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Global Transparency Requirements
       & Medical Meetings
     Agnès Canonica, CMP, CMM
French Sunshine Act
Declaration Scheme Willing to Be “Broader and More Transparent" than
US Sunshine Act
• The disclosure obligation, as stated in the Law, includes any
  agreements or advantages in kind or in cash, direct or
  indirect. Therefore, companies would have to disclose the following:
• “Hospitality conventions”, i.e., invitations of individual HCPs to
  scientific or medical events for which companies pay the related costs
  (such as registration fees, travel costs, meals and accommodation
  expenses)
• Agreements of any nature, including research and development
  contracts (clinical trials, observational studies), other consultancy
  agreements (speaker, advisory boards), and aids or grants in any form
• Any benefit in cash or in kind, including any gift offered to a covered
  recipient and any lunch offered to HCPs by a medical sales
  representative after a medical visit
French Sunshine Act

Still in process of government approval

http://www.jdsupra.com/legalnews/french-
sunshine-act-implementing-decree-39226/
Australia
• Equivalent of NPI # = IHI
• 16 digits
• Individual Healthcare Identifier
Country Approvals
•   CNOM – France
•   MDEON – Belgium
•   Italy
•   Spain
•   Marketing/meeting materials
Discussion
• Working through CROs
• Establishing Fair Market Value – globally
• Vendors – how can they help?
• Policies / vendor training
• How are agencies managing the influx of data
  management
• PM training
Registration
• Disclaimers
• Required fields
• Unique identifiers
TOV Reporting
•   Domestic vs. International
•   Fields
•   Licensed vs. non-licensed
•   Reporting deadlines
•   Individual vs. aggregate/average costs
•   Tracking breaks
•   DDR in EU
•   Pre/post expenses
RFID
Barcode Scanners
Sign-In Sheets
Global Clinical Payment Technology


              ClinCard
            eClinicalGPS

         www.greenphire.com
Resource
            CBI 3rd Global Transparency Reporting Congress
                 April 10-11, 2013 * Brussels, Belgium

Through this interactive forum, you will:
• Examine current international transparency regulations including an
   update on the EFPIA code
• Learn solutions for implementing a global system
• Improve business processes through communication of value
• Hear valuable case studies on managing regional requirements
• Discuss privacy and data protection implications of reporting
• Work effectively with CROs, CSOs, meeting planning agencies and
   other third parties
• Understand the impact of transparency initiatives on the relationships
   between industry and HCPs
Guiding Principal…


        “It is not the strongest of the species that
       survives, nor the most intelligent that survives. It is
       the one that is the most adaptable to change.”

                                               - Charles Darwin
PRESENTER’S CONTACT INFO

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E5 canonica, agnes global transparency requirements and medical meetings 21 mar13

  • 1. Global Transparency Requirements & Medical Meetings Agnès Canonica, CMP, CMM
  • 2. French Sunshine Act Declaration Scheme Willing to Be “Broader and More Transparent" than US Sunshine Act • The disclosure obligation, as stated in the Law, includes any agreements or advantages in kind or in cash, direct or indirect. Therefore, companies would have to disclose the following: • “Hospitality conventions”, i.e., invitations of individual HCPs to scientific or medical events for which companies pay the related costs (such as registration fees, travel costs, meals and accommodation expenses) • Agreements of any nature, including research and development contracts (clinical trials, observational studies), other consultancy agreements (speaker, advisory boards), and aids or grants in any form • Any benefit in cash or in kind, including any gift offered to a covered recipient and any lunch offered to HCPs by a medical sales representative after a medical visit
  • 3. French Sunshine Act Still in process of government approval http://www.jdsupra.com/legalnews/french- sunshine-act-implementing-decree-39226/
  • 4. Australia • Equivalent of NPI # = IHI • 16 digits • Individual Healthcare Identifier
  • 5. Country Approvals • CNOM – France • MDEON – Belgium • Italy • Spain • Marketing/meeting materials
  • 6. Discussion • Working through CROs • Establishing Fair Market Value – globally • Vendors – how can they help? • Policies / vendor training • How are agencies managing the influx of data management • PM training
  • 7. Registration • Disclaimers • Required fields • Unique identifiers
  • 8. TOV Reporting • Domestic vs. International • Fields • Licensed vs. non-licensed • Reporting deadlines • Individual vs. aggregate/average costs • Tracking breaks • DDR in EU • Pre/post expenses
  • 9.
  • 10. RFID
  • 13. Global Clinical Payment Technology ClinCard eClinicalGPS www.greenphire.com
  • 14. Resource CBI 3rd Global Transparency Reporting Congress April 10-11, 2013 * Brussels, Belgium Through this interactive forum, you will: • Examine current international transparency regulations including an update on the EFPIA code • Learn solutions for implementing a global system • Improve business processes through communication of value • Hear valuable case studies on managing regional requirements • Discuss privacy and data protection implications of reporting • Work effectively with CROs, CSOs, meeting planning agencies and other third parties • Understand the impact of transparency initiatives on the relationships between industry and HCPs
  • 15. Guiding Principal… “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is the most adaptable to change.” - Charles Darwin