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Biologics CMC: Future Trends, Current Trends and Regulatory Challenges

12.0
RAC Credits
Tuesday, 19 January 2021 (9:00 AM) - Wednesday, 20 January 2021 (4:00 PM) Eastern Time (US & Canada)
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/Deadlines:
6 November 2020— 17 December 2020 $800 Member | $900 Nonmember
18 December 2020— 18 January 2021 $900 Member | $1000 Nonmember
 
Objectives:
    After this program, participants will…
    • Be familiar with various types of biologic products and their structural/functional characteristics
    • Be able to distinguish phase-appropriate regulatory agency expectations associated with biologics characterization, development, production, and testing
    • Be familiar with best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biological products
    • Be familiar with Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products
    • Be able to 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.
 
Agenda

Day 1
Morning
9:00-9:30 – Introduction to biopharmaceuticals
9:30-10:00 – Biologics product characteristics and regulatory implications
10:00-10:30 - CMC regulation and guidances
10:30-10:45 – Break
10:45-11:30 - Quality by Design, ICH 8-12
11:30- 12:00 – Clinical Phase-Appropriate CMC
12:00-1:00 lunch
Afternoon
1:00-1:30 – Introduction to eCTD
1:30 - 2:15 – eCTD Strategy S.1
2:15-2:30 - Break
2:30-3:30 - eCTD Strategy S.2 Upstream
3:30-4:00 – Break out - Review of CRL
4:00-4:30 – eCTD Strategy S.2 Downstream and Formulation, questions and answers

Day 2
Morning
9:00-10:00 – eCTD 3.2.S.3 Characterization and Impurities
10:00-10:45 – eCTD 3.2.S.4 Control of DS
10:45-11:00 – Break
11:00 – 11:30 – eCTD 3.2.S.4.3 and 3.2.S.5 through 7
11:30 - 12:00 – Breakout session
12:00-1:00 lunch
Afternoon
1:00 – 1:30 - Drug Product considerations
1:30 – 2:30 - Appendices and Adventitious Agents
2:30 - 3:00 – Comparability and Biosimilars
3:00 – Questions and answers

Speakers:
Patricia Cash, PhD, Independent Biotechnology Consultant
Dr. Patricia W. Cash, Ph.D. is a senior leader with over 30 years of 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, Biologics Regulatory Consultant
Joe Quinn is an independent Regulatory Affairs Consultant with 35 years of 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 raps@raps.org.
If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.
 
Program Contact:

Amy Heath 
Manager, Education Program Development 
Regulatory Affairs Professionals Society®
Tel: (301) 388-8376 
Email: aheath@raps.org 
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA