The WBG has developed a free e-training on Post-Approval Changes (PAC) to Marketing Authorizations (MA) as part of its support for strengthening regulatory systems. It aims to support efforts toward the implementation of a consistent and harmonized regulatory approach for the management of global PAC. This approach seeks to facilitate access to quality medicines and vaccines and improve health outcomes in Low- and Middle-Income countries.
This online training, based on WHO guidelines, serves as a foundation for post-approval changes and provides an overview of PAC systems, rationale, and processes. It also helps the participants familiarize with specific technical provisions for the small molecules, biotherapeutics, and vaccines. Other relevant topics such as Product Lifecycle, ICH and CTD Structure, regulatory harmonization, convergence, and reliance principles are covered as well.
This self-paced training includes two separate courses, essential and advanced. Both modules are available in English, French and Spanish.
Session 1: Introduction
Session 2: WHO Guidelines – What and Why?
Session 3: WHO Principles for Post-Approval Changes: Categorizing the Changes
Session 4: Procedures and Handling Post-Approval Changes
Session 5: Regulatory Convergence: Fostering Harmonization of the Post-Approval Changes Process
Session 1: Drug Development Overview
Session 2: The Concept of Post-Approval Changes
Session 3: Reliance Model and Prequalified Products
Session 4: Classification of Post-Approval Changes
Session 5: Procedural Guidance and Approval of PAC
Session 6: How to Navigate the Dossier and Understand the CTD Structure
Session 7: Navigating and Interpreting the WHO Guidelines
Session 8: Navigating the Guidelines - Changes to Prequalified and Multisource products
Session 9: Navigating the Guidelines - Changes to Biotherapeutics
Session 10: Navigating the Guidelines - Changes to Vaccines
Session 11: Post-Approval Changes vs. New Marketing Authorizations
Session 12: Handling (new) Information
Who can benefit from this training and how to access it:
Regulators and Policymakers via https://post-approval-changes.moodlecloud.com/
Industry, Academia, NGOs and other stakeholders via https://www.diaglobal.org/DIA-Campus/Course-Listing/
First time to access the course → Create an account/profile
Future access → Sign-in only
To encourage knowledge sharing and continuing education, we invite you to share this information with your network.
*The content of this training was developed by DIA for the WBG.