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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.
With an emphasis on product development challenges and regulatory expectations in the US, Europe and other highly regulated regions, this workshop provides an in-depth study of chemistry, manufacturing and control (CMC) product development requirements and best practices associated with biologics, biosimilars.
Specifically designed for RA/QA professionals, managers and scientists responsible for biopharmaceutical CMC development and preparation of dossiers, this in-depth discussion will take a regulatory approach to the technical issues that arise during biologic product development and registration.
Topics will include:
December 7, 2022 - March 26, 2023: Early Bird $1135.00 member | $1340.00 nonmember
March 27, 2023 – April 27, 2023: Regular $1340 member | $1570.00 nonmember
At the conclusion of this workshop, participants should:
This program will benefit early, mid-career, and senior subject matter experts (SMEs) and regulatory professionals in CMC working in development, registration and post-approval lifecycle management for biological products. There are no prerequisites for participation. It is recommended that Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges be taken prior to this course for early career SMEs.
Day 1 (9:00 am – 4:00 pm EDT)
Day 2 (9:00 am – 4:00 pm EDT)
The agenda may vary based on changing requirements.
Patricia Cash, PhD, Independent 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 PhD 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 experience in the biologics and 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 28 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.
Erica Shane, Ph.D., Independent Biotechnology Consultant
Dr. Shane is senior biotechnology professional with over 25 years of experience in the biotechnology and pharmaceutical industry with in-depth experience in vaccine and monoclonal antibody process development, clinical manufacturing and technology transfer to internal and external partners. She is currently an independent consultant focused on CMC. She was previously Vice President, Process Development at Novavax where she had responsibility for all process and analytical development activities. In addition, she provided oversight of technology transfer, process validation and technical support for manufacturing. Dr. Shane received her doctorate degree from Carnegie Mellon University, and her bachelor's degree from the Massachusetts Institute of Technology, both in chemical engineering.
RAPS HQ5635 Fishers LaneTerrace LevelRockville, MD 20852
Parking: Parking will be free at RAPS HQ with a validated ticket. Please make sure to bring your parking ticket to registration to validate parking. Overnight parking is not allowed.
Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr 1750 Rockville Pike Rockville, Maryland, 20852-1699, USA Telephone: (301) 468-1100 Hotel Website Distance to RAPS HQ: .8 miles Directions to RAPS HQ
EVEN Hotel Rockville 1775 Rockville Pike Rockville, MD 20852 Telephone: (301) 881-3836 Hotel Website Distance to RAPS HQ: .7 miles Directions to RAPS HQ
RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test will not be permitted to attend.
RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.
Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site in St. Paul, you will reconsider your participation at the event. To help ensure your personal safety and comfort, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.
All cancellation requests must be submitted in writing to email@example.com. Cancellation requests received by Sunday; 11 September 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 11 September 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.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email firstname.lastname@example.org with the event title, name of the original registrant and the contact information for the new attendee.
Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.
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