Introducing a New RAPS Member Benefit

Regulatory Focus (RF) Article

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.

Global Advertising, Promotion and Labeling Regulations: What You Need to Know

Welcome to the fourth edition of the 2018 Regulatory Focus Article Series. Inside you will find a collection of insightful articles covering global Advertising, Promotion and Labeling (APL) regulations. It is a pleasure to bring together some of the top regulatory thought leaders from around the world—all with diverse backgrounds—to offer their expertise to help clarify and perhaps solve today’s most pressing APL challenges.

Individual articles examine:
  • The Changing Regulatory Landscape of Advertising and Promotion
  • Optimize Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise
  • Pregnancy and Lactation Labeling Rule: Strategies for Updating Prescription Drug Labels for Compliance
  • Clarifying FDA’s Off-Label Promotion Efforts
  • Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Products 
  • Medical Device Marketing Under Substantial Equivalence—FDA Clearance and USPTO Patent Considerations
  • Regulatory Challenges in Mobile Medical Applications
  • Australian Regulatory Framework of Over-the-Counter and Complementary Medicine
  • Canadian Drug Advertising Regulations
Other topics covered in 2018 include: Topics to be covered in 2019 include:
  • Risk Management and Quality
  • 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: Global Advertising, Promotion and Labeling Regulations: What You Need to Know in the Member Knowledge Center.

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