Interview: Regulatory 4.0

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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