PDA Europe Virtual Training Course - CMC Regulatory Compliance for Biopharmaceuticals

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Program Highlights

Biopharmaceuticals for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars), but also bispecific antibodies and antibody drug conjugates (ADCs), and now gene therapy (genetically engineered viruses and cells) products.

These biopharmaceuticals are being manufactured by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory compliance 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 CMC is often 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 training course will provide insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceutical manufacturing across the diverse product types from early clinical stage development through market approval. The training course emphasis will focus on FDA, EMA and ICH guidance.

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.

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Monday, 12 October 2020

Welcome and Introduction

CMC Regulatory Compliance is Challenging for Biopharmaceuticals
Discussion of the increasing diversity of biologics, and the regulatory authority systems in place to control these evolving manufacturing processes and products


Risk-Managed CMC Regulatory Compliance Strategy
Five (5) key design elements of an effective risk-managed ‚minimum CMC regulatory compliance continuum‘ for biopharmaceuticals

End of Day 1

Day 2

Tuesday, 13 October 2020

Applied Risk-Managed CMC Regulatory Compliance Strategy
Detailed roadmap from starting material to drug product for a monoclonal antibody; General roadmap from starting material to drug product for a gene therapy virus


Demonstrating Comparability After Manufacturing Process Changes
Three (3) key design elements of an effective risk-managed comparability exercise for biopharmaceuticals

End of Training Course

Agenda is subject to change.

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