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Q3 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 range of regulatory responsibilities and organizations. These quarterly electronic publications are developed for the benefit of RAPS’ Members.

Regulatory Strategy for Drugs and Devices

Regulatory affairs is a fluid and challenging field, even when we’re not weathering a global pandemic. No matter the area of specialty – regulatory pathways and processes, manufacturing, clinical trials, or regulatory oversight and guidance – there is constant pressure to balance staying current and timely delivery with longer-term, creative strategizing. In this series, we bring together the voices of top global regulatory experts who their share insights and advice on addressing challenges through early and deliberate strategizing.

Inside the Series:

A military-civilian perspective on real-world evidence to support regulatory decision making
By Todd E. Rasmussen, MD, and Brian J. Young, MBA
Outsourcing in regulatory operations
By Jen Multari, MSc, RAC
Interacting with competent authorities during COVID-19 – A European perspective
By Anna Baran, MD, and Stephanie Geiger, PhD
The Canadian application process and alternate pathway for COVID-19‒related clinical trials
By Mukesh Kumar and Melanie Oakley
Managing uncertainty: Regulatory reporting in multinational trials during COVID-19
By Ioana Ionita, MA
Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers
By Ginny Hu, PhD, and Neeta Sharma, MS
Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers
By Neeta Sharma, MS, and Ginny Hu, PhD
Latin America market opportunities for food supplements: Navigating regulatory complexities
By David Pineda Ereño, LLM
Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy
By Manfred Ruthsatz, PhD, Emmanuelle Voisin, PhD, Nelson Lima, PhD, and Kathleen D’Hondt, PhD
Recasting CAPA as a continuous improvement process
By Kathryn Merrill
Designing a biologics manufacturing facility: Early planning for success
By Mo Heidaran, PhD, R. Heath Coats, MS, and Steve Winitsky, MD

Access more benefits in previous Series on the following topics:

  • The Shifting Global Regulatory Landscape
  • 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 

  • Regulatory Intelligence and Policy
  • Facing the new world challenges
  • Global transformation of regulatory landscape
  • Global regulations
  • Global regulatory affairs

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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