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Meet your facilitators:
                 Michelle Bartolone
    Meeting Sites Pro, Inc./Global Meetings Group

                  Agnès Canonica
                    MD Events

                 Angie Duncan
              CWT Meetings & Events

                 Kimmarie Everett
                     Biolase
JEOPARDY
  U.S.    International   Medical Devices /
                            Tradeshows
 $250         $250              $250

 $500         $500              $500

 $1000       $1000             $1000

 $ 1500      $ 1500            $ 1500

 $ 2000      $ 2000            $ 2000
ROW 1
U.S.
$250


        It is the name of the federal
       law that will require tracking
           and reporting spend on
                  physicians.
What is…



       the Sunshine Act?
ROW 2
U.S.
$500


       It is a document issued by the
             OIG that outlines the
        obligations an entity agrees
               to as part of a civil
                   settlement.
What is…


             a CIA
       (Corporate Integrity
          Agreement)?
ROW 3
U.S.
$1000

        These states/district share this
          commonality: California;
          Washington, DC; Maine;
         Massachusetts; Minnesota;
             Nevada; Vermont;
                West Virginia.
What are…


     the states & district that
      currently have specific
     reporting requirements?
ROW 4
U.S.
$1500


         Drugs, Medical Devices,
           Biological, Medical
          Supplies, and Group
        Purchasing Organizations
          comprise this group.
What…


      manufacturers in Life
    Sciences will be impacted
      by the Sunshine Act?
ROW 5
U.S.
$2000


         It is the name of the
        government area that
         regulates life science
        companies’ marketing
                activities
What is…



           the FDA?
ROW 1
INT’L
 $250


        Lunch cap of € 40, dinner cap
        of € 75, hotel cap of € 250 per
            room (incl. breakfast),
             required application
              submission (€ 165).
What is…



       MDEON (Belgium)?
ROW 2
INT’L
 $500




        € 60 dinner cap (including
                beverages)
What is…



           Germany?
ROW 3
INT’L
$1000


        This HCP must arrive no earlier
          than 12 hours prior to start of
        event and depart within 12 hours
         post event AND must fly coach
           no matter the destination.
What is…



           Italy?
ROW 4
INT’L
$1500




        The Canadian code for ethics, compliance &
                      transparency.
What is…



           Rx&D?
ROW 5
INT’L
$2000
        This code mandates the following:
        Appropriate Venue: All Events must be held in an
        appropriate venue that is conducive to the scientific or
        educational objectives and the purpose of the Event or
        meeting. Companies must avoid using renowned or
        extravagant venues. The additional requirements set forth
        in Article 7 of this Code also apply accordingly.
        Refreshments and/or meals incidental to the main
        purpose of the Event can only be provided:
        exclusively to participants of the Event; and
        if they are moderate and reasonable as judged by local
        standards.
        Entertainment: No entertainment or other leisure or
        social activities should be provided or paid for by member
        companies.
What is…



           IFPMA?
ROW 1
MD/T
$250




       The EU equivalent to AdvaMed.
What is…



           EUCOMED?
ROW 2
MD/T
$500


        The commonality between
        these countries: Slovakia;
          France; Italy; Belgium;
       Denmark; Finland; Estonia &
                Lithuania
What are…

        countries that have
    recently enacted legislated
           transparency
          requirements?
ROW 3
MD/T
$1000
          This code prohibits member companies from
          paying for any entertainment or recreational
            activities or providing gifts to healthcare
          professionals, including the noneducational,
         branded promotional items typically offered as
        booth giveaways at medical trade shows, such as
             pens, notebooks, and mugs. In an FAQ
            document that accompanies this code, it
          specifies the companies may not raffle items
             during a trade show that are otherwise
        prohibited under the code (for example, airline
                              tickets).
What is…



           AdvaMed?
ROW 4
MD/T
$1500


        CMEs can be offered as part of
            tradeshows, as they are
               independent and
        manufacturers have no control
        or input into the content, the
         speakers, or the attendees.
What is…


     not covered as part of the
          Sunshine Act?
ROW 5
MD/T
$2000

           Pharma company X has
          published a brochure for
        patients to understand what
         the laser technology can do
         and will hand it out to their
        customers at the booth at no
                    charge.
What is…


     exempt to being reported
         in HCP TOV?

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Global regulatory jeopardy

  • 1.
  • 2. Meet your facilitators: Michelle Bartolone Meeting Sites Pro, Inc./Global Meetings Group Agnès Canonica MD Events Angie Duncan CWT Meetings & Events Kimmarie Everett Biolase
  • 3. JEOPARDY U.S. International Medical Devices / Tradeshows $250 $250 $250 $500 $500 $500 $1000 $1000 $1000 $ 1500 $ 1500 $ 1500 $ 2000 $ 2000 $ 2000
  • 5. U.S. $250 It is the name of the federal law that will require tracking and reporting spend on physicians.
  • 6. What is… the Sunshine Act?
  • 8. U.S. $500 It is a document issued by the OIG that outlines the obligations an entity agrees to as part of a civil settlement.
  • 9. What is… a CIA (Corporate Integrity Agreement)?
  • 10. ROW 3
  • 11. U.S. $1000 These states/district share this commonality: California; Washington, DC; Maine; Massachusetts; Minnesota; Nevada; Vermont; West Virginia.
  • 12. What are… the states & district that currently have specific reporting requirements?
  • 13. ROW 4
  • 14. U.S. $1500 Drugs, Medical Devices, Biological, Medical Supplies, and Group Purchasing Organizations comprise this group.
  • 15. What… manufacturers in Life Sciences will be impacted by the Sunshine Act?
  • 16. ROW 5
  • 17. U.S. $2000 It is the name of the government area that regulates life science companies’ marketing activities
  • 18. What is… the FDA?
  • 19. ROW 1
  • 20. INT’L $250 Lunch cap of € 40, dinner cap of € 75, hotel cap of € 250 per room (incl. breakfast), required application submission (€ 165).
  • 21. What is… MDEON (Belgium)?
  • 22. ROW 2
  • 23. INT’L $500 € 60 dinner cap (including beverages)
  • 24. What is… Germany?
  • 25. ROW 3
  • 26. INT’L $1000 This HCP must arrive no earlier than 12 hours prior to start of event and depart within 12 hours post event AND must fly coach no matter the destination.
  • 27. What is… Italy?
  • 28. ROW 4
  • 29. INT’L $1500 The Canadian code for ethics, compliance & transparency.
  • 30. What is… Rx&D?
  • 31. ROW 5
  • 32. INT’L $2000 This code mandates the following: Appropriate Venue: All Events must be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the Event or meeting. Companies must avoid using renowned or extravagant venues. The additional requirements set forth in Article 7 of this Code also apply accordingly. Refreshments and/or meals incidental to the main purpose of the Event can only be provided: exclusively to participants of the Event; and if they are moderate and reasonable as judged by local standards. Entertainment: No entertainment or other leisure or social activities should be provided or paid for by member companies.
  • 33. What is… IFPMA?
  • 34. ROW 1
  • 35. MD/T $250 The EU equivalent to AdvaMed.
  • 36. What is… EUCOMED?
  • 37. ROW 2
  • 38. MD/T $500 The commonality between these countries: Slovakia; France; Italy; Belgium; Denmark; Finland; Estonia & Lithuania
  • 39. What are… countries that have recently enacted legislated transparency requirements?
  • 40. ROW 3
  • 41. MD/T $1000 This code prohibits member companies from paying for any entertainment or recreational activities or providing gifts to healthcare professionals, including the noneducational, branded promotional items typically offered as booth giveaways at medical trade shows, such as pens, notebooks, and mugs. In an FAQ document that accompanies this code, it specifies the companies may not raffle items during a trade show that are otherwise prohibited under the code (for example, airline tickets).
  • 42. What is… AdvaMed?
  • 43. ROW 4
  • 44. MD/T $1500 CMEs can be offered as part of tradeshows, as they are independent and manufacturers have no control or input into the content, the speakers, or the attendees.
  • 45. What is… not covered as part of the Sunshine Act?
  • 46. ROW 5
  • 47. MD/T $2000 Pharma company X has published a brochure for patients to understand what the laser technology can do and will hand it out to their customers at the booth at no charge.
  • 48. What is… exempt to being reported in HCP TOV?