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2020 ATMPS

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

Jun 17, 2020
10:00 AM
-
5:30 PM
| Central Europe Standard Time
Online
  • Virtual
  • Education
  • Online
  • Europe

Overview

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.

Agenda

  • 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

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions

Learning Objectives

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

Who Should Attend

This course is designed for those involved or interested in the manufacturing, quality and GMP compliance of ATMPs during clinical stages of development, including Senior Managers, Directors and Managers/Supervisors, QA/QC, Regulatory, Manufacturing and Process Development personnel.

Registration Fees

Register Now
Registration Type Price
All Participants €400

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