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Q2 Regulatory Focus (RF) Article Series 2020 Regulatory Focus Article Series Q2

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 wide range of regulatory responsibilities and organizations. These quarterly electronic  publications are developed for the benefit of RAPS’ Members.

The Shifting Global Regulatory Landscape

Since the Q1 RF Series, the COVID-19 pandemic has significantly changed our world and not least, the global regulatory landscape. This collection of in-depth articles takes on an additional relevance in the prevailing disruption and uncertainly. It is a pleasure to bring together the voices of top regulatory experts from around the world as they share their insights and offer guidance on ensuring continuity in manufacturing and regulatory processes in an evolving regulatory landscape.

Inside the Series:

EU IVDR Changes Regulatory Landscape
By Jordanna Jayne, MS, PhD
Preparing for Virtual Regulatory Meetings
By Jim DiBiasi, Cindy DiBiasi
Optimizing Remote Internal Quality Audits
By Tammy M. Pelnik, MS
Electronic Platforms for Submission of Clinical Trial Information
By Federico Bonacci, MD, Siegfried Schmitt, PhD, Moshe L. Reiss, MBA, MSN, RN, Viviana Mascilongo, PhD, Manuel Neukum, MBA, Daniel Sürder, MD
Global Orphan Drug Regulation
By Julie Watchorn, RAC
Adopting Regulatory Intelligence and Strategy to Foster the Evolving Landscape
By Jessica Schlegel, MS, Jessica L. Hale, PharmD, Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, George A. Cusatis, MS, RAC, William Mejias, Dan Visco, Suraj Ramachandran, MS, RAC
Economic Operators: Roles and Obligations Under EU’s MDR
By Randolph Fillmore
The Evolution of the China Regulatory Environment: Review and Update
By Alistair Davidson, Guoliang Liu, Bill Wang
The Changing Regulatory Landscape for Insulin: FDA and Congress Seek to Increase Pressure on Pricing
By Charity Duran, PhD, RAC, Kathleen Candando, PhD, RAC
Applying FDA’s Rules in the New World of Online Marketing and Crowd Funding
By Suzanne Levy Friedman

Access more benefits in previous Series on the following topics:

  • Regulatory Intelligence and Policy
  • Global Regulatory Strategies and Best Practices
  • Risk Management
  • Global Advertising, Promotion and Labeling Regulations: What You Need to Know
  • Orphan Drug Regulations: A Global Perspective
  • Transitioning to the New EU MDR and EU IVDR
  • Global Reimbursement Strategy
  • Regulatory Management and Leadership Strategies

Upcoming Series for 2020:

  • Regulatory Strategy for Drugs and Devices
  • Regulatory Intelligence and Policy

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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