Media & Events

 

Βusiness Partners: Law and (a new) Order

Posted by on 8 June, 2017

Βusiness Partners: Law and (a new) Order

The digitalization of healthcare business and the move towards a more patient-focused healthcare is gathering speed. Telemedicine, online medicine purchases, personalized health systems for remote patient monitoring, integrated health information systems, electronic health records, e-prescription, e-referrals have already been established in many countries and have gained in popularity – even in Greece. Given these developments, one would expect significant legislative upheaval. Besides, the existing Greek legal framework, first adopted in...

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Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (EU/US)

Posted by on 14 January, 2016

Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (EU/US)

Get a quick, up to date overview of the Biotechnology industry and particularly “Red” Biotechnology and gain an understanding of the legal challenges the industry faces right now. Case studies, entrepreneurial examples and referrals to the current regulatory issues act as a starting point to delve deeper into that booming industry.

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Healthcare Compliance : A Paradigm Shift in the way of doing business in Greece

Posted by on 23 June, 2015

Healthcare Compliance : A Paradigm Shift in the way of doing business in Greece

The call to systemic reform in the healthcare industry towards more compliance is loud and clear in both the EU and the US. It could easily therefore make a great policy opportunity in the Greek case. But the prerequisite to any reform is actual forming in the first place. Unfortunately, the recent Health Transparency Law 4316/2014 is in dire need of guidance, however solid in its base principles. Expected Ministerial Decisions and EOF circulars have not been issued yet in order to facilitate its implementation by pharmaceutical companies....

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Life Sciences Compliance Breakfast

Posted by on 22 June, 2015

Life Sciences Compliance Breakfast

A speech by Mrs Ioanna Michalopoulou on Ernst & Young’s “1st Life Sciences Compliance Breakfast” dealing with Pharma Compliance, a rapidly important issue in Greece. During the panel, compliance-related issues such as competition, public tenders, advertising and e-Health were discussed – along with the landmark German Court decision on awarding civil compensation to a Board Member responsible for Compliance issues.

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GMTCC 2015: Best Legal Practices

Posted by on 22 June, 2015

GMTCC 2015: Best Legal Practices

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 compliance program tailored to her unique needs and...

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EU Healthcare Compliance, Ethics & Regulation –The latest developments

Posted by on 13 May, 2015

EU Healthcare Compliance, Ethics & Regulation –The latest developments

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 consequences in Europe- EFPIA-EUCOMED The provisions of FCPA (Foreign Corrupt Practices Act), which prohibits the bribery of foreign government officials and foresees the accountability of books, are...

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Common Logo for websites of legally operating Online Pharmacies

Posted by on 7 May, 2015

Common Logo for websites of legally operating Online Pharmacies

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 dosage. For these reasons they are a major threat to public threat and safety. The legal framework regarding falsified medicines is set out in Directive 2011/62/EC which...

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Data Protection on the Web & E-Health

Posted by on 16 April, 2015

Data Protection on the Web & E-Health

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 the general public, as well as the creation of medical apps represent new information sources, they also create several problems regarding the processing, storage...

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Advertising in the health industry: the legal framework and latest developments C. Internet and Social Media Tools

Posted by on 17 March, 2015

Advertising in the health industry: the legal framework and latest developments C. Internet and Social Media Tools

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 European legal framework does not exist for online advertising (websites, blogs, apps and social media); jurisprudence on this matter is so far very limited. In this context, EFPIA’s guidelines...

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Advertising in the Health Industry: the legal framework and latest developments B. Medical device advertising

Posted by on 10 March, 2015

Advertising in the Health Industry: the legal framework and latest developments B. Medical device advertising

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 requirements and obligations for placing devices on the market; they also introduce a general rule, according to which a manufacturer may market only MD that...

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