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Who We Are
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    Contact Us
    Advancing the Profession
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    Work for RAPS
    RAPS in Europe
    Press Room
    Advertise
    Year In Review
  • About the Regulatory Profession

    The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

    Learn More About Regulatory
News & Articles
    Regulatory Focus™
    About Regulatory Focus
    Subscribe to RF Today
    Podcasts
    Editorial Advisory Committee
    Copyright & Terms of Use
    Feature Articles
    Regulatory Recon
    Regulatory Explainers
    Regulatory Trackers
    RAPS' Latest
    RF Quarterly
  • Submit an Article

    Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.

    LEARN MORE
Membership
    Join RAPS
    Renew Your Membership
    Member Dashboard
    Member Directory
    Regulatory Exchange Community
    Chapters & Local Networks
    Get Involved
    Enterprise Membership
    RegEx Community App
    Volunteer Opportunities
    RAPS Fellows
    Awards
  • Regulatory Code of Ethics

    One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

    Follow the Code
  • Member Knowledge Center

    Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.

    Get Started
Careers
    Careers
    Find a Job
    Post a Job
    About the Regulatory Profession
    Onboarding Essentials
    RAC Credential
    Scope of Practice Survey
    Career Fairs
    RegEx Career Community
    Regulatory Competency Framework
  • Regulatory Competency Framework

    Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

    LEARN MORE
Education & Events
    Education & Events
    E-Learning
    In-Person
    European Events
    Calendar
    RAPS Convergence
    Learning Portal
    Executive Development
    RAC Prep
    Online Workshops
    Custom Corporate Training
    RAPS Euro Convergence
  • RAPS Euro Convergence 2021

    RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.

    LEARN MORE
  • RAPS Convergence 2021

    Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.

    LEARN MORE
Publications & Resources
    Publications & Resources
    Books
    Fundamentals Series
    Regipedia
    Podcasts
    University Resources
    Suppliers Guide
    University Degrees & Certificates
    Publication Groups Rates
    Call for Authors
  • Just Released: Regulatory Intelligence 101, Third Edition

    With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.

    ORDER YOURS
  • Regipedia

    Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.

    Get involved
RAC Credential
    RAC Credential
    RAC Spotlights
    Apply
    Prepare for the Exam
    Exam Sites & Scheduling
    RAC Benefits
    RAC or Certificate Training
    RAC Resources
    Maintain your RAC
    Current RAC Holders
  • NEW! RAC Spotlights

    Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.

    LEARN MORE

Regulatory Focus

Regulatory Focus™ > News Articles

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    Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    • 28 May 2020
    • By Ralf D. Hess, MSc, PhD, Henric Wassmer, Siegfried Schmitt, PhD, Martin Hug, PhD, Anmar Marouf, PhD, Dominik M. Aumer, MBA, Moritz Haucke, MBA, Simon Schulz, MSc, PhD 
    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
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    Feature ArticlesFeature Articles

    Implementation of IVDR and MDR Into National Legislation

    • 05 September 2019
    • By Ralf D. Hess, MSc, PhD, Dominik M. Aumer, MBA, Simon D. Schulz, MSc, PhD 
    This article discusses current revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in the European Union (EU). The authors use an example from Germany’s experience and efforts to examine revisions from an implementation perspective. The impact of this new regulatory environment and associated challenges for medical device and in vitro diagnostic device manufacturers are discussed as well as hurdles and “bottlenecks” that could m...
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    Feature ArticlesFeature Articles

    Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

    • 22 July 2015
    • By Ralf D. Hess, MSc, PhD, Mark Mathieu, Dieter Russmann, MD, 
    This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...
    • 1

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