Software & e-Labelling Issues for Medical Device & Biotech Companies

Date : Thursday 28.07.05

Details : BioMedIreland* invites you to attend another important event in the series covering Quality Assurance & Regulatory Affairs. This event will give Directors, Management Teams, Product Design Managers, Engineers, Process Owners, Quality Assurance and Regulatory personnel an up-to-date insight into current software and e-labelling regulations and compliance issues associated with the design and use of software in Medical Device and Biotech products.

Dr Peter Donnelly – CEO BioBusinessNI, will chair this event introducing:

Fran O’Hara – Insight Test Services
Fran has over 20 years experience, working with Philips Research Laboratories (Netherlands), Telectronics Pacing Systems (Australia) and Q-SET (Ireland). He is a regular speaker at seminars and International Conferences, a trained TickIT auditor, a qualified tutor for the ISEB software testing certificate and a trained SEI CMM lead assessor. He is ex-chairman and co-founder of the new Irish special interest group in software testing, SoftTest Ireland, and he was recently made a fellow of the Irish Computer Society. He is a co-author of the RPI method developed with Jim Hart and supported through RPI Alliance Ltd.

Caroline Freeman – Quintiles Consulting
Caroline is a regulatory affairs professional with 19 years practical experience in European and international medical device regulatory issues, including specifically the medical device directives, national directive transposition issues, labelling, clinical investigations and developing international regulations. Representing the ABHI on the Eucomed E-labelling Task Force, Caroline has attended the inaugural meeting of the European Commission’s E-labelling Working Group. With the formation of the E-labelling Working Group, the European Commission has undertaken to provide guidance on electronic labelling – the circumstances in which it is appropriate and how it can best be achieved securely.

Caroline will give an overview of the background to the industry drive for e-labelling; analyse why “general” medical devices are being treated separately from IVDs; present the current status of the e-labelling guidance and look at other initiatives around the world.

Refreshments and lunch will be served.

To register online, please click on the following link:

http://www.ibec.ie/0/imda_events

Please Note: Bookings will only be taken on-line and an invoice will be sent to you after the event.

Insight Test Services is Irelands leading consultancy on issues relating to the regulation of Software in Medical Devices.

Quintiles Consulting (formerly Medical Technology Consultants) is one of the leading regulatory consultancy firms on issues relating to the EU medical devices directives.

* BioMedIreland is an all-island network, established by IMDA, IBIA, BioBusiness NI and InterTradeIreland to facilitate & enhance the competitive positioning and innovation capabilities of the health technology and biotechnology sectors on the island of Ireland.

Location : Crowne Plaza Hotel, Dublin

Times:
09:30 for 10:00 start (16:00 finish)

Cost:
€95.00/£70.00 euro pp

Contact:
For all queries on the event, please call the event organiser:
Grainne MacAnthony, Tel: +353 1 6051593


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