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.
Product Evaluation and Registration
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.
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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.
Clinical Trials Oversight
a) Good Clinical Practice (GCP) & Ethical Conduct of Research
b) Clinical Trials and Data Management
Quality Assurance and Quality Control of Medicines & Medical Devices
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.