Agenda

1. Irish Medical Technology Industry Compliance Training Workshop(Jointly run by Eucomed/ IMDA/ IMSTA/ Life Science Skillnet)26 January 2011 – Cartlon Hotel Dublin Airport

2. 9.00 – 9.15Welcome & introduction Barry McBride, Teleflex (IMDA Baord Member & Taskforce Chair) 9.20 – 10.30Workshop: The principles of the Eucomed Guidelines on the Interaction with Healthcare Professionals and their interpretation and application • Karen Leyshon, Convatec & Aline Lautenberg, Eucomed • 10.30 – 10.50Coffee break 10.50 – 13.00Business decision-making game: Paving the way to ethical congresses Marc Merckx, Business Integrity Solutions (ISMS) 13.00 – 13.45Lunch 13.45 – 17.00 Case-studies (including coffee break) Donations and grantsKaren Leyshon, Convatec Transparency and notificationsAlphie Moran, Cook Medical Third-party management and sponsorships, Aline Lautenberg, Eucomed 16.45 – 17.00Final discussions and close of the workshop Agenda

3. Welcome and OverviewCode of EthicsBarry McBride

4. Relationships required for innovation in medical technology industry changing • The long collaborative tradition between the medical technology industry and the healthcare profession has produced groundbreaking treatments, which have transformed healthcare in general, and patient quality of life more specifically. • The relation between the industry and its customers, the healthcare professionals (HCPs), is changing. The situation is overborne by some criminal legislation or by the threat that, if industry or HCPs/customers do not behave appropriately, legislation will be imposed. In order to guarantee the reputation of the industry. • The medical technology industry is truly committed to ensuring that this vital cooperation adheres to the highest ethical standards.

5. Scope of the Eucomed Code • The Code covers Eucomed members and their relationships with Health Care Practitioners (HCPs_. • HCPs are defined as individuals or entities that directly or indirectly purchase, lease, recommend, use, purchase, or prescribe medical devices. • Third-party intermediaries include both sales intermediaries and other agents who interact with HCPs during the sale, promotion or any other product-related activity.

6. Industry and Suppliers Partnership ….

7. Steering Group Chair Barry McBride Telefex/ IMDA Board Member • Jonathan Collard Covidien • Emmett Devereux Cook Ireland • Phil Watson Cappella • Karl Goulding Oxygen Care (Chair IMSTA) • Austin O'Connell Stryker • David Carthy William Fry Solicitors • Justin Carty IMSTA • Sharon Higgins IMDA

8. Process - proposal

9. Panel Members • Chair: Berchmans Gannon Retired Solicitor who specialised in the area of Healthcare, Medical Malpractice and Medical Risk Management. Since retirement, he had worked on a consultancy basis with the HSE, voluntary hospitals and other healthcare service providers in the areas of Healthcare Risk Management and Dispute Resolution (Mediation & Arbitration). He is a sitting member of the Solicitors Disciplinary Tribunal. • Liam Downey is the former Chairperson of the Health Service Executive. He was Chief Executive Ireland of Becton Dickinson, a leading global medical technology company. He was also President of the Federation of Irish Employers, a trustee and member of the board of the Irish Business and Employers Confederation (IBEC), Chairman of the Irish Medical Devices Association and a member of the Labour Relations Commission. He is currently a non-executive board member of VHI Healthcare. He is a graduate of University College Dublin, a chartered member of the Institute of Personnel Development and a Fellow of the Irish Management Institute. • Siobhan O'Daly t: 01 6685001 M: 087 687 4903 sodaly@Irishheart.ieconfirmed Research Development Manager, Irish Heart Foundation (interim). Siobhan joined the Irish Heart Foundation in February 2010. Siobhan is responsible for the development and management of the National Cardiovascular and Stroke Research Network. This position; funded by the Irish Heart Foundation, was created in response to the need for a centralised research network in cardiovascular disease and stroke. Siobhan has worked for a number of pharmaceutical companies over the last 12 years where she was responsible for the implementation and management of clinical trials covering a wide range of therapeutic areas • W. P. (Bill) Blunnie, M.B. B.Ch. B.A.O. F.F.A.R.C.S.I. Retired Consultant in Anaesthesia & Intensive Care. Previously Dean of Faculty of Anaesthesia RCSI. Hon. Sec. European Board of Anaesthesiology, Council Member Association of Anaesthetists of GB & Ireland, Member Standards Committee in Ireland AAGBI and Council Member Faculty of Anaesthetists RCSI.

10. Example

11. And so to the programme ……

12. 9.00 – 9.15Welcome & introduction Barry McBride, Teleflex (IMDA Baord Member & Taskforce Chair) 9.20 – 10.30Workshop: The principles of the Eucomed Guidelines on the Interaction with Healthcare Professionals and their interpretation and application • Karen Leyshon, Convatec & Aline Lautenberg, Eucomed • 10.30 – 10.50Coffee break 10.50 – 13.00Business decision-making game: Paving the way to ethical congresses Marc Merckx, Business Integrity Solutions (ISMS) 13.00 – 13.45Lunch 13.45 – 17.00 Case-studies (including coffee break) Donations and grantsKaren Leyshon, Convatec Transparency and notificationsAlphie Moran, Cook Medical Third-party management and sponsorships, Aline Lautenberg, Eucomed 16.45 – 17.00Final discussions and close of the workshop Agenda