Module 1: Strategic Planning in Regulatory Affairs

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Enables students to understand the practical and strategic aspects of global regulatory affairs, helping them develop sufficient knowledge and skills to provide advice to their companies and contribute to regulatory strategy.

Overview

This module is designed to deepen students’ understanding of all aspects of the management of global regulatory operations and strategic planning. It examines the strategic regulatory options for planning global drug development programmes, the interactions between the companies and the regulatory agencies, the processes of preparing strategic regulatory documentation for gaining marketing authorisation and commercialisation of a product.

You can pick the different modules you want to study. This flexibility is useful as you can choose ones you do not have experience with to broaden your knowledge.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Demonstrate a systematic understanding of knowledge in, and a critical awareness of the theory and practice of global strategic planning as they relate to obtaining regulatory marketing authorisation and pricing negotiations
  • Display critical knowledge of the regulatory requirements, global legislation, regulatory authorisation and associated documentation for planning drug development programmes
  • Demonstrate an in-depth conceptual understanding of strategic plans for the regulatory approval of drug development programmes.

Skills and attributes

Successful students will typically:

  • Critically appraise and evaluate communications from regulatory bodies and research publications for the management of regulatory affairs and strategic planning in drug development
  • Demonstrate the ability to critically analyse the legal documentation and regulatory consideration 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 regarding planning regulatory strategies for drug development programmes for regulatory authorisation and marketing approval.

Focusing on clinical development? Consider:

  • Module 2: Regulatory Strategy for a New Active Substance: Nonclinical Development
  • Module 3: Regulatory Requirements for a New Active Substance: Quality
  • Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
  • Module 5: Regulatory Control of Clinical Operations
  • Module 6: Regulatory Strategy: From Development to the Market Place
  • Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products 

Expanding your options? Consider:

  • Module 11: The US Regulatory Environment
  • Module 12: Data Management and Digitalisation in Regulatory Affairs
  • Module 18 Drug-device Combinations and Other Technologies