Interview: Regulatory 4.0

Michael M. Kania
April 14, 2021
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Medical Device Regulation

We spoke with Dr. Bassil Akra from Akra Team to learn more about the future of Regulatory Affairs, Quality Management and R&D. Digitalization is a must-have to meet the increasing requirements and at the same time stay competitive. Truly interesting to see this issue through the lens of a consultant who was previously working for a Notified Body.

Audio: German
Subtitles: English

‍Topics

  • Insights from a former Notified Body employee
  • Current problems
  • Manufacturers & Notified Bodies: "they also put on their trousers one leg at a time"
  • Structured Digitalization of RA/QA compared to IDMP/EMA Pharma world
  • Digital Future

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