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This event is sold out. The next instance of Biologics CMC: Phase-Appropriate Product Development will be held on 13 & 14 July 2021. Click here to learn more.
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 controls (CMC) product development requirements and best practices associated with biologics, biosimilars, gene therapy and cell therapy products.
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:
Pricing Amounts & Deadlines
16 November 2020–11 January 2021: $800 Member| $900 nonmember
12 January 2021-8 February 2021: $900 member | $1000 nonmember
At the conclusion of this workshop, participants should:
Who Should Attend?
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 biologic 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)
NOTE: The agenda may vary based on changing requirements.
Patricia Cash, PhD, Independent Regulatory Consultant
Patricia W. Cash is a senior leader with more than 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 PhD and a master’s in chemistry from Rutgers University, and an MBA in 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 and vaccines industry, including assignments in quality control, research, product development and scale-up, bioanalytical development and validation, project management, and regulatory affairs. He was employed by Sanofi Pasteur for 28 years, most recently in the position of senior director, head of North American regulatory affairs. He teaches graduate level courses in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance program. He holds master’s degrees in quality assurance and regulatory affairs, and Chemistry, and has earned Regulatory Affairs Certification (RAC).
Erica Shane, PhD, Independent Consultant
Erica Shane is senior biotechnology professional with more than 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. She received her doctorate from Carnegie Mellon University in chemical engineering.
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 firstname.lastname@example.org.
If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at email@example.com.