Module 2
Regulatory Strategy for a New Active Substance: Preclinical Development
Aim
The purpose of this Module is to provide students with an understanding of the key requirements and submissions strategies associated with the preclinical development process in order to enable them to provide effective regulatory leadership within their organisations throughout the preclinical development.
Learning outcomes
- Students will describe the research processes used to identify and select new candidate compounds.
- Students will analyse the types and designs of preclinical safety studies required to successfully develop a new product. In addition, they will assess the regulatory acceptability of preclinical development programmes. They will determine the format and content as well as submission strategy for such information.
- Students will interpret pharmacokinetic principles and how these are applied to link the preclinical and clinical components of pharmaceutical development.
- Students will recognise the differing types of preclinical reports and summaries required through development to filing.
- Students will understand the Regulatory Authorities' views of the preclinical dossier.
Outline of Module topics
- The real cost of a new active substance – an insight into trends that lead to rising development costs in the pharmaceutical industry
- The identification of a candidate product and the planning of its development
- The methodology of preclinical testing
- Designing and interpreting data from key safety studies (pharmacology, toxicology, mutagenicity, carcinogenicity and reproduction toxicology) including Good Laboratory Practice
- An introduction to pharmacokinetics and toxicokinetics and how these data are applied during development
- The key regulatory requirements and guidelines covering safety pharmacology, toxicology, mutagenicity, carcinogenicity and reproduction toxicity testing
- The role of the Regulatory Affairs department throughout the preclinical phase to filing and life-cycle management
- The Regulatory Authorities' view of the preclinical dossier
- The structure, content and focus of key preclinical components of the regulatory submissions including IMPD, IND, NDA, MAA and CTD.