Module 5 - Regulatory Control of Clinical Operations - 7FHH1143

Regulatory Control of Clinical Operations

Next course: May/June/July 2022

Examine the practical regulatory aspects of global clinical research and potential regulatory issues likely to arise during clinical programmes with an emphasis on providing effective advice and solutions in such circumstances.

Overview

This module is designed for regulatory professionals to develop and deepen their understanding of all aspects of the regulation of clinical operations. It allows them to understand the regulatory requirements imposed on clinical research, the processes of preparing documentation for clinical trial authorisation and the ethical and legal considerations. In particular, it will impart the ability to critically appraise actions and report recommendations on the appropriateness of strategies in clinical research.

Top speakers, relevant content and good organisation."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Develop a systematic understanding and a critical awareness of the practical aspects of good clinical practice (GCP), good manufacturing practice (GMP), ISO 14155 and pharmacovigilance in the context of clinical research
• Critically evaluate the current regulatory requirements, EU clinical directives/regulations, clinical trial authorisation and associated documentation for both pharmaceuticals and devices
• Demonstrate in-depth knowledge and comprehensive understanding of the legal and ethical aspects of clinical research and importation of medicinal products.

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 regulatory operations in clinical research? 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 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 12: Data Management and Digitalisation in Regulatory Affairs

Expanding your options? Consider:

• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• 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

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.