Lock Members Only close arrow-right cart search google-plus facebook twitter youtube flickr linkedin calendar user menu menu-close print share circle-down help briefcase latest recon star word-bubble news
RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.
Skip to Main Navigation Skip to Main Content Skip to Footer
8553b334-65f3-4a6c-bf5b-1d8fd1551c9a
Close Login

Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.

E-mail address & Password Combo is invalid
  • Forgot Password?
  • Create an Account
Close Search
Regulatory Affairs Professionals Society (RAPS)
  • Menu
  • TOPIC
  • BIOTECHBREXITCAREERSCOMBINATION PRODUCTSEU MDRIVDSMANAGEMENTMEDICAL DEVICESPHARMACEUTICALSREGULATORY INTELLIGENCE
  • Open/Close Search
  • Community
  • Calendar
  • Market Place
  • My Account Open/Close Sign In
  • Join

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.

  • Who We Are
    • Who We Are
    • Contact Us
    • Advancing the Profession
    • Board of Directors & Governance
    • 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 Article Series
    • 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
      • 2021 Events Calendar

        Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.

        DOWNLOAD NOW
      • Euro Convergence 2021

        Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.

        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 Writing: An Overview

        An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation

        BUY NOW
    • RAC Credential
      • RAC Credential
      • Apply
      • Prepare for the Exam
      • Exam Sites & Scheduling
      • Maintain your RAC
      • RAC Benefits
      • RAC or Certificate Training
      • RAC Resources
      • Current RAC Holders
      • Do You Have the RAC Prep Tools You Need?

        From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.

        BROWSE PREP TOOLS
    Regulatory Focus
    • News
      • Pharma/Biotech
      • Devices/ IVDs
      • Combo Products
      • RAPS Announcements
    • Member Exclusive
      • Features
      • Latest
      • Editorial Calendar
      • Article Series
      • Join Now
    • Tools & Resources
      • Explainers
      • Podcasts
      • Legislative Trackers
    • About
      • About Regulatory Focus
      • Submissions & Guidelines
      • Editorial Advisory Committee
      • Copyright & Terms of Use
      • Press Room
      • Advertise
      • Contact
    Subscribe
    • Who We Are
    • News & Articles
    • Membership
    • Careers
    • Education & Events
    • Publications & Resources
    • RAC Credential
    Who We Are
      Who We Are
      Contact Us
      Advancing the Profession
      Board of Directors & Governance
      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 Article Series
      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
      • 2021 Events Calendar

        Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.

        DOWNLOAD NOW
      • Euro Convergence 2021

        Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.

        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 Writing: An Overview

        An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation

        BUY NOW
      RAC Credential
        RAC Credential
        Apply
        Prepare for the Exam
        Exam Sites & Scheduling
        Maintain your RAC
        RAC Benefits
        RAC or Certificate Training
        RAC Resources
        Current RAC Holders
      • Do You Have the RAC Prep Tools You Need?

        From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.

        BROWSE PREP TOOLS

      Regulatory Focus

      Regulatory Focus™ > News Articles

      Narrow Results

      You've Selected

      • Author
      Clear All
      Today
      Today
        • 1
      • Story Thumbnail

        Test

        • 08 April 2018
        • By A. Kramm 
      • Story Thumbnail
        RAPS' LatestRAPS' Latest

        Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

        • 18 December 2015
        • By James A. Smith, B. Naughton, A. Kramm, Graham Smith, A. Ohanjanyan, Mark De Simone, Rob Horne, David A. Brindley 
        The following chapter is an excerpt taken from  Fundamentals of EU Regulatory Affairs, Seventh Edition . Objectives Introduce the problem of falsified medicines Define falsified and counterfeit medicines Define active substances and excipients Explain the aims and scope of the Falsified Medicines Directive ( FMD ) Directive 2011/62/EU ) Identify requirements for different stakeholders in the medicines supply chain arising from the FMD ...
        • 1

      Regulatory Affairs Professionals Society (RAPS)
      5635 Fishers Lane, Suite 400
      Rockville, Maryland 20852

      P +1 301 770 2920 F +1 301 841 7956
      Email: raps@raps.org
      • MEMBERSHIP
      • PRESS ROOM
      • STORE
      • FAq/HELP
      • FEEDBACK
      • Contact
      • Advertise
      • Suppliers Guide
      • Privacy Policy
      • TERMS AND CONDITIONS
      • Twitter
      • Facebook
      • LinkedIn
      • Google Plus
      • YouTube

      © 2021 Regulatory Affairs Professionals Society.