Avoid Annoying the Regulators: Getting Module 2 Right

9:20 AM - 9:45 AM

Regulatory guidance [ICH M4S(R2)] is available to support the presentation of nonclinical data for regulatory submissions such as a US IND or a more global MAA/NDA in sections 2.4 and 2.6. However, content relies on experience of presenting the data in a scientific yet concise and critical manner. This presentation will provide an insight into the pharmacology, pharmacokinetic and toxicology content making up sections 2.4 and 2.6 including “top tips” to avoid generating documentation that lacks a robust safety evaluation for the new drug candidate. It will also be shown that nonclinical/toxicologist input during preparation of documents is vital. Thus, not only does this approach avoid annoying the regulators, but good submission documentation = smooth review = delivering the drug quicker into the clinic and/or onto the market.