EMA policy on the handling of competing interests of scientific committees’ members and experts

Conflicts of interests, transparency, transparence des liens d'intérêts, sunshine act, loi bertrand

EU legislation clearly states that the members of the scientific committees and experts shall not have financial or other interests in the pharmaceutical industry that could affect their impartiality. They shall make an annual declaration of their financial interests. In addition, all indirect interests which could relate to the pharmaceutical industry shall be entered in a register held by the European Medicines Agency (referred to in this document as “Agency”), which is accessible to the public, on request, at the Agency’s offices. The Agency’s Code of Conduct provides general guidance on several aspects related to declarations of interests. Information is …

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Webinar: Making the EFPIA physician spend numbers talk!

October 27th, 2016 at 11 am CST The first public disclosure under the EFPIA transparency directive was made on 30th June, 2016, while the first data set was received in June of 2015. During this time, the press had questioned the rates of consent received from physicians in reporting spend details, but they failed to acknowledge the timely delivery of most reports and a voluntary step to disclose the spend by EFPIA members. Join us as qordata’s Practice Leader Life Science, Ned Mumtaz, presents a detailed review of the EFPIA transparency directive, physician spend numbers and delves into information pertaining to …

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Transparency in Europe: 2016 and Beyond

In June 2013, the EFPIA (European Federation of Pharmaceutical Industries and Associations) Statutory General Assembly adopted the “EFPIA code”, a code set by industry self-regulation, requiring its 33 national member associations to publicly report the transfers of value (ToV) made by pharmaceutical companies to physicians (HCPs), and healthcare organizations (HCOs). The underlying objective was to increase transparency around interactions between industry and HCPs and HCOs, to proactively address potential concerns in society around these interactions. Three years later, on June 30, 2016, the deadline set for the implementation passed. For the first time, member companies published their ToVs, disclosing their …

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Polaris : Important Compliance and Transparency Updates

Andy Bender, Founder and President, Polaris Polaris is pleased to provide a quarterly update of compliance and transparency developments and changes that took place in Q2 that may effect your business: AMERICAS TRANSPARENCY GLOBAL TRANSPARENCY PRE-NOTIFICATION OUS ABAC/FCPA PRIVACY/DATA PROTECTION US REGULATORY, ANTI-KICKBACK, FALSE CLAIMS AND CIAs FAIR MARKET VALUE

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Webinar today 12/07 19h | EFPIA Disclosure: Rights and requirements for Consent Management

Sunshine Act

  With regard to the EFPIA disclosure, privacy laws in some countries require consent given by the HCP for individual disclosure. This educational webinar will provide an overview of transparency, compliance, and anti-corruption requirements in the European Union. Example topics covered by the experts in this webinar include: Differences between EFPIA Industry Disclosure Code and Transparency Law Country specific considerations e.g In Denmark reporting obligations are on the HCP. Requirements of HCP Consent and overlap with privacy laws Anti-corruption laws and practical considerations Best practices in Physician Consent Management Date: 12th July 2016 Time: 12 PM (EST) – 6 PM (UTC+1 London) – 19h (UTC+2 …

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EFPIA Transparency Report 2016: Insights on the First Complete Cycle

The final deadline for publication and submission of reports of transparency disclosures required by the European Federation of Pharmaceutical Industry Associations (EFPIA) arrived on June 30, 2016. Companies have now completed publication of all 2015 ‘transfers of value’ (ToV) to healthcare professionals (HCPs) within the 31 countries that signed on to this initiative. Several changes to the requirements have already been made, and questions and concerns remain for amendments likely to be implemented later this year. Additional changes to the requirements are anticipated later this year. Several countries have lobbied to have local government requirements replace the EFPIA reporting requirement, …

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