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Q4 Regulatory Focus (RF) Article Series 2020 Regulatory Focus Article Series Q4

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.

Regulatory Intelligence

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:

  • The Shifting Global Regulatory Landscape
  • Global Regulatory Strategies and Best Practices
  • The Strategic Role of the Regulatory Professional
  • Risk Management and Quality
  • Global Strategies for Drugs and Devices
  • Executive Leadership and Management
  • Global Regulatory Policy and Strategy
 

Upcoming for 2021

  • Global Clinical Trials
  • Artificial Intelligence in Regulatory Affairs
  • Quality and Compliance
  • 2021 Convergence

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.

Access RF Article Series


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