During the 2nd Workshop of EEFAM: Medical – 18 April 2019, the regulatory framework for clinical trials (interventional and non-interventional) was presented with special emphasis of the current legislation on their proper and legal management in relation to the European Personal Data Regulation (GDPR) and the European Regulation οf Clinical Trials (CTRs) was analyzed taking

The establishment of stronger policies at a European level, the creation of more effective funding tools for national health systems and the implementation of reforming health expenditure interventions in Greece were some of the key issues discussed during the 9th Future of Healthcare Conference Greece http://www.healthcareconference.gr/, which took place on Wednesday 27/3/2019 at the Divani

Our law firm participated in the Health IT Conference and in particular Ioanna Michalopoulou was a speaker at the Round Table on “One Year From GDPR Implementation”. The process of compliance with the GDPR General Data Protection Regulation was discussed in detail by keynote speakers. What has been achieved, what is lacking, what is in

Ms Michalopoulou and Ms Chatziantoniou were called to contribute to this year’s edition due to their long and rich expertise in legal matters pertaining to the compliance of pharmaceutical companies with the local and european legislation. They succesfully described the legal framework of advertisement of pharmaceutical products in Greece and the way companies can comply

With just over half a year to go before the General Data Protection Regulation comes into effect, Ioanna Michalopoulou, Managing Partner at Michalopoulou & Associates, answers some questions about the forthcoming regulation. What are the implications of the GDPR for the healthcare industry? The General Data Protection Regulation (GDPR) introduces a new data protection map

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,

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.

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

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

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