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Parenteral Drug Association Connecting People, Science and Regulation ®

CMC Regulatory Compliance for Biopharmaceuticals

Sep 05 - Sep 06, 2019 |
Sep 06, 2019 |
Sheraton Munich Arabellapark Hotel | Munich, Germany
  • Education
  • Europe
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Biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. Companies clearly understand the critical importance of their human clinical study strategy, but frequently, the development of a strategy for Chemistry, Manufacturing & Controls (CMC) is an afterthought. Add the frequent lack of CMC regulatory compliance experience in some companies, coupled with the complexity of the biological manufacturing processes and products, and this can be a recipe for disaster.

This course will provide insights and practical guidance for the CMC teams to develop an acceptable cost-effective CMC regulatory compliance strategy for biopharmaceuticals from early clinical stage development through market approval. The course emphasis will include FDA, EMA and ICH guidance.

Who Should Attend

This course is designed specifically for those involved in or interested in the manufacture and control and CMC regulatory issues of biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA/ QC, Regulatory Affairs, Manufacturing and Process Development personnel.

Learning Objectives

Upon completion of this course, you will be able to:
  • Explain the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move your products through clinical development into the marketplace
  • Explain the importance and underlying principles for CMC regulatory compliance of biopharmaceuticals and how this leads regulatory agencies to have different CMC regulatory requirements for biotech products compared to pharmaceuticals of chemical origin.

Instructor

John Geigert, PhD, BioPharmaceutical Quality
John Geigert is President of BioPharmaceutical Quality Solutions, which for the last 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry. He has over 40 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe. John Geigert has served on the PDA Board of Directors, currently chairs the PDA Biopharmaceutical Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics 2nd Edition, and has written extensively for RAPS Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series)), Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series). John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.

Wednesday, 05 September 2019

9:00
Welcome and Introduction


CMC Regulatory Challenges for Biopharmaceuticals are Different

9:10
Painting the Terminology Landscape: Biologic, specified biologic, biopharmaceutical, biosimilar, CBER, CDER, EMA, ...


10:30
Coffee Break

11:00

  • Understanding the CMC Differences of Biopharmaceutical Regulation between FDA and EMA
  • Biopharmaceuticals are not Chemical Drugs – Regulatory Compliance Consequences of the four Major CMC Differences

12:30
Lunch Break

How to Develop an Effective Corporate CMC Risk-Managed Control Strategy for Biopharmaceuticals

13:30

  • Three Major Forces that Shape the CMC Regulatory Compliance Strategy of all Biopharmaceuticals/li>
  • Five Key Elements of an Effective Corporate CMC Regulatory Compliant Strategy

15:00
Coffee Break

15:30

  • Impact of the Quality by Design (QbD) on Biopharmaceutical CMC Strategy
  • Necessity of a Clinical Phase - Appropriate CMC Regulatory Compliance Strategy

17:00
End of Day 1

Thursday, 06 September 2019

Applying a CMC Risk-Managed Control Strategy to the Biopharmaceutical Manufacturing Process

9:00

  • Four Myths about Biopharmaceutical Starting Material – the Master Cell Bank
  • Necessity of Confirming Clonality and Genetic Stability

10:30
Coffee Break

11:00

  • Importance and Limitations of small-scale Studies for Biopharmaceuticals
  • Clinical Phase - Appropriate Control of the Biopharmaceutical Manufacturing Process
  • Formulation and Container-Closure Challenges for Biopharmaceuticals – Impact of Components on the Biopharmaceutical (e.g., protein aggregation) and Impact of the Biopharmaceutical on Components (e.g., glass delamination)

12:30
Lunch Break

Challenge of Managing Manufacturing Process Changes and Demonstrating Biologic Product Comparability – Not an Easy Task!

13:30

  • Need for Risk-based, Sequential and Clinical Phase - Appropriate Comparability Studies
  • Demonstrating Biologic Product Comparability – Justifying CMC Differences

15:00
Coffee Break

15:30

  • “Comparability Protocol” and “Post Approval Change Management Protocol”
  • Extreme Comparability of Biosimilars: Limitations of CMC Comparison, Fingerprinting – CMC Biosimilarity Successes and Failures

17:00
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

1595 Euro

Contact

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

More information coming soon.

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

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4525

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