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PDA Europe Virtual Training Course - CMC Regulatory Compliance for Biopharmaceuticals

Oct 12 - Oct 13, 2020
3:00 PM
6:15 PM
| Central Europe Standard Time
  • Virtual
  • Education
  • Online
  • Europe


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.


  • Day 1
  • Day 2
  • 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

  • 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


John Geigert
John Geigert
Biopharmaceutical Quality Solutions

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.

Who Should Attend

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

Registration Fees

Register Now
Registration Type Price
All Participants €800

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