The MCAZ offers training services for new and seasoned regulators from national medicines regulatory authorities (NMRAs), regulatory affairs personnel from the pharmaceutical industry, and people from academia.
The course is designed as a six-week competency based training program. The training has three parts (a) readings, and assignments for 3 weeks, (b) intensive one-week training on the key principles of interchangeability, application of concepts of ethics, clinical conduct, study designs, pharmacokinetics, statistics, bioanalysis and method validation, in bioequivalence (BE), and (c) demonstration of competence through review of actual bioequivalence data submitted for applications for registration of medicines. The second part is only applicable to participants working for medicines regulatory authorities or equivalent, or those in academia.
The course format and delivery has been carefully selected to ensure that completion for the course simulates the real life of a regulatory officer responsible for performing the product assessments or regulatory officer at pharmaceutical or clinical research organization responsible for quality assurance and compliance, regulatory filing of study results. The goal is to ensure successful conduct of bioequivalence studies meeting regulatory requirements and / or appropriate review of the bioequivalence submissions for registrations of medicines. As such, two key principles are applied; competence based approach (rather than knowledge and memory based approach) and participant centered learning.
The objective of this course is to train and equip participants with the requisite knowledge and skills relating to demonstration of interchangeability to enable them to evaluate data to demonstrate interchangeability through bioequivalence for registration of medicines.
By the end of this course, participants should be able to:
The course content is divided into three components as follows:
B. Scientific Principles