Module 3 - Strategic case studies in practice
TOPRA TRAINING COURSE MODULE 3
FEBRUARY 2021
MODULE 3 FOR REGULATORY AFFAIRS Online training / professional development for Regulatory Affairs staff
WHO IS THE COURSE FOR? This training course is intended for Regulatory Affairs and other professionals who want to refresh, explore and extend their knowledge on Module 3. Prior knowledge of Module 3 requirements is helpful, but if you are feeling a little rusty and are not sure, do not worry: the course includes some refresher sessions on the basics. WHAT AREAS WILL WE COVER? For this course we are going to concentrate on Module 3 requirements for OTC medicines: solid, liquid, and semi-solid formulations. We will look at: ? The challenges of managing old dossiers for new submissions, including ones that are: o licensed in from other companies o based on the old ‘Notice to Applicants’ format that have a baseline eCTD but have not been updated for some time o supported by ASMFs that need modernisation ? What to check when you are reviewing a Module 3 for a new application, including: o Gaps that are important and must be fixed o Gaps that you can live with and, if needed, can fix later ? Planning a new Module 3 for a submission ? Lifecycle management – tips and tricks for making sure your files stay up to date. HOW WILL WE LEARN? • Some tutorials • Some exercises - looking at real examples – internal and external • A case study, based on a real example • Your shared experiences of how to deal with old (and sometimes rather hairy) Module 3 files.
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