February 27 at 3:00 pm - 4:00 pm GMT

Webinar - WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing (Non-Clinical and Clinical)

Join our third and final webinar of the series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 27 February 2025. This webinar will delve deeper into the various documents required for early development and highlight the importance of involving skilled regulatory and medical writers from a non-clinical and clinical development perspective.

Regulatory documents should be prepared for each new drug under development. Based on these documents, regulators will decide if clinical studies may be initiated and whether a drug will be approved for marketing. For each phase during drug development, different documents must be written.

We would love to address any specific questions you may have. Please share your questions with us by sending an email to getintouch@vennlife.com

Speaker: Arthur Noach

With a PhD on the border between toxicology and pharmaco-kinetics from Leiden University and registered as a pharmacist, Arthur joined Venn 25 years ago as a pharmacokinetics (PK) consultant and is a non-clinical senior consultant since 2000.

​Arthur is a/an:

  • expert in small molecules, biologics and vaccines​;
  • Specialist in design of non-clinical development strategy/studies;
  • Author of non-clinical regulatory documentation (IB, IND modules, briefing materials)​;
  • SD/PI for (non-)GLP non-clinical PK studies​;
  • Final responsible for all non-clinical PK studies at Venn​.

Key learnings:

Non-clinical and clinical aspects of regulatory writing, covering:

  • IND/CTA submissions
  • Non-clinical and clinical modules of CTD
  • Investigators Brochure (IB)
  • Briefing Books
  • Best practices & what to avoid

Note: The first and second webinar of this series is not a prerequisite to this final webinar. You can attend this webinar without having participated in the first and second sessions.

Details

Date:
February 27
Time:
3:00 pm - 4:00 pm GMT
Event Category:
Register Here
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