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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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:
15 November 2022 – 2 January 2023: Member $825.00 |Nonmember $970.002 January 2023 – 2 Feburary 2023: Member $970.00 |Nonmember $1,150.00
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 Thursday, 2 February 2023
9:00 am – 9:30 am
Introduction to Biopharmaceuticals
9:30 am – 10:00 am
Biologics Product Characteristics and Regulatory Implications
10:00 am – 10:30 am
CMC Regulation and Guidances
10:30 am – 10:45 am
10:45 am – 11:30 am
Quality by Design, ICH 8-12
11:30 am – 12:00 pm
Clinical Phase - Appropriate CMC
12:00 pm – 1:00 pm
1:00 pm – 1:30 pm
Introduction to eCTD
1:30 pm – 2:15 pm
eCTD Strategy S.1
2:15 pm – 2:30 pm
2:30 pm – 3:00 pm
eCTD Strategy S.2 Upstream
3:00 pm – 3:30 pm
eCTD Strategy S.2 Downstream and Formulation
3:30 pm – 4:00 pm
Break out - Review of CRL
Day 2 – Friday, 3 February 2023
9:00 am – 10:00 am
eCTD 3.2.S.3 Characterization and Impurities
eCTD 3.2.S.4 Control of DS
10:45 am – 11:45 am
eCTD 3.2.S.4.3 and 3.2.S.5 through 7
11:45 am – 12:00 pm
Breakout Session - Review of CRL part 2
1:00 pm – 1:15 pm
Report Back from Review of CRL part 2
1:15 pm – 1:45 pm
Drug Product Considerations
1:45 pm – 2:15 pm
Appendices and Adventitious Agents
2:30 pm – 3:30 pm
Comparability and Biosimilars
Question and Answer
***Agenda is subject to change
Patricia Cash, PhDIndependent Biotechnology Consultant
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 QuinnBiologics Regulatory Consultant
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.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. Cancellation requests received by Thursday; 13 October 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 13 October 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.
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