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Nihan Burul Bozkurt

Health Policies Director Association of Research Based Pharmaceutical Companies

Nihan Burul Bozkurt received her B.Sc. degree from Hacettepe University Faculty of Pharmacy. She holds M.Sc. and Ph.D. degrees in Pharmacology from the same University. Ms. Burul Bozkurt carried out postdoctoral studies in Karolinska Institutet, Alzheimers Disease Research Center, Sweden. Afterwards, she worked as Clinical Director at a private R&D Center. Between May 2016 and September 2021 she hold the position of Head of the Clinical Trials Department at the Turkish Medicines and Medical Devices Agency (TITCK, Türkiye). Ms Burul Bozkurt has been working as the Health Policies Director at Association of Research Based Pharmaceutical Companies (AIFD) since September 2021.

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See Nihan Burul Bozkurt at this event

  • Day 4 Friday 6 December

Advancing clinical trials: The impact of E6(R3) guideline

09:15 - 10:30 CET / 19:15 - 20:30 AEDT

Session objectives:

  • Comprehend E6(R3) Guideline Revisions: key updates in E6(R3) and their significance for enhancing clinical trial practices and aligning with international standards.
  • Analyze Regulatory Preparations: how different regulatory authorities are preparing for the implementation of E6(R3).
  • Explore Data Integration: Consider the impact of E6(R3) on the use of Real-World Data (RWD) and Real-World Evidence (RWE), including the associated challenges and opportunities.

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