PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Wednesday, 01 April 2020

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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