The Advanced Legal, regulatory and Commercial guides to Medical Devices

Venue: Hilton Munich City

Location: Munich, Munich, Germany

Event Date/Time: Feb 26, 2007 End Date/Time: Feb 27, 2007
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The fast-developing and increasingly lucrative field of medical devices covers more than 10,000 types of products, and it is in continuous growth. Recent figures show the total value of the European medical technology market amounts to 55,2 bn Euro, and Europe is the second largest market after the US, with 30% of the global share. It follows that there is a pressing need to be up to date with the latest regulatory and legal developments in order to strengthen and sharpen your insight into the key issues dominating the industry.

This conference covers an array of topics aimed at offering you a detailed outlook on the matters that count. Learn more about the debate surrounding public procurement and in-house manufacturing; be up-to-date with the new environment of clinical investigations and advanced therapy regulation; hear about the health economic evaluations to take into consideration whilst defining pricing issues; and tackle the issues surrounding combination and borderline products.

Experts will also discuss how to effectively deal with commercial compliance, outlining the best practices to follow when labelling, advertising and promoting medical devices.
Don’t miss out on expanding your knowledge about what is going on in Central and Eastern Europe, which represent a total market of 309 million people and a combined GDP of US$1.9 trillion in 2006. Explore the opportunities available in these countries, and come away with in-depth knowledge of their market features, economic indicators and regulatory characteristics.
Be aware of product liability and litigation trends both in the EU and in the US, get noticed in a crowded market by creating successful partnerships, be updated on the medical device vigilance system and focus on the key elements of developing and employing an effective risk management system.

At this high-level event you will have the chance to discuss hot topics with key industry players, analyse legal issues from a business perspective and achieve a better and detailed understanding of the issues at hand. And don’t miss out on excellent networking opportunities!

Hear from high-profile experts and authoritative industry players who will offer practical and comprehensive information and insights from their own experiences on:

• Public procurement: price vs quality
• In-house assembling, technical adaptation or full manufacturing
• Advanced therapy regulation, potential regulatory gap and emerging areas of discussion
• Market features, economic indicators and key regulatory issues in CE countries
• Marketing, promoting and the EUCOMED code of practice
• Proposed changes to EN ISO 14155
• Reprocessing of a single use device and patient safety
• Techniques for resolving borderline issues
• 510 (k) format guidance
• Joint venture strategies
• Health economic evaluations for pricing and reimbursement
• Labelling and use of language & symbols
• Product liability concerns and litigation trends in the EU
• Consumer protection statues and product liability class actions
• Conducting risk analysis and effectively assessing risk
• Clinical effectiveness of joint replacement prostheses: the legal framework


Rosenheirmer Strasse