The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.

This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.

This audio conference covers:

• An overview of recent developments designed to attract medical device studies to the UK
• The submission process for Research Ethics Committee (REC) approval in the UK
• The submission process for regulatory approval in the UK
• The submission process for institution approval, as well as other UK approval processes
• Where to go and who to contact for information

About the speaker:

Janette Benaddi, RGN, BSc, MICR, CSci, CDir is CEO of Medvance Ltd, providing clinical research and regulatory consulting services to the medical device and healthcare industries. She has over 20 years of experience managing pre- and post-market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance 14 years ago, she worked in Paris for a medical device consultancy group as project director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products.

Janette is a registered nurse, has a BSc in Management Studies, a Diploma in Company Direction, a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She is the Chair of the Board of Directors at The Institute of Clinical Research in the UK and is also currently Chairman of the Knowledge Transfer Network Clinical Studies Special Interest Group. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies.

Who should attend?

• Clinical Managers and Directors
• Clinical Study Managers
• Clinical Research Associates
• Regulatory Affairs Managers and Directors