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2020 ATMPS

Practical Application of Risk-Based GMP & Quality Principles to Clinical Development of ATMPs

Jun 23, 2020
Brussels, Belgium

There has been a surge in clinical development of Advanced Therapy Medicinal Products (ATMPs), also known as Cellular and Gene Therapy (CGT) Products in the USA.

  • Education
  • 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

  • Tuesday, 23 June 2020

    9:00
    Welcome & Introduction


    9:10
    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

    10:30
    Coffee Break

    11:00
    ATMP GMP and Quality Risk Consequences

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

    12:30
    Lunch Break

    13:30
    Regulatory Authority Expectations During Clinical Development

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

    15:00
    Coffee Break

    15:30
    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

Additional Information

  • Learning Objectives

    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

    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.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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Travel

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Tangla Hotel Brussels

Avenue Emmanuel Mounier 5
Brussels, Belgium
Phone: +32 2775 2508

Tangla Hotel Brussels
  • Accommodations

    Hotel Website

    Situated in Brussels, 5 km from the European Parliament, Tangla Hotel Brussels boasts an Oriental design respecting Feng-Shui rules. Free WiFi is offered. Every room at this hotel is air conditioned and is equipped with a flat-screen TV. Certain rooms feature a seating area for your convenience. You will find a coffee machine and a kettle in the room. The rooms have a private bathroom.
    The hotel also features an all-dining restaurant, a bar lounge and several meeting rooms.

    Brussels Grand Place is 6 km from Tangla Hotel and the nearest metro station is 700 m away offering a direct connection to Brussels Central Station. The nearest airport is Brussels Airport, 5 km from Tangla Hotel Brussels.

    PDA Europe has reserved a limited number of rooms until the 29th April 2020
    Single Superior Room € 160 per night*
    Double Superior Room Upon Request*

    *Rates are per room and night, including the following services and benefits:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
    • Complimentary Airport Shuttle available upon request
  • Amenities

How to Get Here

By Air

Nearest Airport: Brussels - Zaventem Airport - BRU
Airport Phone:
+32 2 753 77 53

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Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €895

All fees given in Euro and excluding VAT (21%)

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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