In partnership with NUS

Academy of GxP Excellence since 2009

Objective

 

The course provides an overview and an in-depth understanding of Regulatory Affairs in Asia and the Agency review expectation of the dossier for CMC section. The course focus on the comparison of regulatory requirements in Asia region with emphasize on the GCP, GMP, DMF system, which helps in developing regulatory submission strategy.  The course teaches in-depth of the organization of the CTD, detailed information and discussion related in each element in the drug substance and drug product from reviewer’s perspective. 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

 

  • Professionals new to Regulatory Affairs who wants to gain a foundation

  • Regulatory Affairs Professionals who wants to refresh and update their knowledge

  • Professionals in the Pharmaceutical industry who wants to understand Regulatory Affairs

 

Learning Outcome

 

Upon completion of this course the attendees will be able to:

  1. Understand the regulatory environment and harmonization efforts for pharmaceuticals in Asia

  2. Compare between the pre-market and post-market regulatory requirements

  3. Understand regulatory, scientific and technical options for successful lifecycle management through CMC and regulatory strategy.

  4. Gain tips and knowledge in interacting with Health Authorities

  5. Gain insights from interactive Q&A

  6. Promote excellence in your regulatory affairs profession

 

Course Outline

 

With reference to the major Asian and ASEAN countries:

  1. International Conference on Hamonisation (ICH)

  • ICH Background

  • ICH Products

  • ICH implementation in various jurisdictions

 

   2. Different Regulatory Requirements in APAC Regions

  • ICH CTD vs ACTD

  • Local Clinical Trial and GCP site inspection

  • GMP system

  • DMF system

  • Packaging Label and language

  • Interactive Q&A

 

   3. CTD Module 3 (Quality Section) --- Agency review expectations

  • Requirements for the Drug Substance

  • Requirements for the Drug Product

  • Analytical Methods and Validation

  • Control of the product

  • Container Closure System

  • Specifications

  • Reference Standards

  • Stability

 

  4. Interaction with Health Authorities

  • HA queries and how to manage response

  • Tips in successful interaction with Health Authorities

 

  5. Conclusions

  • Interactive Q&A

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