Welcome to this self-paced / self-study version of “A Primer for Clinical Assessors within African Regulatory Agencies” course! These training materials have been presented several times in a course that is led by a team of international and local subject matter experts – check the hyperlinks below for reports after each successful conclusion of that University certified program. The course materials were set up when some of us realised that there was a critical shortage of skilled regulatory professionals and a paucity of training opportunities – especially on the topics related to the clinical sections of regulatory dossiers.

Lesson 1: Welcome to the course
Lesson 2: Molecule to Market – Overview of Drug Discovery & Development
Lesson 3: Clinical Data for Regulation and Product Licensing
Lesson 4: Collection of Clinical Data – What and How
Lesson 5: Interpretation and Reporting of Clinical Data
Lesson 6: Regulatory Assessment of Relevance of Clinical Data for Indication, Licence and Label
Lesson 7: Assessment of Validity and Acceptability of Clinical Data for Regulation
Lesson 8: Clinical data clinical endpoints and outcomes
Lesson 9: Critical Review of Clinical Data for Efficacy and Safety
Lesson 10: Clinical Data: Safety, Risk Management and Mitigation
Lesson 11: Marketing Authorisation and Product Information
Lesson 12: Clinical Data for Regulatory Communications
Lesson 13: Regulators and Sponsors as Partners for Patient Benefit
Lesson 14: Biosimilars

Students are encouraged to self-enroll in the course and access each lesson as standalone, on-demand training.