Join our second webinar of the series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 6 February 2025. Following our first webinar on general aspects on Thursday 16 January 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 CMC perspective. Our third and final webinar of the series on 27 February will focus on Non-Clinical & Clinical.
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: Heimen Kooy
With a MSc in Chemistry from Radboud University, Heimen joined Venn in 2016 as a Regulatory Affairs (RA)-CMC senior consultant.
Heimen has:
Key learnings:
CMC Regulatory aspects/regulatory writing considerations for:
