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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.
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Your Latest RAPS Member Benefit is here
RAPS is pleased to bring you another edition of its Regulatory Focus Article Series, comprised of timely and relevant technical articles, case studies, interviews, and research reports. These topic-focused collections are intended to benefit RAPS members responsible for healthcare-related products. Articles are developed by global subject-matter experts representing a range of regulatory responsibilities and organizations. These quarterly electronic publications are developed for the benefit of RAPS’ members.
RI is a cornerstone of the regulatory landscape, and evidence-based information and the tools for monitoring and gathering it, are its prized components. RI professionals are regulatory sleuths, key players in pulling together that evidence to shape the policies, legislation, regulations, and guidelines regulators use in strategizing for drug development, approval, and product maintenance. In this series, a number of global regulatory affairs specialists write on aspects of regulatory intelligence that would help product developers stay current with the latest requirements and achieve their development goals in a timely, cost-effective manner.
Inside the Series:
Advanced therapies: Navigation and application of EU and US guidelines during product development
By Kirsten Messmer, PhD, RAC, and Richard Dennett, PhD
FDA warning letters in 2020 reveal concerns around purity and data integrity
By Sarah Tanksley, MS, and Audrey Francis
Regulation of cell and gene therapy products in China
By Yingying Liu, MSc
Current China NMPA clinical pathways for medical device registration
By Grace Fu Palma, MBA, Jason Zhang, MD, Xiaolian Zou, and Beibei Xing, PhD
Regulatory tools for generic drug companies: Formal FDA meetings and controlled correspondence
By Sonal Jagani, MS, RAC
EU regulatory tools for RA professionals
By Maria E. Donawa, MD
US-focused regulatory toolbox: The basics
By Thomas Padula
Starting out: A beginner’s toolkit of US regulatory resources
By Holly Korzendorfer, PhD
Adopting regulatory intelligence strategies to foster the evolving landscape
By Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, George A. Cusatis MS, RAC, Jessica L. Hale, PharmD, Jessica Schlegel, MS, and Suraj Ramachandran, MS, RAC
Access more benefits in previous Series on the following topics:
Upcoming for 2021
To access your member benefit, simply login and select the e-Book ‒ RF Article Series: The Shifting Global Regulatory Landscape ‒ in the Member Knowledge Center.
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