Gmtcc 2015-Best Legal Practices

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1. Best Legal Practices Michalopoulou & Associates | 40 Ag. Konstantinou st. | Aithrio Business Center ( 16-18) | 15 124 Marousi Athens Greece T : +30 210 330 52 30 | F : +30 210 330 52 32 | info@lawgroup.gr | www.lawgroup.gr 2. It is entirely possible, under certain circumstances and in certain countries, that nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product in a foreign country will involve a foreign official within the meaning of the FCPA. Healthcare Compliance Former Assistant US Attorney General Lanny Breuer, Washington, DC, 2009 3. Cartel fines will continue to be set transparently based on the EU Commissions 2006 Fining Guidelines, but substantial penalties that will ruin any undue profits will be critical to EU cartel enforcement. Healthcare Compliance EU Competition Commissioner, Margrethe Vestager, Brussels, 2014 4. ealthcare Compliance 5. Why? ealthcare Compliance Global edTech Alliance Harmonization of Ethical Business Practices 6. Why? ealthcare Compliance Did you know that... - To U 6 1980 79 2010? - 9.5% 2010, , 4% 1960? http://www.medtecheurope.org/medtech/key-facts-figures 7. Why? ealthcare Compliance Did you know that... - H 575.000 ? - T 100 ? - 4 . R&D? - Y 25.000 EU ? - 95% MedTech SMEs, ? OECD Health Data, 2012 8. Why? ealthcare Compliance Global edTech Alliance Guidelines 9. Why? ealthcare Compliance T SALES & MARKETING ETHICS : T , US, U . , 10. Why? ealthcare Compliance-U Soft Law 11. Why? ealthcare Compliance-U Soft Law (direct sponsorship) 1/1/2018 & (indirect sponsorship) 12. Why? Healthcare Compliance-EU Soft Law Medtech? , , (continuing medical education) 13. Why? Healthcare Compliance-EU Soft Law EUCOMED (European Medical Technology Industry Association) U. : 68 (direct corporate members) 25 (national industry associations) 3 (associate Members) 4,000 (local association members) H, & 14. Why? Healthcare Compliance-EU Soft Law - Eucomed Guidelines on Interactions with Healthcare Professionals (2008) - Q&As on the Eucomed Guidelines On Interactions with Healthcare Professionals (updated regularly) - Eucomed Compliance & Competition Law Guidelines (2012) - Procedural Framework (2012) - Opinions and advisory interpretations of the Eucomed Compliance Panel (ref. Conference Vetting System) (, ). EUCOMED E (CODE COMMITTEE) 15. When? Healthcare Compliance-EU Soft Law - , , - - - / 16. When? Healthcare Compliance-EU Soft Law EUCOMED (COMPLIANCE PANEL) M ethics and compliance projects in the European MedTech industry. NEW: CVS (Conference Vetting System) . 17. When? ealthcare Compliance-U Soft Law conference vetting system (CVS); -E - UCOMED 18. When? ealthcare Compliance-U Soft Law Conference Vetting System (CVS) ; - - - SOS , spa - - , . - - H . i) ( + ) ii) ! - ; 19. When? ealthcare Compliance-U Soft Law CVS ( PCO) + + + EUCOMED, /, (COs) Medical Societies EUCOMED CVS EUCOMED 20. When? ealthcare Compliance-U Soft Law EUCOMED COMPLIANCE PANEL? O ucomed 90 ( , , ) 21. When? Healthcare Compliance-EU Soft Law EDMA (European Diagnostic Manufacturer ssociation) in-vitro diagnostic (IVD) U : 500 K EDMA : , ! 22. When? Healthcare Compliance-EU Soft Law COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry) -Health E: China Desk: W CODE OF CONDUCT ON INTERACTIONS WITH HCPs since JANUARY 2015! - min 6 : E. , ! Reporting to COCIR 23. When? Healthcare Compliance-US Soft Law ADVAMED (dvanced Medical Technology Association) E: , H 80% : 100USD : , , 24. When? Healthcare Compliance-US Soft Law (Compliance Program) : 1) 2) 3) 4) ( ) 5) 6) 7) 25. When? Healthcare Compliance-GR Soft Law ( ) Dos & Donts / / : & & , 26. : : : : (, , . , , & o ) : ) ) : : : * & ( ) : * , , , When? Healthcare Compliance-GR Soft Law 27. When? Healthcare Compliance-GR Soft Law : : : : : : : fora & ) : : ) : 28. When? Healthcare Compliance-GR Soft Law 9 : / ( , . , , , ) min 1 5 (, , , ) 4 ,, 10 2 ( ) 29. When? Healthcare Compliance-GR Soft Law : i) (60% ) ii) , , 2 (conflict of interest) 30. When? Healthcare Compliance-GR Soft Law : , , , ( ) : 250 ( )/ : 400 ( )/ SOS - : : 4 31. When? Healthcare Compliance-GR Soft Law : EY: : 3 / : , (honorarium) H . 32. When? Healthcare Compliance-GR Soft Law E-: : i) . / : 2 ii) , , , 1 33. When? Healthcare Compliance-GR Soft Law EIB ( & ) : - - - - - - 34. When? Healthcare Compliance-GR Soft Law 7 : i) ii) iii) , , , 35. How? ealthcare Compliance: The ONLY Way ForwardOUTLINE SFT LAW ; (Code of Conduct) O SINGLE BEST COMPLIANCE PROGRAM 36. The Eucomed Ethical Business Logo programme How? ealthcare Compliance: The ONLY Way Forward 37. ealthcare Compliance: The ONLY Way Forward 38. How? ealthcare Compliance: The ONLY Way Forward compliance @lawgroup.gr