IMDA Quality Conference 2012

Irish Medical Device Association Conference 2012



Programme

Overview

This year’s event will host over 15 key international speakers, including senior representatives from; the European Commission, the Irish Medicines Board (IMB), US Food and Drug Administration (FDA), Eucomed, EDMA, corporate QA/RA Directors and VPs. The conference will cover recent developments, trends and case studies related to quality regulations worldwide including perspectives from across Europe, USA, India, China, Russia and the Middle East.

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The first session will compose of a keynote industry address followed by a presentation from Ms. Jacqueline Minor, Director of Consumer Affairs at the European Commission, a central figure in the development of proposals relating to the revision of the European regulatory framework. Delegates will be presented with a timely update on developments within the European Commission relating to the imminent revision of the MDD, AIMD and IVD Directives in Europe. The presentation will provide the EU Commission’s rationale behind the revision and expected next steps for Europe.

Session one continues with a presentation outlining the priorities of the Irish Competent Authority (IMB) and a summary of the key legislation that impacts the industry both on a National and European level, as well as perspectives on the revision proposals by the IMB, Notified Bodies Group (NB-MED) and from an industry perspective (Eucomed).

In session two, delegates will learn about the current compliance and enforcement trends at FDA, as well as an update on the proposed changes to the 510(k) program, from a regulator’s, as well as an industry perspective.

The third session will review the regulatory and practical challenges of accessing unique markets such as India, China, Russia and the Middle East, with presentations delivered by senior industry representatives from these important emerging markets. Thus concluding the formal component of day one of the conference.

The Conference Dinner will take place later that evening and provides an important opportunity for networking among peers from Ireland and senior counterparts from across the globe. We are delighted to have Nessa Childers, MEP and member of the European Parliament’s Environment, Public Health and Food Safety Committee, among others, as our guest of honour.

Day two of the conference, and session four, will commence with presentations outlining important developments for manufactures relating to Unique Device Identification (UDI), and a second presentation outlining A-labelling (alternative labelling) and implications for European manufacturers. The session will conclude with a detailed exploration of proposed revision of IVD Directive being reviewed by EDMA.

Session five will conclude this extensive conference, with an industry perspective on FDA auditing trends, a lively presentation on complaints compliance, and finishing with a review of the changing clinical evidence requirements for medical devices.

In this section:

Sponsors:

NSAI
Boston Scientific
Medtronic
Abbott Ireland
Compliance and Risks
Cook Medical
Greenleaf Health LLC
Life Sciences Skillnet
Nvolve

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