Module 3 - Regulatory Requirements for a New Active Substance: Quality - 7FHH1140

Regulatory Requirements for a New Active Substance: Quality

Next course: January/February 2022

To enable students to understand quality data requirements in the pharmaceutical regulatory environment so they can address practical regulatory questions in this area and offer advice to colleagues.

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 the nonclinical study reports and summaries.

Good content, well delivered."

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.

Focus on nonclinical and drug targets? Consider:

• Module 2: Regulatory Strategy for a New Active Substance: Nonclinical Development
• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

Expanding your options? Consider

• Module 1: Strategic Planning in Regulatory Affairs
• Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
• Module 11: The US Regulatory Environment
• Module 19: Regulation of In vitro Diagnostic Medical 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.