Regulatory Writing SIG Meet & Share on Nonclinical CTD Modules

Thursday 11th September 13:00-14:00 CET

At this Meet & Share, Dr Arthur Noach will give an overview of the various types of studies that make up the nonclinical package described in the modules of the Common Technical Document (CTD). He will explain how the safety studies are interconnected, why they are included in the nonclinical modules, and which aspects are important to describe in the regulatory documentation. Some of you will have heard Arthur speak in 2024 at the EMWA Spring Conference in Valencia where he presented on a similar topic as part of the Expert Seminar Series on Nonclinical Regulatory Writing.

After the presentation, attendees will be encouraged to ask questions and provide input. We hope you’ll also share your own experiences, whether that is as a freelance writer, or working as a regulatory writer at a sponsor or CRO.

Arthur Noach is nonclinical expert and senior consultant at Venn Life Sciences in Breda, the Netherlands. With over 25 years of experience in the pharmaceutical industry, he specializes in designing the package of nonclinical studies to be performed prior to starting clinical studies and beyond, based on international guidelines for small molecules, biologics and vaccines. He has extensive experience in writing the nonclinical sections of briefing books, Investigator Brochures and IND modules (eCTD format). He is also a consultant and principal investigator for pharmacokinetic and toxicokinetic studies performed at Venn, for both non-GLP and GLP studies.

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