Module 2: Regulatory Strategy for a New Active Substance: Nonclinical Development

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Enables students to understand the practical and legislative requirements for the nonclinical phase of global drug development. It explores regulatory issues that are likely to arise and provides advice and discussion around solutions to such situations.

Overview

This module is designed to develop and deepen regulatory professionals’ understanding of all aspects of the nonclinical development for a new active substance. It examines the nonclinical regulatory requirements imposed on drug development, the processes of preparing documentation for the nonclinical dossier, including considerations for nonclinical study reports and summaries.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Develop a systematic understanding and a critical awareness of the practical aspects of nonclinical development, types and design of nonclinical safety studies and pharmacokinetic requirements in the context of the nonclinical research phase of drug development
  • Demonstrate a comprehensive understanding of the nonclinical regulatory requirements, nonclinical guidelines and other requirements for running nonclinical drug safety studies
  • Have a conceptual understanding of the legal and ethical aspects of nonclinical research and the importance of critical evaluation of the study designs and data generated during research on medicinal products.

Skills and attributes

Successful students will typically:

  • Demonstrate the ability to critically analyse the nonclinical regulatory documentation and guidelines for the nonclinical part of drug development.
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences
  • Critically appraise and evaluate communications from regulatory bodies and research publications covering the nonclinical data.

Focusing on CMC and formulation? Consider:

  • Module 3: Regulatory Requirements for a New Active Substance: Quality
  • Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
  • Module 7: Regulatory Strategy for Established Active Substances
  • Module 8: Data for Abridged Applications and Specialised Products

Expanding your options? Consider:

  • Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies
  • Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
  • Module 10: Leadership and Strategic Management in Regulatory Affairs
  • Module 18: Drug-device Combinations and Other Technologies