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Live eLearning - PDA 731 Practical Application of Risk-Based GMP & Quality Principles to Clinical Development of ATMPs

Jun 10, 2020
10:00 AM
-
5:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Closed

Overview

There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), both in the EU and US. 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 ATMPs, 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 No. 81: Cell-Based Therapy Control Strategy, will be discussed.

Agenda

  • Wednesday, June 10, 2020

    Welcome and Introduction


    Overview of the ATMP Landscape (1.5 hours)

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

    Break (15 minutes)

    ATMP GMP and Quality Risk Consequences (1.5 hours)

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

    Break (1 hour)

    Regulatory Authority Expectations During Clinical Development (1.5 hours)

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

    Break (15 minutes)

    Industry Practice in Applying Risk-Based Considerations to ATMPs (1.5 hours)

    • PDA Technical Report No. 81
    • Lessons learned from industry practice

    End of Training Course

Trainers

John Geigert
John Geigert
Biopharmaceutical Quality Solutions

Learning Objectives

  1. Identify the GMP and quality similarities and differences between protein medicinal products and ATMPs
  2. Explain how to apply a risk-based approach to the manufacturing and quality control of ATMPs
  3. Explain and justify the importance and underlying GMP and quality principles for ATMPs during clinical stages of development

Who Should Attend

This training course is intended for professionals who are involved in the manufacturing, quality and GMP compliance of ATMPs during clinical stages of development.

Departments
  • Regulatory Affairs
  • Research and Development
  • Quality Compliance
  • Manufacturing
  • Quality Assurance Operations
  • Technical Operations
  • Training

Roles
  • Auditor/Inspector
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer
  • Director

Registration Fees

Closed
Registration Type Price
Member $600
Non-member $600
Gov't/Health Auth./Academic $600

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