Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development

Next taking place in Nov - Dec 2024.

Covers regulatory strategies for all aspects of global clinical research, as well as addressing practical regulatory issues in this area.

Overview

This module is designed for regulatory professionals to increase their understanding of all aspects of the global clinical development regulation. It allows them to examine the regulatory requirements imposed on clinical development, the processes of preparing documentation for clinical study reports and regulatory overview summary documents, and strategic considerations for the running of international clinical trial programmes.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Possess a systematic understanding and critical awareness of the regulations and international directives pertaining to clinical development of a new medicine.
  • Show a critical awareness of the clinical programme strategies, which can be employed during development and registration of a new medicine, and exhibit effective regulatory leadership throughout clinical development and the registration of a new medicine.
  • Display a comprehensive understanding of the EU legislation on the different aspects of clinical development, and of the procedures and regulatory requirements for clinical trial reports, clinical overview and summary documents for optimal product labelling.
  • Evaluate methodologies and develop critiques of the medical, statistical, economic and operational aspects of clinical trial programmes.

Skills and attributes

Successful students will typically:

  • Demonstrate the ability to critically analyse the legal documentation relating to global operational clinical trial programme considerations of clinical research
  • 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 global clinical research communications from regulatory bodies and research publications.

Focusing on global clinical development? Consider:

  • Module 2: Regulatory Strategy for a New Active Substance: Nonclinical Development
  • Module 5: Regulatory Control of Clinical Operations
  • Module 6: Regulatory Strategy: From Development to the Market Place
  • Module 10: Leadership and Strategic Management in Regulatory Affairs
  • Module 11: The US Regulatory Environment
  • Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

Expanding your options? Consider:

  • Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
  • Module 11: The US Regulatory Environment
  • Module 18: Drug-device Combinations and Other Technologies
  • Module 19: Regulation of In vitro Diagnostic Medical Devices
  • Module 20: Regulation of Electrical, Electronic and Software Devices