The 4th Annual TOPRA Medical Devices Symposium

Understanding Medical Device Regulatory Hurdles – Now and in the Future

TOPRA in Stockholm: Symposium Preview

This Symposium will discuss practical issues of relevance to Medical Device Manufacturers, large and small. Combination products are an increasing regulatory challenge to industry and regulators. Medical devices and drugs are regulated differently and depending on classification of a combination product the process for market access will be different. During the Symposium the following will also be covered: Borderline and Classification Issues, Implementation of Directive 2007/47/EC and What Does The Future Hold.

2009 will see TOPRA's 4th Medical Devices Symposium. Previous Symposia were held in Amsterdam, Copenhagen and Budapest. Building relationships is an important part of the TOPRA Symposium and this year we welcome the Medicines
Product Agency, Sweden, who will be assisting with the organisation of the programme. This meeting will be an ideal opportunity to get to know this important agency better, as well as to network with key regulatory professionals in the Medical Devices field.

Organised in conjunction with Medical Devices Medical Products Agency, Sweden

• Hear the latest regulatory intelligence on key issues in Regulatory Affairs from our international speaker panel.
• Collect new ideas to help you and your business meet the challenges and maximise the opportunities offered by the current regulatory environment.
• Maintain and develop your network of industry, Notified bodies and Competent authority contacts.

Confirmed Speakers include:

• Neil Adams, BSI, UK
• Gert Bos, BSI, UK
• Gert W. Bruse, MPA, Sweden
• Malcolm Carlisle, ABHI, UK
• Sébastien Hardy, LNE/G-MED, France
• Suzanne Halliday, BSI, UK
• Margareth Jorvid, LSM Group, Sweden
• Matthias Neumann, Bundesministerium für Gesundheit, Germany
• Ann O’Connor, Human Products Licensing and Registration Manager, Irish Medicines Board (IMB), Ireland
• Lennart Philipson, Scientifi c Director Medical Devices Medical Products Agency, Sweden
• Mika Reinikainen, Abnovo Ltd
• Janice Soreth, US FDA
• Valérie Viejo, KEMA, The Netherlands

Other speakers invited.

Read about last year's TOPRA Annual Medical Technologies Symposium 2008