This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course distance-learning activities will also be available for the interested participants.
On successful completion of this Module the student should be able to: Describe the background to the development of medicines regulation at a global level & discuss the similarities & differences between the current regulatory systems in the major regions (EU, US, Japan, ROW). Describe the role & importance of the practical input from expert international bodies including WHO, CIOMS, WMA, in the oversight of medicines regulation. Critically review & evaluate the similarities & differences in legislation relating to drug development in the different regions & explain the impact on the various stakeholders, including regulators, pharmaceutical companies, healthcare professionals & patients. Compare & contrast the legal requirements regarding the provision of product information between the major regulatory regions. Synthesise the post-marketing activities undertaken by the marketing authorisation holder & the regulatory agencies, & their associated interaction, as part of the life-cycle management of an authorised medicine. Explain the background to the development of the International Conference on Harmonisation (ICH) & evaluate its role & main activities, including the Common Technical Document (CTD). Describe & appraise the medicines legislation underpinning therapeutic areas, including paediatric use, orphan drugs, advanced therapies & biosimilars in the EU & other major regions. Explain the principles & practical application of the Medical Devices regulations in the EU & other major regions.