PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Saturday, 14 December 2019

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.

Course Format

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.

Course Objectives:

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.

Learning Outcomes

By the end of this course, participants should be able to:

  1. Articulate the scientific & regulatory basis and assumptions for demonstration of interchangeability,
  2. Demonstrate knowledge, understanding and application of key principles of ethics, good clinical practice (GCP), biopharmaceutics, pharmacokinetics, statistics and bioanalysis in bioequivalence,
  3. Analyse and draw conclusions on available data to demonstrate bioequivalence based on application of relevant requirements in applicable regulatory guidelines
  4. Review and write a scientific assessment report on data submitted in the application for registration of a medicine in accordance with applicable regulatory guidelines

Course content

The course content is divided into three components as follows:

A. Foundation:

  1. Regulatory requirements for registration of medicines
  2. Demonstration of interchangeability

B. Scientific Principles

  1. Good Clinical Practice (GCP)
  2. Biopharmaceutics
  3. Pharmacokinetics
  4. Statistical methods in bioequivalence
  5. Bioanalytical methods
  6. Bio analytical methods validation
  7. Comparative dissolution

C. Application

  1. Study designs
  2. Study conduct
  3. Data analysis