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  • 1.  Regulatory Focus Article Series: Global Regulatory Strategies and Best Practices Now Released

    Posted 13-May-2019 09:33

    Hi Regex Members,

    The 2nd Quarter Regulatory Focus Article Series of 2019 is here. In this RF series, you will find a collection of insightful articles covering global regulatory strategies and best practices. It is a pleasure to bring together some of the top regulatory experts from around the world-all with diverse backgrounds-to offer their expertise to help clarify and discuss some of today's hottest regulatory topics.

    Individual articles examine:

    • Is Your Software a Medical Device?
    • Postmarket Surveillance in a Digital Health Solution
    • Cybersecurity Susceptibilities in Networked Medical Devices
    • Risk Management: A Difficult to Implement Regulatory Requirement
    • Managing Regulatory Intelligence for Medical Devices
    • Proactive Regulatory Intelligence Communication
    • The African Pharmaceutical and Medical Industry: Growth Factors
    • Chinese Health Policy and Regulatory Authorities Overview
    • Regulatory Pathways for Orphan/Rare Pediatric Diseases: Global Overview
    • Planning and Submission Considerations for Animal Drugs
    • Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry

    Download the latest RF Article Series here.

    Mark your Calendars: To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 12 June, from 1:30-2:30 PM EDT right here on RegEx. Stay tuned for the announcement of the expert panel.

    I look forward to hearing your thoughts on this article series.

    Best wishes,

    Gloria



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    Gloria Hall
    Rockville MD
    United States
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  • 2.  RE: Regulatory Focus Article Series: Global Regulatory Strategies and Best Practices Now Released

    Posted 16-May-2019 16:36

     

     

    Ugh, I'm having quite some difficulty accessing this.

     

    It seems to keep circling back to this page (https://www.raps.org/news-and-articles/rf-article-series) that tells me to log in (even though I'm logged in). 

     

     

     




    Original Message


  • 3.  RE: Regulatory Focus Article Series: Global Regulatory Strategies and Best Practices Now Released

    Posted 17-May-2019 12:06
    I had the same experience. So, I clicked on the "login to gain access" button even though I was logged in and I was taken to the page with all the articles.

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    Mary Strickland
    Salt Lake City UT
    United States
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    Original Message


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