Thursday, 15 November 2018
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. Moreover, the NEPAD Planning and Coordinating Agency designated the MCAZ as a Regional Centre of Regulatory Excellence (RCORE) in product evaluation and registration, clinical trials oversight, and quality assurance and quality control of medicines and other health products under the African Medicines Regulatory Harmonization Programme (AMRH).
Most NMRAs on the continent face limited availability of human resources in terms of sufficient number, technical ability, and experience. Developing a critical mass of regulatory experts will have compounding beneficial effects on other regulatory interventions to improve access to quality, safe, and efficacious medicines.
MCAZ is galvanizing its expertise gain over the years, ranging from training and hosting personnel from other NMRAs, being a founding NMRA of the regional initiative to collaboration in medicines registration in the region, known as ZAZIBONA and its expertise gained through participation in various WHO assignments on the continent, to provide structured competence based training programmes in medicines regulation.
The objectives of the training programmes are:
The training programmes are specifically designed to meet the objectives through practical hands-on experiential learning, and competence based programmes using innovative instructional, teaching methods and tools to develop outstanding regulatory science professionals to ensure effective medicines regulation in Africa. The competence system and the fellowship programme are designed in line with the proposed Guide for Africa Medicines Regulatory Professionals Fellowship Programme (Guide for FP).The programme design includes foundation level covering all the regulatory functions. Presently, MCAZ provides specialisation training in the three areas for which it is designated as RCORE by NEPAD through one to two-week short courses and competence based fellowship programme.
The fellowship and the professional courses are designed with flexible pathways with various entry points to enable regulatory science professionals with relevant work experience or other relevant qualifications to further their skills and professional development. Similarly, the exit options are flexible to enable individualisation of the training needs of regulatory science professionals. Moreover, the flexible pathways allow each individual to customize their own professional & skills development.
The Regulatory Science Fellowship Programme is proposed as part of developing leadership and talent in the field of regulatory science. The foundation fellowship is the entry level in regulatory science. The aim of the foundation level is to equip entry-level regulatory science professionals with the basic knowledge and practical experiential learning on the functions of a medicine and health products regulatory authority in discharging its mandate.
MCAZ offers specialization fellowship in three areas, product evaluation and registration, clinical trials oversight and QA/QC of medicines and medical devices under the NEPAD Planning and Coordinating Agency RCORE programme.
MCAZ with the Institute of Continued Health Education (ICHE), College of Health Sciences, University of Zimbabwe will offer core short courses covering product evaluation and registration, clinical trials oversight and QA / QC. The aim of the short courses is to equip regulatory science professionals specializing in these three areas with the requisite competencies.
Competence based training programme is focused on review of generic product applications, thus it is offered in two areas (1) Quality – CTD Module 3, and (2) interchangeability (bioavailability / bioequivalence) – CTD Module 5.
The training on Quality (Level I) covers the following core modules and is offered once every year in of each year:
a) Overview of Medicines Regulation
b) Quality – Active Pharmaceutical Ingredient (API)
c) Quality – Finished Pharmaceutical Product (FPP)
d) Scale-up and post approval changes
As a competence based training programme, participants are expected to satisfactorily complete at least three (3) reviews each for API and FPP. The duration of the training is six weeks consisting of two weeks theory and case studies, and four weeks on actual dossier reviews.
The training on Interchangeability (BA/BE) (Level I) covers the following core modules and is offered once every year in Sept/Oct of each year:
a) Bioavailability/ bioequivalence
b) Dissolution Studies
c) Product Information & Technical writing
As a competence based training programme, participants are expected to satisfactorily complete at least three (3) reviews each for bioequivalence studies; BCS based biowaivers and biowaiver for additional strengths. The duration of the training is six weeks consisting of two weeks theory and case studies, and four weeks on actual dossier reviews.
Click to download MCAZ RCORE TRAINING BROCHURE
Advanced competence training(Level II) in product evaluation and registration will be offered once every two years.
Advanced Modules in Quality are as follows:
a) Advanced Drug Delivery Systems
b) Biotech Products
c) Quality by Design
d) Analytical & Process Validation
e) Development Pharmaceutics
f) Drug Master File (DMF)
NB: Participants are also expected to complete the basic GMP course for advanced competence training (level II) in Quality assessment.
Advanced Modules in bioavailability / bioequivalence are as follows:
a) Bioanalytical Methods & Validation of Bioanalytical Methods
b) Statistical Methods in Bioequivalence
NB: Participants are also expected to complete the basic GCP and ethical conduct of research and clinical trials and data management courses for advanced competence training (level II) in Bioavailability / bioequivalence.
a) Good Clinical Practice (GCP) & Ethical Conduct of Research
b) Clinical Trials and Data Management
The specialization modules will be offered once every year beginning in 2015. The following are the modules on offer:
a) Instrumentation and Technique
b) Media, Reagents and Solution Preparation
c) Safety and Hazardous Waste/Infectious Waste
d) Methodology and Methodology Sources
e) Quality Assurance and Good Laboratory Practices
f) Pathogens and Indicator Organisms
g) Condom conformity assessment testing
h) Glove conformity assessment testing
i) Basic Analytical Techniques in Chemistry
j) QMS awareness training
Advanced Modules will be offered once every year.
Advanced Modules in Analytical Testing are as follows:
a) Sterility of Medicines and Medical Devices
b) Microbiological Examination of Non-sterile products/Oral herbal medicinal products
c) Antimicrobial Effectiveness Testing of Medicines
d) Microbiological Assays of Antibiotics
e) Bacterial Endotoxin Testing
f) Validation and Qualification of Equipment and Analytical Methods
g) Evaluation of analytical method validation data
h) Environmental Monitoring
i) Spectrophotometric Techniques
j) Chromatographic Techniques
k) Advanced Techniques in Chemistry
l) QMS development and implementation- CGMP, ISO/IEC17025
m) Hands- on experience of pharmaceutical analysis.
For more information on the training services contact Training Coordinator, at This email address is being protected from spambots. You need JavaScript enabled to view it.; phone +263 4 708 255
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