May 19th 2015: Ιoanna Michalopoulou has presented key aspects on Healthcare Compliance at Global Medtech Compliance Conference in Athens. Sales and Marketing ethics in the Healthcare sector: analysis on the standing anticorruption, competition and antitrust law. Legal advantages by adopting Global Medtech soft law and guidelines on how each healthcare company may implement its own
During the recent EU Healthcare, Ethics & Regulation Compliance Program I attended and which was held last November by the University of Seton Hall in Paris, all the latest and important legal developments in the Medical Law field were discussed thoroughly and varying points were raised from major European and US Health Law firms. FCPA’S
In the last few years, there has been an alarming increase of falsified medicinal products in Europe. Falsified medicines are medicines with a false representation of their identity, source and history -medicines therefore which pass themselves as real, authorized medicines. In particular, falsified medicines might contain ingredients which are of bad quality or in wrong
Extensive Web use has become a global phenomenon which has nonetheless brought to surface certain issues -personal data protection being one of them. The health industry is certainly positively influenced by the increasing new technological developments that lead to the improvement of medical services. Although the design of websites, accessible both to Healthcare Professionals and
Health-related web research may be efficient; however, it entails the risk of misinformation both for the general public and for health care professionals (HCP). At the same time, social media tools such as Facebook and Twitter have introduced a whole new set of changes regarding the advertising of medicinal products and medical devices. A harmonized
Medical device advertising lacks harmonization within the EU as there is no specific chapter nor any particular EU legislation dedicated either to advertising or to the promotion of medical devices. The general legal European framework for medical devices (MD) includes three Medical Devices Directives -Directive 93/42/EEC, Directive 90/385/EEC and Directive 98/79/EEC- which focus on the
Α.The advertising of medicinal products.   The Directive 2001/83/EC on the Community Code relating to medicinal products for human use provides a harmonized framework for the advertising and promotion of medicines. The directive has been implemented to Greek law via Ministerial Decision ΔΥΓ3α/οικ.82161.   According to the Directive’s Article 86, “advertising of medicinal products shall include
“Foremost, corrupt countries are less safe.  Corruption thwarts economic development, traps entire populations in poverty, and leaves countries without a credible justice system.  Corrupt officials who put their personal enrichment before the benefit of their citizenry create unstable countries.”  Leslie Caldwel, Assistant US Attorney General, North Carolina, October 2014. During the recent EU Healthcare Ethics
We are glad to announce that Mrs. Ioanna Michalopoulou LL.M. has been certified by Seton Hall University in EU Healthcare Compliance, Ethics & Regulation following her participation in the EU Compliance Program, which took place  in Paris on 17-21st November 2014.
The new law (4281/2014) on Public Procurements was published on the 8th of August, 2014. In its second part, the new law incorporates the EC Regulation 1336/2013 which in turn amended Directives 2004/17/EC, 2004/18/EC and 2009/81/EC of the European Parliament and the EU Council. The new law foresees rules in awarding public contracts and was
The European Federation of Pharmaceuticals Industries and Associations (EFPIA), based on the Treaty of European Union, represents today most of the pharmaceutical companies in Europe, performing a mainly scientific role. Its purpose is to facilitate the release of medical products in Europe and to work towards the improvement of human health. EFPIA believes that this
It is well-known that in order for a drug to freely circulate in the market, it must have received a circulation permit that ensures its harmless and competent character.  For this reason, along with the permit application, the full results of pharmacological, toxicological and clinical tests must be submitted for approval. It’s worth noting however,
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