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I’ll Take Global Regulatory for $/£/€/¥ 500 Please

Global regulatory jeopardy

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  • 1. Meet your facilitators: Michelle BartoloneMeeting Sites Pro, Inc./Global Meetings GroupAgns CanonicaMD Events Angie DuncanCWT Meetings & Events Kimmarie Everett Biolase

2. JEOPARDYU.S.International Medical Devices /Tradeshows $250 $250$250 $500 $500$500 $1000 $1000 $1000 $ 1500$ 1500$ 1500 $ 2000$ 2000$ 2000 3. ROW 1 4. U.S.$250It is the name of the federal law that will require tracking and reporting spend onphysicians. 5. What is the Sunshine Act? 6. ROW 2 7. U.S.$500 It is a document issued by the OIG that outlines theobligations an entity agrees to as part of a civil settlement. 8. What is a CIA (Corporate IntegrityAgreement)? 9. ROW 3 10. U.S.$1000These states/district share thiscommonality: California;Washington, DC; Maine; Massachusetts; Minnesota; Nevada; Vermont;West Virginia. 11. What are the states & district thatcurrently have specific reporting requirements? 12. ROW 4 13. U.S.$1500 Drugs, Medical Devices, Biological, MedicalSupplies, and GroupPurchasing Organizationscomprise this group. 14. Whatmanufacturers in LifeSciences will be impactedby the Sunshine Act? 15. ROW 5 16. U.S.$2000 It is the name of thegovernment area that regulates life sciencecompanies marketingactivities 17. What is the FDA? 18. ROW 1 19. INTL $250Lunch cap of 40, dinner capof 75, hotel cap of 250 perroom (incl. breakfast), required applicationsubmission ( 165). 20. What is MDEON (Belgium)? 21. ROW 2 22. INTL $500 60 dinner cap (includingbeverages) 23. What is Germany? 24. ROW 3 25. INTL$1000This HCP must arrive no earlierthan 12 hours prior to start ofevent and depart within 12 hours post event AND must fly coach no matter the destination. 26. What is Italy? 27. ROW 4 28. INTL$1500The Canadian code for ethics, compliance &transparency. 29. What is Rx&D? 30. ROW 5 31. INTL$2000This code mandates the following:Appropriate Venue: All Events must be held in anappropriate venue that is conducive to the scientific oreducational objectives and the purpose of the Event ormeeting. Companies must avoid using renowned orextravagant venues. The additional requirements set forthin Article 7 of this Code also apply accordingly.Refreshments and/or meals incidental to the mainpurpose of the Event can only be provided:exclusively to participants of the Event; andif they are moderate and reasonable as judged by localstandards.Entertainment: No entertainment or other leisure orsocial activities should be provided or paid for by membercompanies. 32. What is IFPMA? 33. ROW 1 34. MD/T$250 The EU equivalent to AdvaMed. 35. What is EUCOMED? 36. ROW 2 37. MD/T$500The commonality betweenthese countries: Slovakia;France; Italy; Belgium; Denmark; Finland; Estonia &Lithuania 38. What arecountries that haverecently enacted legislated transparencyrequirements? 39. ROW 3 40. MD/T$1000This code prohibits member companies frompaying for any entertainment or recreationalactivities or providing gifts to healthcareprofessionals, including the noneducational, branded promotional items typically offered asbooth giveaways at medical trade shows, such as pens, notebooks, and mugs. In an FAQdocument that accompanies this code, itspecifies the companies may not raffle items during a trade show that are otherwiseprohibited under the code (for example, airlinetickets). 41. What is AdvaMed? 42. ROW 4 43. MD/T$1500CMEs can be offered as part oftradeshows, as they are independent andmanufacturers have no controlor input into the content, the speakers, or the attendees. 44. What is not covered as part of theSunshine Act? 45. ROW 5 46. MD/T$2000 Pharma company X haspublished a brochure forpatients to understand what the laser technology can do and will hand it out to theircustomers at the booth at nocharge. 47. What is exempt to being reported in HCP TOV?