Regulatory Open Forum

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  • 1.  glossary and definitions

    Posted 15-Nov-2017 07:58
    ​​Hello, I am looking for a good resource (listing, website, reference....)on Regulatory glossary or definitions of regulatory affairs terms (ex. Convergence, harmonization, life cycle management, post approval change, reliance) etc.
    Thank you and kindest regards

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    Norbert De Clercq
    Wavre
    Belgium
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  • 2.  RE: glossary and definitions

    Posted 15-Nov-2017 11:29
    ​Hi Norbert,

    I am not personally familiar with a "regulatory dictionary", but here are a couple of places to start:
    21CFR820.3 Definitions (Medical Devices)
    Drugs@FDA Glossary of Terms
    REGULATION (EU) 2017/745 - Article 2 Definitions

    Also - the terms and definitions section of standards such as ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes, ISO 9000 Quality management systems -- Fundamentals and vocabulary and ISO 14971 Medical devices -- Application of risk management to medical devices may be of value to you.

    Hope this helps,
    Liz


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    Elizabeth Goldstein RAC
    Regulatory Affairs Project Manager
    California
    United States
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    Original Message


  • 3.  RE: glossary and definitions

    Posted 16-Nov-2017 10:12
    RAPS has an entire series of books on the fundamentals of regulatory affairs and they also have a series of guides on regulatory acronyms and definitions:

    Fundamentals of Regulatory Affairs Series | RAPS

    RAPS | Regulatory Affairs Professionals Society



    ------------------------------
    Cari Newton RAC
    3D Communications
    Raleigh NC
    United States
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    Original Message


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