SOLD OUT - Biologics CMC: Future Trends, Current Trends and Regulatory Challenges - April 2021

RAC Credits
Virtual Programs Virtual Programs
Tuesday, 13 April 2021 (9:00 AM) - Wednesday, 14 April 2021 (4:00 PM) Eastern Time (US & Canada)

This workshop is currently sold out; another session is offered 2-3 November 2021:

Ensure your manufacturing process consistently produces safe and effective biologics.

All stages of the drug development life cycle require the proper adherence to chemistry, manufacturing and control (CMC) regulatory requirements. Join this two-day workshop for an introductory overview of CMC requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other highly regulated regions.

The class is designed to orient professionals, managers and scientists responsible for biopharmaceutical CMC activities in the preparation of dossiers as well as an overview of some of the technical issues that must be addressed in biologic product development, registration, and lifecycle management.

Topics will include:
• Biological product characteristics
• CMC regulations and guidance applicable to biologics
• Quality by Design
• Adventitious agents risk management
• Source material, cell & seed banks
• Upstream and downstream processing
• Formulation and final product production
• Characterization and testing
• Demonstrating comparability

Pricing Amounts & Deadlines

16 November 2020 – 15 March 2021: Early Bird $800 Member |  Nonmember $900
16 March 2021 – 12 April 2021: Regular: Member $900 | Nonmember $1000 


• Identify various types of biologic products and their structural/functional characteristics
• Distinguish phase-appropriate regulatory agency expectations associated with biologics characterization, development, production, and testing
• Summarize best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biological products
• Describe Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products
• Translate an effective biologics CMC strategy into effective regulatory submission content for biological products, including all sections of module 2 and 3 of the CTD.

Who Should Attend? 

This program will benefit mid-career regulatory professionals in CMC working in development, registration and post approval lifecycle management for biologic/biosimilar products. CMC SMEs will gain value in learning the regulatory implications of product development. There are no prerequisites for participation.


Day 1 

  • Introduction to biopharmaceuticals
  • Biologics product characteristics and regulatory implications
  • CMC regulation and guidances
  • Quality by Design, ICH 8-12
  • Clinical Phase-Appropriate CMC
  • Introduction to eCTD
  • eCTD Strategy S.1
  • eCTD Strategy S.2 Upstream
  • Review of CRL
  • eCTD Strategy S.2 Downstream and Formulation, Questions

Day 2 

  • eCTD 3.2.S.3 characterization and Impurities
  • eCTD 3.2.S.4 control of DS
  • eCTD 3.2.S.4.3 and 3.2.S.5 through 7
  • Drug product considerations
  • Appendices and adventitious agents
  • Comparability and biosimilars


Patricia Cash

Patricia Cash, PhD

Dr. Patricia W. Cash, Ph.D. is a senior leader with over 30 years experience in all aspects of analytical development, specification setting, quality control testing and preparing and defending regulatory filings. She is currently an independent consultant. She previously was senior director in the Analytical Biochemistry Department at MedImmune, where her group was responsible for developing and implementing analytical methods used for characterization, lot release, and in-process testing of all protein projects at various stages of development. She holds a Doctorate of Philosophy and a Masters of Science degree in Chemistry from Rutgers University, Bachelor of Arts degree in Chemistry from The King’s College, and a Masters of Business Administration, Technology Management from University of Phoenix.

Joseph Quinn

Joseph Quinn

Joe Quinn is an independent Regulatory Affairs Consultant with 35 years experience in the biologics/vaccine industry, including assignments in Quality Control, Research, Product Development & Scale-Up, Bioanalytical Development & Validation, Project Management, and Regulatory Affairs. Joe was employed by Sanofi Pasteur for twenty-eight years, most recently in the position of Senior Director, Head of North American Regulatory Affairs. Joe teaches graduate-level courses in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance program. He holds a Master of Science degree in Quality Assurance and Regulatory Affairs, Master of Science degree in Chemistry, Bachelor of Science degree in Biochemistry, and Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to


If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at

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