WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing (CMC)
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 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.
📅 Date: Thursday 6th February 2025
🕒 Time: 4-5pm CET
🎙️ Speaker: Heimen Kooy
👥 Hosted by: Venn Life Sciences
🔑 Key Learnings:
CMC Regulatory aspects/regulatory writing considerations for:
• IND/IMPD submissions;
• Agency meetings and briefing books
• CMC for MAA/BLA submissions;
• NCE/ NBE differences in CMC writing;
• FDA/EU differences.
About 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:
• 25+ years of experience in the pharma industry, of which 15+ years is in CMC Regulatory Affairs;
• Experience with biological products, including recombinant proteins, vaccines, and antibody-drug conjugates (ADCs);
• Expertise n regulatory, quality, and product development;
• Skills in RA-CMC strategies, regulatory submissions, and liaising with US and EU agencies.
🎟️ Registration: FREE of charge
🔔 Stay Tuned: Follow this event for updates and announcements about upcoming free webinars.
You can view this webinar from your computer, tablet or mobile phone.
📅 Date: Thursday 6th February 2025
🕒 Time: 4-5pm CET
🎙️ Speaker: Heimen Kooy
👥 Hosted by: Venn Life Sciences
🔑 Key Learnings:
CMC Regulatory aspects/regulatory writing considerations for:
• IND/IMPD submissions;
• Agency meetings and briefing books
• CMC for MAA/BLA submissions;
• NCE/ NBE differences in CMC writing;
• FDA/EU differences.
About 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:
• 25+ years of experience in the pharma industry, of which 15+ years is in CMC Regulatory Affairs;
• Experience with biological products, including recombinant proteins, vaccines, and antibody-drug conjugates (ADCs);
• Expertise n regulatory, quality, and product development;
• Skills in RA-CMC strategies, regulatory submissions, and liaising with US and EU agencies.
🎟️ Registration: FREE of charge
🔔 Stay Tuned: Follow this event for updates and announcements about upcoming free webinars.
You can view this webinar from your computer, tablet or mobile phone.
