Course description
The size of the medical device market has expanded over recent years and this trend is forecast to continue.
This course 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.
Upcoming start dates
Upcoming start dates
Suitability - Who should attend?
- Anyone involved in regulatory affairs for medical devices
- Anyone new to the region
- Anyone interested in an update on recent developments
Outcome / Qualification etc.
- Understandmedical devices and their classification
- Clarifyprocedures for company and product registration
- Discussrecent developments in the region
- Meet, network and shareexperiences with other industry colleagues
- 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 judgments 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
Training Course Content
Day 1
The medical device markets
- Markets and Culture
- Healthcare
- Business culture
Day 2
Regulatory environment and characteristics
- General regulatory requirements
- Company and product registration
Day 3
Key documents needed
- Basic structure of a dossier
- Regulatory summary
Day 4
Management of adverse incidents
- Definitions: what is reportable, the reporting
- process and investigation
- Corrective action
- Periodic safety update reports – how to manage this requirement
Day 5
Intellectual Property Law
- Advertising and Promotional Issues
- Data Privacy & Protection Freedom of Information and transparency
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