Pharmaceutical Development of ATMPs

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

30-31 Mar 2020

& 5-6 Oct 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

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 AMTP.

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 Day One

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
Understanding clinical trials
  • EU clinical trial requirements
  • The US IND
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
Risk-based approach for ATMPs
  • Examining 3.2.A Adventitious Agents
  • Level of data required EU/US

Programme Day Two

GMP for ATMPs
  • What is required: examine the major differences between GMP for ATMPs and conventional therapeutics
  • 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 Investigational Medicinal Product Dossier (IMPD)
  • Terms and definitions
  • Guidance on IMPD content for ATMPs
  • Data requirements for first-in-human vs later clinical trials

Presenter

Andrew Willis

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

30-31 Mar 2020
30-31 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
5-6 Oct 2020
5-6 Oct 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Astellas Pharma Europe B.V. (EU 10)
  • Aummune
  • Becton, Dickinson and Company
  • Biomarin Pharmaceuticals Inc.
  • CHI
  • CSL Behring GmbH
  • Dorian Regulatory Affairs BV
  • ELECTS
  • GAMMADELTA THERAPEUTICS
  • Genzyme Polyclonals
  • Gilead Sciences International Ltd
  • GSK
  • Hookipa Biotech AG
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MeiraGTx
  • myTomorrows
  • Novo Nordisk A/S
  • Saudi Food and Drug Authority
  • University of Brighton
  • University of Zurich
  • URGO Ltd

Great and really interesting.

Heloise Armand, Quality Director, Genzyme Polyclonals

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

Very good!

Marie-Charlotte Royer, Quality Engineer, Urgo RID

Great depth of experience. Well presented, very intense and in-depth material.

Elizabeth Watson, Scientific Writer, Hookipa Biotech