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 working in Industry responsible for compilation, screening and pre-submission evaluation of dossiers. This course will give an overview of the process of drug development and the various phases of clinical trials undertaken. This course will give assessors and industry a better understanding the process of bringing a new medicine onto the market. A certificate of completion will be awarded at the end of the training.
Topics offered – phase 1, II, III and IV clinical trials
Duration: 5 days
*10% discount for early bird registration Course Fee: USD 500
Medicines Registration (Marketing Authorisation)
This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on medicines registration. This course will also equip regulatory affairs personnel working in Industry responsible for compilation, screening and pre-submission evaluation of dossiers. This course will give an overview of medicines regulation and requirements for compilation of good quality dossiers. Knowledge gained from this course will result in shorter review cycles and faster registration of medicines. A certificate of completion will be awarded at the end of the training.
Topics offered – Overview of medicines regulation, CTD format, API & FPP Specifications, Common deficiencies (API, FPP, BE), pharmaceutical development considerations for generics, Stability, Selection of comparator products, product lifecycle management, regulatory harmonization initiatives
Duration: 5 days
*10% discount for early bird registration Course Fee: USD 500
Active Pharmaceutical Ingredient (Drug Substance) of small Molecules
This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on section 3.2.S of the CTD dossier. This course will also equip regulatory affairs personnel working in Industry responsible for compilation, screening and pre-submission evaluation of dossiers. For regulators, the course fee includes an additional one week hands on training assessing dossiers at the Medicines Control Authority of Zimbabwe under the guidance of experienced assessors. A certificate of completion will be awarded at the end of the training.
Topics offered – Overview of medicines regulation, API Assessment Principles, General Information of the API, Manufacture, Characterisation, Control of the API, Reference Standards/Materials, Container Closure System, Stability, Common deficiencies.
Duration: 5 days
*10% discount for early bird registration Course Fee: USD 500
Active Pharmaceutical Ingredient (Drug Substance) of small Molecules
This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on section 3.2.S of the CTD dossier. This course will also equip regulatory affairs personnel working in Industry responsible for compilation, screening and pre-submission evaluation of dossiers. For regulators, the course fee includes an additional one week hands on training assessing dossiers at the Medicines Control Authority of Zimbabwe under the guidance of experienced assessors. A certificate of completion will be awarded at the end of the training.
Topics offered – Overview of medicines regulation, API Assessment Principles, General Information of the API, Manufacture, Characterisation, Control of the API, Reference Standards/Materials, Container Closure System, Stability, Common deficiencies.
Duration: 5 days
*10% discount for early bird registration Course Fee: USD 500