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

Global Transparency Requirements & Medical Meetings

Agnès Canonica, CMP, CMM

French Sunshine ActDeclaration 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

ResourceCBI 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 thatsurvives, nor the most intelligent that survives. It isthe one that is the most adaptable to change.”

- Charles Darwin

PRESENTER’S CONTACT INFO