ABHI/BDIA Seminar: Virtual Manufacturing - MHRA Guidance Explained
10:30 AM - 15:15 PM
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) recently published its final guidance on Virtual Manufacturing (previously known as ‘own brand labelling’). The guidance means that a company placing a medical device on the market under its own name assumes the responsibility of the manufacturer - with all that entails. This includes holding the full technical documentation, irrespective of who manufactured the product.
Virtual Manufacturers have until 1 September 2017 to assemble all the necessary documents.
This joint seminar between ABHI and BDIA will provide clarification on the interpretation of Virtual Manufacturing and will guide companies as to how they can manage those processes. With guest speakers from MHRA, Notified Bodies and Industry, this highly interactive seminar is an ideal opportunity to interact with the authors of the document and those who will be enforcing it.
Our speakers include:
- Graeme Tunbridge, Group Manager - Devices Regulatory Affairs, MHRA
- Dhruti Patel, Senior Regulatory Affairs Manager, MHRA
- Rob Higgins, Senior Auditor/Regulatory Affairs Specialist, MHRA
- Mary Ryan, QA/RA Director, Penlon Ltd
- Martin Penver, Global Operations & Technical Manager - Medical Directives, LRQA
Procurement, Regulatory and International issues are critical to our future success and the association brings enormous value in these key areas.Simon Talbot (Managing Director P3 Medical Ltd )