Tuesday, September 14, 2010

Medical Device Approvals in the European Union: Significant Changes Now in Effect

Getting your devices approved in the EU has just become a bit more complicated. The transitional period is over and changes to the Medical Device Directive have now, in principle, been implemented by the 27 EU Member States. Device manufacturers, notified bodies and national authorities must now respect the new rules.

As of March 21, 2010, the new legislation governing, among other things, clinical data and the classification of software as a medical device, has entered into force. Are you in compliance and ready for an audit by an EU inspector?

In 90 minutes, Elisabethann Wright, Partner at a Brussels-based partner with the international law firm Hogan & Hartson will discuss the most important changes, their implications and how to comply with these new requirements.

During this webinar, you will learn:

How software can now be considered a stand-alone medical device
The implications of the new provisions for existing certificates of conformity
The consequences for clinical data requirements
How the new legislation affects different classes of medical devices

Elisabethann Wright will also answer your team's questions in the Q&A session.

Who should attend...

Auditors
QA/QC managers
Compliance officers
Executive management
Regulatory affairs professionals
General and corporate counsel

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q&A.

SPEAKER

Elisabethann Wright
Partner
Hogan & Hartson

Elisabethann Wright's experience in the area of European law has included both private practice and periods working with international institutions. She focuses on European Union law relating to life sciences, with particular emphasis on pharmaceutical law, medical devices, food law, and the environment. This includes assisting clients in classification of their products, establishment of a pathway to authorization and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals and challenges to national authority and EU Institution decisions concerning classification and marketing of medicinal products and medical devices.

Elisabethann has extensive experience in litigation before the European Court of Justice, the European Court of First Instance, and the European Free Trade Agreement (EFTA) Court. Her practice includes advising on the challenge ability of decisions of EU Institutions and the validity of EU legislation.

Webinar Details

DATE: Tuesday, September 14, 2010
TIME: 11:00 AM ET • 9:00 AM MT • 8:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

Convenience—and lower cost. Your entire team can listen in one room. No travel required!
A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

$349 - Recorded Webinar with Complete Transcript, click here
Register by email: custcare@elsevier.com
Register by phone: +1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.