The 5th Medical Devices Symposium

Compliance for today and planning for tomorrow

Organised in conjunction with Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

This important annual Medical Device Symposium is now recognised as a key event in the European calendar of all those working in the medical device arena.

Aim

This annual Symposium is for all those involved with Veterinary medicines and brings together representatives of industry, notified bodies and regulatory authorities to discuss and understand today’s compliance requirements, and debate the future plans for medical device regulation. This is the key annual European regulatory forum for all those involved in the medical devices sector and aims to bring you all the latest information and importantly what is coming over the horizon. There will also be ample time to network in the breaks and view services from exhibitors in the industry and the regulatory bodies.

Who should attend

All those working in the devices industry, notified bodies and regulatory authorities and those in the pharmaceutical industry who have medical devices or use devices in combination with their medical products.

Programme includes (subject to change):

• Keeping Compliant – Everyday issues to focus on covering:
• Clinical Data and Clinical Trails: A Case Study
• Vigilance, Device Bulletins and Post Market Surveillance
• Counterfeiting: A constant problem for industry, regulators and the patient
• The First Six Months of Directive 2007/47/EC covering:
• The Impact of 2007/47/EC – A Competent Authority View
• Practical Implementation of 2007/47/EC by the Medical Device Industry
• Working with Manufacturers and Competent Authorities: The Notified Body experience with 2007/47/EC
• Planned Directive 2007/47/EC Initiatives covering:
• Impact of EUDAMED on all Parties in the Regulatory Cycle
• e-Labelling
• The Future Plans for Medical Device Regulation covering:
• EU Re-cast MDD, IVD and AIMD

Speakers include

• Richard Gutowski, European & Compliance - Head, MHRA, UK
• Neil Adams, Director of Healthcare Operations, BSI, UK
• Sue Ludgate, Director of Devices Clinical, MHRA, UK
• Tony Sant, Group Manager, Device Technology & Safety, MHRA, UK
• Bruce Petrie, Compliance Unit Manager (Medical Devices), MHRA, UK
• David Pulis, Assistant Head, Regulatory Affairs Directorate, Malta Standards Authority, Malta
• Hilde Viroux, Asst. Director EU Medical Device RA, Alcon Laboratories, Belgium
• Suzanne Halliday, Orthopaedic & Dental Team Leader, BSI, UK
• Dario Piravano, Consultant Regulatory Affairs, Eucomed, Belgium
• Malcolm Carlisle OBE, Chairman Technical and Regulatory Policy Group, ABHI, UK

Plus other speakers invited