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Regulatory Focus (RF) Article Series 2019-Regulatory-Focus-Article-Series-Q4

The Regulatory Affairs Professionals Society (RAPS) is pleased to announce a quarterly series of electronic publications for RAPS’ Members only. The RF Article Series are comprised of timely and relevant Regulatory Focus 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 wide range of regulatory responsibilities and organizations.

Regulatory Intelligence and Policy:
Shaping the Global Landscape

Welcome to the fourth edition of the 2019 Regulatory Focus Article Series. Inside you will find a collection of insightful articles covering global best practices in regulatory intelligence (RI) and policy. It is a pleasure to bring together some of the top RI thought leaders from around the world—all with diverse experiences—to offer their perspectives on the importance of RI and the integral role RI professionals play in defining strategy for companies in regard to development, approval and maintenance of products, as well as any changes to regulations impacting the global regulatory landscape. 

Individual articles examine:
  • Proactive Regulatory Intelligence Communication
  • FDA Meetings: The Application of RI in Preparation and Execution
  • Managing Regulatory Intelligence for Medical Devices
  • The Role of AI on the Supply Chain Securement In Healthcare
  • The Overview of Chinese Health Policy and Regulatory Authorities
  • Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine
  • Protecting the Healthcare Infrastructure: Global Cybersecurity Compliance
  • Regulatory Strategist Toolbox: 2018 FDA Changes Regulatory Intelligence Briefing
  • The Value of Engagement With Trade Associations in Policymaking, Regulation and Standardization
  • The Botanical Safety Consortium (BSC): The Development of a 21st Century Framework
Topics covered previously include​: Topics to be covered in 2019 and 2020 include:
  • Regulatory Policy and Strategy
  • Strategic Role of the Regulatory Professional
  • Shifting Global Regulatory Landscape
  • Regulatory Intelligence

To Access Your Member Benefit, simply login and select the e-Book: RF Article Series:Regulatory Intelligence and Policy: Shaping the Global Landscape in the Member Knowledge Center.

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