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Q1 Regulatory Focus (RF) Article Series 2020-Regulatory-Focus-Article-Series-Q1

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 Strategic Role of the Regulatory Professional

In this edition, Regulatory Focus has brought together some  of the top regulatory influencers from around the world—all with diverse  experience—to offer their perspectives on how the shifting landscape and evolving  regulatory approaches are impacting the regulatory profession today. With the  need of regulatory science to keep pace with the changing global landscape,  technological advancements, increased innovation and the complexity of the drug  and device development process, the role of the regulatory professional has  become ever more strategic. This insightful collection of articles illustrates  the expanding strategic role of regulatory professionals and demonstrates the  vital role regulatory plays within organizations and throughout the  product lifecycle.

Inside the Series:

The Changing Role of the Regulatory Professional
By Adriana Becker

How the Role of Regulatory Operations Professionals Will Evolve in the new Decade
By Rachel Belani

Why Understanding Regulatory Affairs is Important to Key Company Decision Makers
By Isabella Schmitt

Writing Informed Consents Documents: A Balancing Act
By Viji Ramesh

Regulatory Affairs Consultants. Who needs them and why?
By Steven J. Knapp, MS, PharmD and Andrew S. Verderame, MBA, RAC

Consultants: How to Hire and Engage for Success
By David W. Husman, PhD, ASQ CPGP, RAC

Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement
By Kate Morris Jurcik

Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization
By Kate Forte, MSc

Professional Development: Benefits of Obtaining Professional Qualifications
By Orin Chisholm, GCULT, PhD, SFHEA

Regulatory Leadership for a Culture of Quality
By Amaris Ajamil, PhD, RAC

Critical Thinking and Leadership Skills for Regulatory Professionals
By Robert E. Yocher, MHSC, FRAPS

Access More Benefits With These Series

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
 

Here are the Series you Have to Look Forward to in 2020:

  • Shifting Global Regulatory Landscape
  • 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 Strategic Role of the Regulatory Professional in the Member Knowledge Center.

Access RF Article Series


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