Belgique | Arrêté royal portant exécution du Sunshine Act

PHILIPPE, Roi des Belges, A tous, présents et à venir, Salut. Vu l’article 108 de la Constitution; Vu la loi du 18 décembre 2016 portant des dispositions diverses en matière de santé, articles 42, § 1er, alinéa 2, et § 2, alinéa 2, 43, § 1er, alinéa 5, et 48, §§ 1er et 2; Vu les avis de l’Inspection des Finances, donnés le 21 février 2017 et le 26 avril 2017; Vu les avis n° 61.113/2 et n° 61.458/2 du Conseil d’Etat, respectivement donnés le 5 avril 2017 et le 29 mai 2017, en application de l’article 84, § 1er, …

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Webinar | Using Analytics For Business/Compliance Monitoring At Roche, Italy

For organizations with a multi-market presence, the relationship between Data, Analytics and Transparency can be a complex one. Using Analytics For Business/Compliance Monitoring At Roche, Italy In this webinar, the presenters describe the various ways such organizations can use Transparency Data, and how that subsequently directs evolution in their Business Direction/Model. Presenters will also draw from Roche Italy’s own experiences in showing the advantages of using Transparency Data, the various forms of Compliance and the benefits of Substantial Compliance. Click here for further information.

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New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices. The transparency obligation laid down in the Sunshine Act applies to all entities engaged in an economic activity, regardless of their legal status and the way in which they are financed. The obligation applies: to marketing authorisation holders for medicinal products for human or veterinary use; to importers, manufacturers and distributors …

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Le Sunshine Act Belge – Belgium Sunshine Act

CHAPITRE 1er. – Sunshine act Art. 41. § 1er. Pour l’application du présent chapitre, on entend par : 1° « entreprise soumise à notification » : toute entité qui exerce une activité économique, indépendamment de sa forme juridique et de la manière dont elle est financée, au sens du titre VII du traité concernant le fonctionnement de l’Union Européenne, notamment les titulaires d’autorisation de mise sur le marché des médicaments à usage humain ou vétérinaire, les importateurs, les fabricants et distributeurs de médicaments à usage humain ou vétérinaire, les personnes exerçant des activités de courtage de médicaments à usage humain ou vétérinaire, …

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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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