- 01 Mar 2018
- All day
- Live Event
2 Swan Lane
Fieldfisher's life sciences sector group is pleased to share their solutions to the issues raised by the many recent changes to the laws, regulations and practices which affect the sale of medical devices. This highly practical one day workshop will provide you with tips for adapting to and embracing these challenges, as we share our learnings on a range of topics including:
MDR/ IVDR: Beyond the regulatory team: Understanding how the new regulations will affect contractual relationships and the company's sales and promotional practices.
GDPR: A focus on some of the issues particular to the medical devices industry.
Brexit: Preparing your business for Brexit.
Notified Bodies: Tools to manage your relationship: Challenging their actions and decisions.
Procurement: Strategies in challenging decisions.
Competition Law: Pricing, bundling and working with the NHS.
Digital Medical Devices regulatory position: Medical Device or accessory? Wellness or Medical Device app?
After lunch we will look at laws across other countries, with additional perspectives from France, Germany and the US:
- Meeting transparency requirements across Europe
- Advertising medical devices across Europe
- A primer on the US regulation of medical devices and insights into recent and future regulatory changes presented by Jeffrey N. Gibbs of Hyman, Phelps & McNamara, P.C Washington.
Date: Thursday 1 March 2018
- 08.30 - Registration
- 09.00 - Start
- 13.00 - Lunch
- 14.00 - Start of International perspective section
- 17:00 - Close followed by a drinks reception