PIPA - Pharmaocovigilance for Medical Devices & Drug-Device Combinations

Date: 5 May 2010
Venue: Chandos House, 2 Queen Anne Street, London

Please note: As a non-profit making organisation, PIPA only trades internally amongst the PIPA membership and does not trade with, or accept sponsorship from, external organisations without PIPA representation. If you wish to attend this event and are not currently a member of PIPA, you will first need to join PIPA. Membership of PIPA costs £60 per annum. Please contact administrator@pipaonline.org for further details and to reserve your place on this event.

10.30am - 3pm, lunch included

There will be no charge for attendance for a delegate volunteering to write a report on this forum for PIPELINE. (Limited to one delegate per forum.)

This half-day discussion forum will be introduced and led by Brian James, Interface International Consultancy Ltd.

Topics to be discussed include, but are not limited to:

Current UK/EU legislation;
Pre-marketing requirements including technical file development, risk analysis including standard 14971, CE marking;
Post-marketing requirements including marketplace feedback, continuing product risk management and safety, formal government safety reporting requirements;
Directive 2007/47/EC - are you complying?

The forum will give those interested in medical devices and drug-device combinations an overview of where ADR reports fit into the regulatory process, the way this links into technical files and also how to deal with both the Competent Authorities and Notified Bodies in Europe. Examples of case histories will be discussed during the day. The forum will be highly participative and if there are any specific concerns that you would like to discuss during the forum, then please send details of these to Anne Turnbull (see below) at least one week prior to the event.

For further information, please contact Anne Turnbull, PIPA Operations Support, via operationssupport@pipaonline.org.

Member Price (inc. VAT): £76.38

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