Objective

 

The course provides an overview and in-depth understanding of ICH regulations, to understand the expectations of regulatory agencies when reviewing the ICH CTD dossier. The course provides detailed information and discussion related to each element in the drug substance and drug product from reviewer’s perspective and will focus on drug development, analytical method validation, impurities, specification and stability. The course also provides discussions specific to solving regulatory issues and interacting with health authorities.  Interactive Q&A and exercises will be conducted at the end of each section.  Whether you are new to the profession or someone who wants to refresh their knowledge in Regulatory Affairs, this course will help you enhance your skills in executing your functions.

 

Who should attend?

 

  • Regulatory Affairs Professionals involved in preparing/reviewing/authoring CMC documents

  • Regulatory Affairs Professionals involved in regulatory filing

  • Professionals who want to refresh and update their knowledge in CMC and ICH Principals

 

Outline

  • International Conference on Harmonization (ICH)

    • ICH Introduction,

    • ICH Guidelines

    • Implementation in various jurisdictions

  • Requirements for the Drug Substance

    • S.2 Manufacture - ICH Q11

    • S.3 Characterization

    • S.4 Control of the Drug Substance- ICH Q2, Q3, Q4 and Q6

    • S.5 Reference Standards

    • S.6 Container Closure System

    • S.7 Stability - ICH Q1

 

  • Requirements for the Drug Product

    • P.2 Pharmaceutical Development—ICH Q8

    • P.3 Manufacture

    • P.4 Control of Excipients- ICH Q2, Q3, Q4 and Q6

    • P.5 Control of the Drug Product- ICH Q2, Q3, Q4 and Q6

    • P.6 Reference Standards

    • P.7 Container Closure Systems

    • P.8 Stability - ICH Q1

 

  • Quality Overall Summary (Module 2 of CTD)

  •  Interactions with Health Authority

    • HA queries and how to manage response (case studies)

    • Tips in successful interaction with Health Authorities

    • Interactive Q&A

In partnership with NUS

Academy of GxP Excellence since 2009