PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Saturday, 24 October 2020

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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
 

 


 

FINISHED PHARMACEUTICAL PRODUCT (DRUG PRODUCT) OF SMALL MOLECULES

This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on assessment of section 3.2.P 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, FPP Assessment Principles, Description and composition of the FPP, Pharmaceutical Development, Manufacture, Control of Excipients, Control of the FPP, Reference Standards/Materials, Container Closure System, Stability, Common deficiencies.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 500
 

 



BIOEQUIVALENCE

This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on assessment of the bioequivalence section 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 – Introduction to bioequivalence, Study Products, Ethics and clinical trial conduct, Bioequivalence Study Designs, Pharmacokinetics, Statistical methods in bioequivalence, Sample size calculation, Introduction to Statistical analysis and considerations, Introduction to Bioanalytical method validation, Introduction to BCS based biowaivers. 

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 500
 

 

 


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: 5 days
*10% discount for early bird registration
Course Fee: USD 300
 

 


SPECIFIC DOSAGE FORMS

This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on assessment of specific dosage forms. 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 – Introduction to specific dosage forms, Sterile dosage forms, Inhalation products, Topical dosage forms, controlled release dosage forms

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 500
 

 


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
*10% discount for early bird registration
Course Fee: USD 300
 

 


BIOSIMILARS

This course is targeted at entry level/level I assessors or experienced assessors wanting a refresher on assessment of specific dosage forms. 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 – Introduction to biosimilars, Quality aspects e.g production, comparability exercise, Non-clinical aspects e.g animal studies, in-vitro tests, Clinical aspects e.g pharmacokinetic studies, pharmacodynamics studies, efficacy studies e.t.c,  Insulin and erythropoietin case studies.

Duration: 5 days
*10% discount for early bird registration
Course Fee: USD 500
 

 

 


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
*10% discount for early bird registration
Course Fee: USD 300