WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing (General Aspects)
Join the first webinar of out series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing. This webinar will explore the general aspects, giving a brief introduction into regulatory affairs and the documentation required during drug development and registration.
📅 Date: Thursday 16th January 2025
🕒 Time: 4-5pm CET
🎙️ Speaker: Marieke van den Dobbelsteen
👥 Hosted by: Venn Life Sciences
🔑 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.
About 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:
• 25+ years of clinical development experience;
• Experience in writing protocols, consent forms, clinical trial reports, DSURs, CTD modules, and publications;
• Thorough understanding of clinical trial regulations and ICH-GCP guidelines.
🎟️ 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 16th January 2025
🕒 Time: 4-5pm CET
🎙️ Speaker: Marieke van den Dobbelsteen
👥 Hosted by: Venn Life Sciences
🔑 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.
About 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:
• 25+ years of clinical development experience;
• Experience in writing protocols, consent forms, clinical trial reports, DSURs, CTD modules, and publications;
• Thorough understanding of clinical trial regulations and ICH-GCP guidelines.
🎟️ 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.
