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Pharmaceutical Development of ATMPs Training Course
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Details
Course overview
This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).
Industry expterts will cover the regulatory landscape and the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. The differences between GMP for ATMPs and conventional therapies will be discussed, as will the requirements for clinical trials and the preparation of the IMPD. Advice on the specific transportation requirements of these products will also be addressed.
This programme will be of benefit to all those involved with or considering developing an ATMP.
Benefits of attending:
- Understand the GMP requirements for clinical trials in US and Europe
- Gain a practical insight into other markets
- Determine critical quality attributes
- Develop a successful QC strategy
- Examine the major differences between GMP for ATMPs and conventional therapies
- Overcome potential pitfalls when manufacturing cells
- Discuss multi-manufacturing sites for autologous products
- Consider stability issues
- Examine risk analysis for biological materials and understand Annex 16
- Gain an introduction to GMO approval requirements
This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.
Who should attend?
- R&D personnel involved in research on cell or gene-based therapies
- Managers involved in the development and manufacture of ATMPs
- Quality assurance and quality control personnel responsible for quality aspects of ATMPs
- GMP managers responsible for implementing GMP in ATMP manufacture
- Regulatory personnel involved in inspections of ATMPs
Programme
Introduction to ATMPs
- Definition of ATMPs and associated terms
- Classification of ATMPs
The regulatory landscape
- Examining the European regulatory landscape for ATMPs – detailed analysis of existing regulation 1394/2007
- Considering factors lying outside of the regulation’s scope, e.g. combination products
- Links to related directives, eg Tissues and Cells Directives (2002/98/EC and 2004/23/EC); Medical Device Directive (93/42/EEC) and forthcoming regulation
Strategic considerations
- Opportunities to meet with regulators to maximise approval chances
- ATMP-specific options in the EU: certification procedure, risk-benefit approach
- Accelerated access opportunities in EU and US
- Understanding breakthrough status/PRIME
Insight into global regulations and requirements
- Examining key markets including Europe, US and Japan
- Evaluate the regulatory differences between regions to help you build a strategic approval route
- GMP requirements at Phase I in US and Europe – ramifications for your product
Overcoming quality challenges
- Overview of frequent quality concerns
- Potency assay development
- Determining critical quality attributes
- Developing a successful QC strategy for short-shelf-life product
- QP release: timing and logistical challenges for ATMPs
Understanding clinical trials
- EU clinical trial requirements
- The US IND
Risk-based approach for ATMPs
- Examining 3.2.A Adventitious Agents
- Level of data required EU/US
GMP for ATMPs
- What is required: examine the major differences between GMP for ATMPs and conventional therapies
- Overcoming potential pitfalls when manufacturing cells
- Current GMP interpretations
- Multiple manufacturing sites for autologous products
- Point-of-care preparation devices
Delivery and shipping
- Considering stability issues
- Challenges in transporting cell therapies/cryopreservation
- Preparation on site
Preparation for clinical trial
- Optimising materials for regulatory compliance – vendor qualification
- Risk analysis for biological materials
- The comparability concept and its importance in preparing for clinical trials
- Introduction to GMO approval requirements
Practical considerations for the IMPD
- Terms and definitions
- Guidance on IMPD content for ATMPs
- Data requirements for first-in-human vs later clinical trials
Presenters
Alison Wilson (More...)
Alison Wilson is an Independent Regulatory Affairs Consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.
Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.
She is now Principal Consultant at CellData Service who provide strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. She has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.
Andrew Willis (More...)
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.
Book now
Book now
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5-6 Oct 2020 Live webinar |
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5-6 Oct 2020 Live webinar |
GBP 1,299.00 EUR 1,859.00 USD 2,098.00 + VAT @ 20.00% |
Enrol now Limited places to attend Live webinar |
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22-23 Mar 2021 Live webinar |
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22-23 Mar 2021 Live webinar |
GBP 1,099.00 EUR 1,579.00 USD 1,786.00 Until 8 Feb 21* |
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to attend Live webinar |
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29-30 Mar 2021 Face-to-face, (venue not yet confirmed) |
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29-30 Mar 2021 Face-to-face (venue not yet confirmed) |
GBP 1,299.00 EUR 1,819.00 USD 2,026.00 Until 15 Feb 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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4-5 Oct 2021 Live webinar |
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4-5 Oct 2021 Live webinar |
GBP 1,099.00 EUR 1,579.00 USD 1,786.00 Until 23 Aug 21* |
Enrol now
to attend Live webinar |
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11-12 Oct 2021 Face-to-face, (venue not yet confirmed) |
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11-12 Oct 2021 Face-to-face (venue not yet confirmed) |
GBP 1,299.00 EUR 1,819.00 USD 2,026.00 Until 30 Aug 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
Customised in-house training
We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.
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Previous customers include...
- Amniotics AB
- Astellas Pharma
- Astellas Pharma Europe B.V. (EU 10)
- Aummune
- Becton, Dickinson and Company
- Biomarin Pharmaceuticals Inc.
- CHI
- CSL Behring GmbH
- Dorian Regulatory Affairs BV
- ELECTS
- Erasmus Medical Center Rotterdam
- Gammadelta Tx
- Genzyme Polyclonals
- Gilead Sciences International Ltd
- GSK
- Hookipa Biotech AG
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- MeiraGTx
- myTomorrows
- Novo Nordisk A/S
- Sakk
- SARQ Pharma Ltd
- Saudi Food and Drug Authority
- University of Brighton
- University of Zurich
- URGO Ltd
“I liked the course and have already recommended it to my colleagues. The content was very interesting, a lot was covered, and it was really convenient to read everything again at home and have some kind of "handbook" to look into. Both speakers were excellent and useful and clear answers were always given. They always tried to include all attendees and address their specific working areas during the course, which was really great.”
Lisa Grabner, Quality Manager Projects, University of Zurich, Oct 19
“I think Andrew Willis was very entertaining. and had good answers. Maybe even more examples from real life would be good.”
Ida Kjær, QA Professional, Novo Nordisk A/S, Apr 19
“Very good! ”
Marie-Charlotte Royer, Quality Engineer, Urgo RID, Apr 19
“Great and really interesting.”
Heloise Armand, Quality Director, Genzyme Polyclonals, Apr 19
“Great depth of experience. Well presented, very intense and in-depth material. ”
Elizabeth Watson, Scientific Writer, Hookipa Biotech, Oct 18