2023 training dates to be announced
The Authority was designated a Regional Centre of Regulatory Harmonisation under the African Medicines Regulatory Harmonisation (AMRH) Initiative of the African Union and the NEPAD Agency in 2014, offering training and services for new and seasoned regulators from national medicines regulatory authorities (NMRAs), regulatory affairs personnel from the pharmaceutical industry, and people from academia.
The areas of ReCoRE designation included:
- Medicines Registration
- Pharmacovigilance and Clinical Trials
- Laboratory Testing of medicines
The MCAZ ReCORE Mission
To provide world class Medicines Regulatory Training Expertise so as to ensure affordable, quality, safe and efficacious medicines for the African Continent.
The MCAZ ReCORE Vision
To have an adequate pool of knowledgeable well trained medicines regulators for Africa and to grow the MCAZ brand through the RCORE activities.
Goals/ objectives of the MCAZ ReCORE:
- To ensure that Africa has access to safe, quality, efficacious and affordable medicines through regulatory excellence (overarching goal)
- To nurture and develop technical and managerial competencies to ensure effective medicines regulation in Africa.
- To build and develop the same competencies as stipulated in the NEPAD RCORE Framework at MCAZ as a pilot and use the pilot as a solid example
- Provision of academic, technical and managerial training to regulators and analysts on this regulatory function;
- Skills enhancement through hands-on training, twinning and exchange programmes among National Medicines Regulatory Agencies (NMRAs)
- Implementation of national / regional programmes in support of coordinations of activities between official medicines control laboratories
- Exchange information on work programmes to optimise the use of expertise, laboratory resources and analytical data available
Fellowiship in Regulatory Science
Short Courses
Online Courses
Fellowiship in Regulatory Science
The Medicines Control Authority of Zimbabwe (MCAZ) Regional Centre of Regulatory Excellence (ReCORE) in partnership with the European and Developing Countries Clinical Trials Partnership (EDCTP) is offering a 2-year fellowship in regulatory science to 8 – 10 assessors working in African medicines regulatory authorities (MRA). Fellows will be admitted in two groups, the first in 2019 and the second group in 2020. The fellowship is .designed to provide both theoretical and experiential training for regulatory professionals in African countries. The ultimate goal is address challenges in regulatory agencies due to inadequate and under skilled human resources as well as to develop strong research capability in regulatory science in low- and-middle income countries.
The fellowship will involve completion of short courses through block release training at the MCAZ / University of Zimbabwe (UZ), completion of the summer course and winter mini-conference at the Utrecht-WHO Collaborating Centre for Pharmaceutical Policy and Regulation in the Netherlands, practical work assignments, case studies, specific hours of practice (dossier assessments) over the fellowship period and a capstone project.
Deliverables;
8 – 10 competent medicines reviewers (WHO level II and III)
8 – 10 RAPS/TOPRA certified regulatory affairs professionals from African medicines regulatory agencies (MRAs)
8 – 16 Publications in regulatory science
100 Regulatory science professionals attending short courses
Short Courses
Basic Courses
DRUG DEVELOPMENT
This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher. This course will also equip regulatory affairs personnel.
Advanced Courses
QUALITY MANAGEMENT SYSTEMS AND LEADERSHIP
This advanced course is targeted at experienced assessors and regulatory affairs personnel working in industry. This course will cover leadership.
READ MORE…
Online Courses
BIOWAIVERS (Online)
This online course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on assessment of biowaivers (e.g BCS based and additional strengths). This course will also equip regulatory affairs personnel working in Industry responsible for compilation, screening and pre-submission evaluation of dossiers.
Topics offered – Brief historical overview of dissolution, Biopharmaceutical Classification System, Additional strength biowaivers,
Duration: 1 month Course Fee: USD 300
*10% discount for early bird registration
PRODUCT LIFE-CYCLE MANAGEMENT (Online)
This online course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on product lifecycle management. This course will also equip regulatory affairs personnel working in Industry responsible for product lifecycle management.g variation applications. A certificate of completion will be awarded at the end of the training.
Topics offered – Overview of a Product lifecycle, Post registration variations, scale up and post approval changes, reinstatements, retentions, periodic review of marketing authorisation/renewals
Duration: 1 month Course Fee: USD 300
*10% discount for early bird registration
REGULATORY HARMONISATION AND RELIANCE (Online)
This online course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on regulatory harmonization and reliance. This course will also equip regulatory affairs personnel working in Industry or professionals looking to start a career in regulatory affairs. A certificate of completion will be awarded at the end of the training.
Topics offered – Overview of Regulatory harmonization and reliance, AU Model Law and the African Medicines Agency, Regulatory harmonization initiatives in Africa and the world, Processes and timelines, successes and challenges.
Duration: 1 month Course Fee: USD 300
*10% discount for early bird registration