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Case-studies

Case-studies. Irish Medical Technology Industry Compliance Training Workshop January 26, 2011, Dublin Karen Leyshon , Convatec ;; Alphie Moran, Cook & Aline Lautenberg, Eucomed. Organisation: Instructions. Please sit at your respective tables.

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Case-studies

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  1. Case-studies Irish Medical Technology Industry Compliance Training Workshop January 26, 2011, Dublin Karen Leyshon, Convatec;; Alphie Moran, Cook & Aline Lautenberg, Eucomed

  2. Organisation: Instructions • Please sit at your respective tables. • Each group will have around 30 minutes to discuss one case. • If nothing is provided, feel free to discuss different assumptions. • A discussion will follow with the entire group based on the feedback from one of the tables (by the leader of the table). • Same process of the two other cases.

  3. Case-study 1 Donations & grants • You are the MD of the company “Imagine” and you are visiting a Paediatric Oncologist KOL at a prominent medical school. The professor is a recognized authority in the country and also an advisor to the MoH on reimbursement matters. • The professor’s husband is a successful businessman and is active in a major charity that seeks to improve patient education to help with the detection and treatments in Paediatric Cancer. • During your visit, the professor explains that she is seeking funding for an exciting new research initiative involving your company’s products where she will be the Principal Investigator. She urges you to consider supporting her research efforts. • As the visit comes to a close, the professor mentions that her husband heads up a charity that is entering a new fundraising cycle; she expresses her hope that your company will be able to continue its very generous support for the work of the charity again this year. • On your way home, you are briefed on the status of the government’s upcoming reimbursement decision that will have important implications to your company’s product as well as three competitive products. The professor is expected to participate in advising the government on its decision.

  4. Case-study 1 Donations & grants • Questions • In the situation described, do you feel that the requested donation and grant are compliant under the Eucomed Guidelines? • What elements do you have to consider as a compliance officer of the company? • Please provide a follow-up discussion with the professor about the existing issues.

  5. Case-study 2:Transparency and Notification The 10th International Symposium on Paediatric Cancer will be held next November in Buenos Aires. Attendees are expected to come from different parts of the world, e.g. USA, Europe, Latin America, ASPAC. Some participants are self-employed private-practitioners, some are privately employed clinic physicians working for private clinics and some are working for public hospitals and state university hospitals. A medical device manufacturer with HQ in Germany intends to invite physicians from all three categories and reimburse their travel and accommodation costs as well as their registration fees. The invited physicians are from Belgium, France, Germany, Italy, Norway and Sweden.

  6. Case-study 2: Transparency and Notification Questions: Which transparency requirements must be met? What are the minimum requirements under Eucomed? What are the requirements that must be met when the physicians are only invited to visit the company’s exhibition stand? What if the company is only considering sponsoring a booth?

  7. Case-study 3: Third-party conferences and sponsorships • 20th Paediatric Cancer Swiss 3-day Congress held in Davos (Switzerland) • CME accredited • The congress program includes one day hands-on live training on a innovative surgical technique • The hospital chosen for that live training is a high-tech equipped hospital of Davos, which is the cantonal university hospital and considered as one of the best hospitals in Switzerland. • Training fee: € 950/participant, excluding travel and lodging (and in addition to the congress fee) • Your company agrees to sponsor: • One (1) faculty member through a grant to the organiser and • Six (6) Swiss physicians to attend the congress and the live training • In the course of the planning, the congress organiser decides to change the national congress to a European congress, invites also a number of European physicians to join (as delegates).

  8. Case-study 3: Third-party conferences and sponsorships • Questions • What can your company pay for? • What elements should you consider as the compliance officer of the company? • What if two days in a row, the program looks as follows:

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