-projects so as the planning and launching of the new GMP-kg lab for highly potent APIs and establishing a cleaning concept for the chemical development department.
     

    Ulrich Rumenapp

    Head of Launch Preparation and Coordination, Bayer AG
    Ulrich Rumenapp

    Dr. Rümenapp is based in Wuppertal, Germany and working within the Product Supply Pharmaceuticals, Biological Development organization, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody-drug-conjugates) to external manufacturing partners and regulatory submission and launch preparations.

    Prior to working in Development, Dr. Rümenapp was Head of Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply.

    Before it was acquired by Bayer, Dr. Rümenapp hold a similar position at Schering AG, and before that, he worked in the Production & Logistics department of Schering, where he was responsible for production aspects of in- and out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics.

    Dr. Rümenapp studied chemistry and holds a Ph.D. in biosciences. He worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.
     

    William Hawkins

    Manager Occupational Toxicology, GSK
    William Hawkins

    19 years working in toxicology with previous experience as a study director and consumer safety hazard and risk assessor. Current role; Occupational Toxicologist within the pharmaceutical industry at GSK for the last 9-years.
    Lead Toxicologist of the GSK group responsible for the compilation of integrated, scientifically relevant and compliant human safety assessments (monographs) for drug substances, intermediates and raw materials. Setting health-based exposure limits (HBEL) to assure patients and workers safety (Permitted Daily Exposure Limits (PDE), Occupational Exposure Limits (OEL).

    Sponsors

    Exhibitors

    Official Media Partner

    Key Media Partners

    Supporting Media Partners

    VENUE

    Remote UK

    United Kingdom

    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

    Short Programme 2020

    Download

    HPAPI 2019 Infographic

    Download

    Remote Access 2020

    Download

    Presentation by Frederic Le Pape, FPS

    Download

    Presentation by Fabio Zenobi-EHS, BSP

    Download

    Presentation by Charlyn Reihman, Safebridge Consultants

    Download

    Speaker interview with Justin-Mason Home

    Download

    Speaker interview Richard Denk

    Download

    Speaker interview - Brian Edwards, CIEHF

    Download

    HPAPI 2020 Brochure

    Download

    HPAPI Attendees 2019

    Download

    Workshop Programme

    Download

    Presentation by David O'Connell, PCI

    Download

    Presentation by Peter Marshall, AstraZeneca

    Download

    Presentation by Ester Lovsin, Lonza

    Download

    Presentation by Justin Mason-Home, FRSC

    Download

    Highly Potent Active Pharmaceutical Ingredients Programme

    Download

    Sponsors


    BSP Pharmaceuticals

    Sponsors
    http://www.bsppharmaceuticals.com

    BSP Pharmaceuticals S.p.A. is a CDMO (Contract Development and Manufacturing Organization), focused on the development and manufacturing of anticancer drugs with High Potency and Cytotoxic characteristic and It is specialized on formulation and manufacturing of Small Molecules and ADC products (Antibody Drug Conjugate). BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. With its state-of-the-art technology and highly skilled personnel, BSP sets out to be a valuable point of reference to serve the principal actors of the pharmaceutical field involved in research on new generation anticancer therapies. BSP clients can avoil of this integrated services: • DEVELOPMENT SERVICES • CLINICAL SUPPLY • COMMERCIAL SUPPLY BSP has been conceived starting from a basic but essential operating requirement: segregate the high potent components from the surrounding and create a system suitable to manage pharmaceutical processes. With this primary idea in mind, layouts, flows of materials and personnel, air flows have been designed to minimize the risk of contamination for the environment, for the employees and for the product that is intended for patients with low level of immune defenses. The Manufacturing plant is located in Italy, 60 kilometers southbound of Rome. A single campus extended to more than 40 acres hosts all the main buildings supporting the capacities to manage a wide range of batch sizes: 2| DEVELOPMENT LABORATORIES 3| CONJUGATION SUITES 6| STERILE SUITES with more than 170 m2 fully dedicated to production anticancer and cytotoxic drugs 1| ORAL DEPARTMENT with multiple lines suitable to manufacture Clinical and Commercial products

    Exhibitors


    Dec Group

    Exhibitors
    www.dec-group.net

    Dec Group is a leading global provider of contained powder handling systems and is recognized as a world-leading expert in process containment technologies. It has been supplying the pharmaceutical, chemical, food and cosmetic industries for more than 30 years. Headquartered near Lausanne, Switzerland, Dec Group has a global presence with subsidiaries and agents in more than 30 countries including subsidiaries in the UK, Ireland, Germany, Poland, India, China and the USA. In excess of 600 companies worldwide have successfully integrated more than 9000 Dec systems into their production sites. These include a wide range of patented products that enhance safety, hygiene, containment, reliability and productivity in powder handling. Dec offers innovative approaches across the range of powder handling and process containment applications, including transfer, micronizing, filling/emptying, sampling, blending, dosing, aseptic solutions, milling, isolators and advanced cleaning (CIP/SIP) features.

    Media Partners


    Speciality Chemicals Online

    Official Media Partner
    https://www.specchemonline.com/

    Published continuously since 1981, Speciality Chemicals Magazine is the leading monthly magazine dedicated to covering business, markets and technology in the fine and speciality chemicals industries world-wide. We have over 50,000 readers and a calendar of features covering the full gamut of applications, including pharmaceuticals, agrochemicals, cosmetics and personal care, biobased chemicals, surfactants, biocides and much more.

    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

    Media Partners


    International Pharmaceutical Industry

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

    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


    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.


    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.


    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.


    Mednous

    Supporting Media Partners
    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


    Pharma network magazine

    Supporting Media Partners
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    ASD MEDIA

    Supporting Media Partners
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
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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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