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Parenteral Drug Association Connecting People, Science and Regulation ®

Practical Application of Phase- Appropriate GMP & Quality Principles to Clinical Development of ATMPs

Jun 06 - Jun 06, 2019 |
Jun 06, 2019 |
Radisson Blu Hotel Lietuva | Vilnius, Lithuania
  • Education
  • Europe
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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. Many startup companies, hospitals, universities, and now even large biopharmaceutical companies, are planning or have already entered into manufacturing these genetically engineered virus and 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 the ATMPs these are still under development.

ATMP manufacturing and control presents unique GMP and Quality challenges, such as the heightened concern about the safety and consistency of the starting material, the safety and quality of the raw materials added during processing, the need to protect against adventitious agent contamination during the entire manufacturing cycle, the limitations of the analytical methods available to characterize these virus and cell products, and the reality that the administered clinical medicinal product is a complex living organism.

Patients in these clinical development programs need to be protected by common sense GMPs and Quality. The available regulatory authority guidance documents (both EMA and FDA) for ATMPs will be thoroughly examined. In addition, the core principles presented in PDA’s 2016 Technical Report 56 ‘Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Bulk Drug Substance (API)’ will be adapted to 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.

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

Instructors

John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions
John Geigert has been a consultant for the past 15 years, specializing in CMC regulatory strategy for the biopharmaceutical industry. He has held senior leadership positions in industry as Vice President of Quality for both IDEC Pharmaceuticals Corporation and Immunex Corporation. He has been a major participant in regulatory approvals for six biopharmaceutical products now commercially available in the U.S. and in Europe, and has over 40 years of experience in the biologic and biopharmaceutical industry. John obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University. He has served as a member of the PDA the Board of Directors, and is currently the chair of the PDA Biopharmaceutical Advisory Board. He is US Regulatory Affairs Certified (RAC) by the Regulatory Affairs Certification Board (RACB).

Thursday, 6 June 2019

9:00
Welcome & Introduction


9:10
Understanding the Basics

  • Painting the terminology landscape: ATMP, HCT/P, GMP, Quality System, etc.
  • Introduction to the risk-based, phase-appropriate GMP and Quality approach

10:30
Coffee Break

11:00
Major Differences, and the Regulatory Consequences

  • Viruses/cells are not biologic proteins
  • GMP and Quality consequences of the differences between gene / cell-based medicines and protein-based medicines

12:30
Lunch Break

13:30
Regulatory Authority (EMA/FDA) Expectations

  • Regulatory authority risk-based considerations to ATMP GMPs and Quality
  • Regulatory authority guidances for a phase-appropriate approach to ATMP GMPs
    and Quality

15:00
Coffee Break

15:30
Industry Practice in Applying Phase-Appropriate GMPs and Quality to ATMPs

  • Adapting PDA Technical Report 56 as a model for phase-appropriate ATMP GMPs
    and Quality
  • Lesson learned from industry

17:30
End of Training Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

895 Euro

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

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Radisson Blu Hotel Lietuva
Konstitucijos pr. 20,
LT-09308,Vilnius
Lithuania
Tel: + 370 5272 6272
Hotel Website

The Radisson Blu Hotel Lietuva, in Vilnius, stands on the banks of the River Neris. The hotel is in the heart of Lithuania’s capital, near rich historic sites such as the Old Town and Vilnius Cathedral. Old Town is also the place for shopping. Wander around the cobbled streets and explore the wide range of stores and markets. You’re close to an array of transport options, including bus and train station, while the airport is just 9 kilometers away.

The hotel’s Riverside restaurant serves a varied breakfast buffet and a selection of international and Scandinavian dishes. Guests can visit the Skybar, located on the 22nd floor and offering views of the Old Town.

PDA Europe has reserved a limited number of rooms until the 15th April 2019.
Book your room for the PDA Group Rate.

Single Room € 120 per night*
Double Room € 135 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Vilnius Airport– VNO
Airport Phone: +370 612 44442

Hotel direction: 9 km

Parking

  • Private Parking at the hotel, upon request.

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

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https://store.pda.org/Meetings/Login.aspx?ID=4740

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