Join the first webinar of our series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 16 January 2025. In this webinar, we will be covering the general aspects; giving you a brief introduction into regulatory affairs and the documentation required during drug development and registration.
In the remaining webinars in the series, we will delve deeper into the various documents required for early development and highlight the importance of involving skilled regulatory and medical writers. These sessions, scheduled for 2025, will cover:
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: Marieke van den Dobbelsteen
With a PhD in Immunology from Leiden University, Marieke joined Venn in 2008 as a Group Leader of Clinical Trial Management & Medical Writing in combination with the role as a Drug Development Senior Consultant.
Marieke has:
Key learnings:
WHY: A carefully thought out strategy combined with comprehensive writing are key to ensure efficient and effective regulatory interactions.
HOW: In accordance with applicable regulations. Differences between EMA / FDA and small and large molecules.
WHO: Skilled regulatory and medical writers and consultants. Venn can be your partner is this journey.
WHAT: Briefing book, CTD modules, IND/CTA etc. Opportunities for interaction with regulators.
WHEN: Start interaction with regulators early and have them often.
