Skip To The Main Content
2020 ATMPS

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

Jun 23, 2020
Brussels, Belgium

  • Education
  • Europe

left to register


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.


  • Tuesday, 23 June 2020

    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

    End of Training Course


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.

Got a Question? We have answers

Contact Us


PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

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*

    You can book your Hotel Accomodation here!

    *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

By Car

More information coming soon.

Other Options

More information coming soon.


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.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information


Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events


Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially