Introducing a New RAPS Member Benefit

Regulatory Focus (RF) Article
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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.

Risk Management Principles: A Global Perspective

Welcome to the first edition of the 2019 Regulatory Focus Article Series. Inside you will find a collection of insightful articles covering the latest risk management principles. It is a pleasure to bring together some of the world’s leading regulatory professionals—all with diverse backgrounds—to offer a comprehensive update on the emerging and evolving field of therapeutic risk management.

Individual articles examine:
  • Emerging Trends in Risk Management for Pediatric Patients
  • Postmarket Surveillance in a Digital Health Solution World: Challenges and Opportunities for an Evolving Industry
  • The Enforcement of Risk Evaluation and Mitigation Strategy (REMS)
  • Medicinal Products Benefit-Risk Management: The Role of Patient Input
  • Implications for Pharmaceutical Risk Management in the 21st Century Cures Era
  • Medical Device Risk Management
  • How FDA is Using REMS to Help Manage the Opioid Crisis
  • Risk Management: What Regulatory Professionals Need to Know
Other topics covered in 2018 include: Topics to be covered in 2019 include:
  • Global Strategies for Drugs and Devices
  • Regulatory Management and Leadership
  • Regulatory Intelligence, Strategy and Policy

To Access Your Member Benefit, simply login and select the e-Book: RF Article Series: Risk Management Principles: A Global Perspective in the Member Knowledge Center.

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