Course description
Regulatory and Related Activities Through the Lifecycle
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of a variety of topics of importance to the maintenance of the commercial and regulatory health of their company's medical devices once they have been successfully placed on the market. Topics include advertising, data protection and privacy, patents and IP, health technology assessment and reimbursement, environmental legislation and standards, relationships with distributors, own-branders, authorised representatives, trade association and regulatory bodies, product supply and logistics, product liability law, unannounced audits and good regulatory practice.
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Suitability - Who should attend?
This course is suitable for
- Students of the TOPRA MSc programme
- participants from the regulatory affairs industry who wish to develop their knowledge of the regulatory and related activities through the lifecycle
- participants from allied industries who wish to have a comprehensive understanding of the subject
Outcome / Qualification etc.
Benefits to participants
- Demonstrate the ability to critically analyse the legal, regulatory and quasi-regulatory requirements applying to medical devices
- Apply good regulatory practice particularly when interacting with regulatory bodies, including critically appraising communications
- Make recommendations about how to prepare for unannounced audits
- Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non specialist audiences
- Demonstrate a critical understanding of the factors required to maximise the success of a medical device
- Understand the importance of intellectual property, data protection and product liability and judge when legal advice is required
- Demonstrate a critical understanding of health technology assessment and reimbursement
- Critically evaluate the application of environmental legislation and standards to medical devices.
Expenses
The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP