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  • Hello RAP Community! My name is Angelina Huynh, and I'm an early career professional specializing in sales and marketing within the biologics CDMO and CRO industry. Currently, I'm studying for the RAC-Drugs certification to deepen my understanding of ...

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    Legal manufacturer applicability

    This message was posted by a user wishing to remain anonymous A manufacturer of medical devices is contemplating to sell the intellectual property and commercialization rights of a medical device to another company. However, the original developer will ...

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    Product Transfer during acquisition

    This message was posted by a user wishing to remain anonymous A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing ...

  • T here’s limited regulatory guidance on gene therapies for many drug manufacturer s and how i t can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop , @Janmeet Anant will ...

  • The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological ...

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30-Jan-2023 Large Project (Long Term) 40  points
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30-Jan-2023 Large Project (Long Term) 40  points
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23-Feb-2023 Quick Task (less than 1 hour) 2  points
28-Feb-2023 Small Project (multiple days) 20  points
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12-Apr-2023 Small Project (multiple days) 20  points
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