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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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This brand new book offers practical guidance on navigating this exciting area of converging technologies.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
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 controls (CMC) product development requirements and best practices associated with biologics, and 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: • Biological product development from early phase to commercialization • Source material • Cell & seed banks • Upstream and downstream processing, formulation and final product production • Characterization and testing • Demonstrating comparability • CMC regulations and guidance applicable to biologics • Quality by Design • Adventitious agents risk management
Day 1 – Tuesday, 13 July 2021
9:00 am – 9:15 am Introductions, announcements, and overview of class
9:15 am – 9:45 am Overview of types of biologic products
9:45 am – 10:45 am Regulation of biological products in US
10:45 am – 11:00 am Q and A and Break
11:00 am – 12:00 pm Approach to product design and development and CMC teams
12:00 am – 1:00 pm Lunch
1:00 pm – 2:00 pm Early stage Manufacturing Process
2:00 pm – 2:30 pm CMC physicochemical testing on biological products
2:30 pm – 2:45 pm Q and A and Break
2:45 pm – 3:15 pm Quality attribute risk assessment
3:15 pm – 3:45 pm Risk assessment from Process perspective
3:45 pm – 4:00 pm Q and A, End of day 1!
Day 2 – Wednesday, 14 July 2021
9:00 am – 9:30 am Biofunctionality/ Potency assessment
9:30 am – 10:00 am Comparability studies in developmental stages
10:00 am – 10:30 am Pre-IND meeting planning and strategy
10:30 am – 10:45 am Q and A and Break
10:45 am – 11:45 am Manufacturing Process Considerations
11:45 am – 12:00 pm Q and A
1:00 pm – 1:30 pm Specifications and analytical methods
1:30 pm – 2:00 pm Stability and Forced degradation studies
2:00 pm – 2:15 pm Q and A and Break
2:15 pm – 3:00 pm Adventitious agents risk mitigation
3:00 pm – 3:30 pm Sterility assurance/aseptic processing
3:30 pm – 4:00 pm Q and A and discussion, end of class!
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.
Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.