1. Pharma Compliance The way forward 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. Why Transparency? R&D gives room to Creativity. Transparency is Cheaper! Richard Bergstrom, EFPIA General Director Pharma Law Convention Bucharest 2014 Pharma Compliance: The ONLY Way Forward

3. Pharma Compliance: The ONLY Way Forward Confidential Information & Intellectual Property Rights DATA PROTECTION ANTI-CORRUPTION Patient Safety Competition & Antitrust SALES & MARKETING ETHICS

4. Compliance Jargon ...

5. Anti-Bribery Laws Globally B : FCPA ( ) /OECD ( )

6. FCPA

7. FCPA ( 1977 2002) (Foreign Corrupt Practices Act) / , , . , , .

8. FCPA : SEC , (Securities Exchange Act) 1934 FCPA , , , . : FCPA - FCPA; , , , ! : , FCPA , , , .

9. : FCPA

10.

11. 17 1997. 35 FCPA. . 15 , 1999. . OECD

12. . .

13. 2656/98 (. 3090/2002) 2 , , , , , , , 1 , , , 1 . 3 : . . , , 3 ,

14. 4 (....). 5 , , , , ....: ) 3 ) ) SOS

15. 3691/2008 ( 2005/60/ & ) , 7: 3: ) ( 235) 1 , 50 150.000 . , 10.000 150.000 . ) ( 236) , , , , , , 50 150.000 . , 10.000 150.000 .

16. (. 2005) 6 . 4 , . . 36 . 6 . 4 . ) ) 2 ) 50.000 200.000 .

17. Protection of Personal Data

18. Protection of Personal Data U DATA PROTECTION REFORM Data Protection is made in Europe. Strong Data Protection rules must be Europes Trademark. Viviane Redding, Vice-President & Justice EU Commissioner EU Parliament Strasbourg, March 2014

19. Why Reform? A (easier access to your own data, putting you in control, data protection first not an afterthought) (one continent-one law, one- stop- shop) Protection of Personal Data

20. Current EU & GR Legal Framework: Impossible to contract out . 2472/1997 (EU 95/46/C Data Protection Directive & U e-Privacy Directive 2002/58/EC ) 2 ) : (, , , , , , , , ) . , . ) : , , , , , , , . ) : (, , , , ).

21. Current EU & GR Legal Framework: Impossible to contract out 3 , . 2 ) : , , , , , , , , , , , , (), , .

22. Current EU & GR Legal Framework: Impossible to contract out 4 SOS 3. , : ) ) - , , , , . U Directive 95/46: 19: ) , ) -, .

23. Current EU & GR Legal Framework: Impossible to contract out 2 ) : , , . 7 & 7 SOS 1. . 2. , : ) (, ).

24. Current EU & GR Legal Framework: Impossible to contract out ) ( ) , , & . , , , . ) o . 3. .

25. Current EU & GR Legal Framework: Impossible to contract out 9 1. : ) ) . 10 1. . .

26. Current EU & GR Legal Framework: Impossible to contract out 11 SOS : ) ) ) ) 12 . 13 . (, , ) 15 .

27. European Federation of Pharmaceutical Industries & Associations

28. EFPIA -List of Guiding Principles Promoting Good Governance in the Pharma sector Code on the Promotion of Prescription-only Medicines to & Interactions with Healthcare Professionals (HCP Code) Code of Practice on Relationships between the Pharma Industry & Patient Organizations (PO Code) EFPIA 24/6/2016 - 2015! EFPIA

29. -Compliance A-Z

30. ( 4/4/2014 14/4/2014) () (): No (, TV, , internet)! = . . NEW / , / . Dos & Donts

31. : , e-mails . SOS / . (data on file) . .. , . : . , . ff-label . Dos & Donts

32. : W W : 2 max I : . Dos & Donts

33. Dos & Donts & ( 1/1/2014): , . ) 15 / (apps) / medical devices (. ..) ( CD/DVD/ USB) X ( ) , ) : 100 ! 100 NEW ) .

34. Dos & Donts / / : & & : ) , ) , , ) ) & & NEW : ) ( - ) ) ( : , , , ) . & ( 31/3 site )

35. : : : : (, , . , , & ..) : ) ) : 3 / 2 2.500 10.000 (. ) 1 & 2 & site . : PCO : : : & ( ) : Dos & Donts

36. Dos & Donts : : : : : : & . : : fora & ) : : : ) : : 10 /

37. Dos & Donts : , , , , . : . onorarium: - Declaration of Interest 2 & - 5.000 ( ) / : : 140 (. ) : 250 ( ) : : 70 (. ) : 70 ( )

38. Dos & Donts : : 5 (US & Canada): 10 (U): 30 EY: : 3/ : 5 / : ,

39. Dos & Donts Internet-Digital Applications SOS : & & & . & . & . (disclaimer) SOS. To , & .

40. Dos & Donts Internet-Digital Applications Websites a) WebSite , , , b) Website a&b: & : c) Website I & : & / .

41. Dos & Donts Internet-Digital Applications d) Websites EY: site : username & password 8 SPC site . SOS & & & copyrights site Cookies , &

42. Dos & Donts Internet-Digital Applications (eDetailing) EY Web, CD, Video, ablets, Smartphones SOS & & & copyrights site Cookies , & 15 . SOS &

43. Dos & Donts Newsletters/Emailing : & emails (opt-out) email & Facebook & Twitter Logo (, , Marketing, Compliance, , -business, E) & . : (& ) , & 24 7/7 Facebook & Twitter: ( ) ( 6 )

44. Compliance developers app ; (app stores) Case-by-case enquiries, non-compliant!

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46. 1. . , . O . ; ;

47. 2. . . ; ;

48. 3. . , . ; ;

49. 4. dossier . . dossiers. Compliance ;

50. 5. T ( U / ) phone app (EU & Non EU) / , / , , , , , / , , : ) ) . phone identifier server . ;

51. 6. app . . . X ; ; ;

52. ...

53. The future is bright. Pharma Compliance: The ONLY Way Forward compliance@lawgroup.gr Everything changes.