PDA Europe Virtual Training Course - Practical Application of Risk-Based GMP & Quality Principles to Clinical Development of ATMPs

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Note   In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 – 2 weeks in advance. Hard copies of course notes will no longer be provided to participants.

There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), both in the EU and the USA. Many start-up companies, and now even large biopharmaceutical companies, are planning or have already entered into manufacturing these genetically engineered viruses and/or human cell products for clinical studies.

While the ground rules for Good Manufacturing Practices (GMPs) and Quality of recombinant protein and monoclonal antibody manufacturing and control are well established, for ATMPs these are still under development.  ATMP manufacturing and control presents unique GMP and Quality challenges, such as the heightened concern about the safety/variability of the starting materials, the quality of the raw materials added during processing, the need to protect against adventitious agent contamination throughout the entire manufacturing cycle, the limited analytical methods available to characterize these advanced therapy products, and the reality that the administered clinical medicinal product is a complex living organism. In addition, the expedited pace of clinical studies for these ATMPs places enormous pressure on the need to also rapidly develop and enhance the manufacturing process control systems.

Patients in these clinical development programs need to be protected by common sense GMPs and Quality principles. The available EMA/FDA regulatory authority guidance documents for ATMPs will be thoroughly examined. In addition, the core, risk-based principles presented in PDA’s 2018 Technical Report 81 ‘Cell-Based Therapy Control Strategy’ will be discussed.

Upon completion of this course, you will be able to:

  • Explain the importance and underlying GMP and Quality principles for manufacturing, control and compliance of ATMPs during clinical stages of development
  • Appreciate the GMP and Quality similarities and differences between protein medicinal products and ATMPs
  • Appropriately apply phase-appropriate GMPs and Quality Principles to the clinical development of ATMPs

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
Melanie Decker
[email protected]
Registration Customer Care

Standard Registration

Member Price

€400

GovernmentMember Only

€400

Health AuthorityMember Only

€400

Early Career ProfessionalMember Only

€400

StudentMember Only

€400

AcademicMember Only

€400

Non-Member

€400

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Wednesday, 17 June 2020

10:00
Welcome & Introduction

Overview of the ATMP Landscape

  • Defining the critical terminology: ATMP, CAT, OTAT, RMAT, etc.
  • How the diversity of ATMPs challenge the application of GMP and Quality
Coffee Break

ATMP GMP and Quality Risk Consequences

  • Major differences between gene / cell-based medicines and protein-based medicines
  • Necessity of a risk-based approach
Lunch Break

Regulatory Authority Expectations During Clinical Development

  • EMA guidelines and risk-based considerations for ATMPs
  • FDA guidances, comparison to EMA
Coffee Break

Industry Practice in Applying Phase-Appropriate GMPs and Quality to ATMPs

  • PDA Technical Report 81
  • Lessons learned from industry practice

17:30
End of Training Course

Agenda is subject to change.

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