MSc in Regulatory Affairs: 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 advice on the suitability of preclinical programmes from a regulatory perspective.

Learning outcomes

• Students will gain an insight into the research processes used to identify and select new candidate compounds.
• Students will be able to describe the types and designs of preclinical safety studies generally required to successfully develop a new product. In addition, they will be able to apply this knowledge in assessing the regulatory acceptability of preclinical development programmes.They will be able to advise on the format and content as well as submission strategy for such information.
• Students will gain an understanding of pharmacokinetic principles and how these are applied to link the preclinical and clinical components of pharmaceutical development.
• Students will be able to describe the differing types of preclinical reports and summaries required through development to filing.
• Students will gain an insight into the Regulatory Authorities' views of the preclinical dossier and the influence of ICH.

Outline of Module topics

• The real cost of a new active substance – an insight into trends in the pharmaceutical industry which are causing development costs to rise
• The identification of a candidate product and the planning of its development
• The design of, and data interpretation from, the key safety studies (pharmacology, toxicology, mutagenicity, carcinogenicity and reproduction toxicology) including requirements for Good Laboratory Practice
• An introduction to the key concepts of pharmacokinetics and toxicokinetics and how these are applied during development
• The key regulatory requirements and guidelines covering safety pharmacology, toxicology, mutagenicity, carcinogenicity and reproduction toxicity testing and how to apply these
• The role of the Regulatory Affairs department throughout the preclinical phase to filing
• The Regulatory Authorities' view of the preclinical dossier and the influence of ICH
• The structure, content and focus of key preclinical components of the regulatory submissions including CTX, IND, NDA, MAA and CTD

Links with other modules

• Module 4 covers the progression of clinical trials in relation to the toxicity programme.
• Module 9 covers the preclinical requirements for biotech products.
• Module 8 covers the toxicological data that may be needed for line extensions of marketed products.