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RegRapPod − September 2023


Vol.20 #8: In the September 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Vickie Goff about globalisation and the supply chain.

  • September 2023 – Contents

  • The worldwide web of regulation

  • Q&A:
    Navigating the
    pharmaceutical supply chain

  • Navigating the global supply of starting materials for cell-based therapies

  • Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry

  • Biosimilars CMC development considerations from the sponsor perspective

  • Warning letters for direct-to-consumer advertising: a five-year retrospective analysis

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  • July/August 2023 – Contents

  • Equal access to medicines:
    finding the balance

  • African Medicines Agency and a new African regulatory ecosystem

  • EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products

  • A year of clinical trials under IVDR:
    a sponsor’s perspective

  • The impact of clinical data requirement
    changes following EU Medical Device Regulation (2017/745) and Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)

  • Regulatory challenges and opportunities facing hearing aid manufacturers in Europe

  • A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – is there a difference and does it matter? Part 2

  • RegRapPod − July/August 2023

  • European Parliament gives first stage approval for revised EMA fees

  • Change Across the Medical Device Landscape

  • Northern Ireland deal permits GB medicines but not medical devices

  • UK set to accept CE mark for medical devices until 2028

  • US Food and Drug Law Institute Annual Conference