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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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
Objectives
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.
Agenda
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.
Speakers
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.
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.