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. 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.
📅 Date: Thursday 27th February 2025
🕒 Time: 4-5pm CET
🎙️ Speaker: Arthur Noach
👥 Hosted by: Venn Life Sciences
🔑 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.
About 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.
🎟️ 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 27th February 2025
🕒 Time: 4-5pm CET
🎙️ Speaker: Arthur Noach
👥 Hosted by: Venn Life Sciences
🔑 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.
About 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.
🎟️ 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.
