Mgr. Martin Schimmer

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Legal aspects of funding and insurance of clinical research and of liability of sponsors, investigators and healthcare institutions.

The article is addressing general legal principles and practical experience in funding of clinical trial of human medicines in relations between sponsors and investigators/healthcare institutions (investigators´ and healthcare institutions´ fees, aspects of remunerating of investigation team of the investigator, short description of tax impacts), as well as in relations between sponsors and trial subjects (patients) including questions of providing compensation to these subjects for their participation in a clinical trial. The article further deals with general principles and practical experience with clinical trial insurance with respect to obligations of sponsors in negotiating such insurance, its types, extent and acceptability of particular variants if insurance in the light of statutory regulation and assessment of ethics committees. Furthermore the article addresses liability for damage caused to clinical subjects (patients) especially from the view of legal background of this liability.

Mgr. Martin Schimmer

Mgr. Martin Schimmer was born on 12 March 1980 in Prague, where he also completed his studies at the Faculty of Law of the Charles University. Martin Schimmer is a partner of the Law firm Marečková specialized in legal services in the field of pharmacy law in a wider sense (legislativ regarding the regulativ of curative preparations, nutrition suplements and medici device) and health law (focusing on the functioning of business entities in this field).

Professional activities of Martin Schimmer are focused on the field of regulation of advertisment of curative preparations, regulation of the entry into the market of such goods, including obtaining payments from resources of public health insurance, and on legal relations foregoing the introduction of curative preparations on the market, especially in the process of clinical evaluation of curative preparation, including contractual relations and accountability mechanisms and issues of insurance of clinical evaluations.

Together with colleagues from the office he is the author of an e-learning educational course for pharmacists and a regular lecture round Current Issues of Pharmacy Law. Concurrently, he gives lectures and participates in academic conferences organised by third parties.

Mgr. Martin Jarolín

Mgr. Martin Jarolín was born on 1 October 1979 in Ilava, Slovakia. In 2005 he graduated from the Faculty of Law of the Comenius University in Bratislava. At present he works as a permanently co-operating attorney at law of the Law firm Marečková in Prague, which has a professional focus on fields of medications law, law of medical devices, nutrition supplements and cosmetics, law of healthcare providing, payments of healthcare expenses from funds of public health insurance and other related fields.

Within his activities, Martin Jarolín focuses on the field of clinical drug trials phase III and IV including non-intervention clinical trials and post-registration precautionary monitoring of drugs, further on the field of advertisement of nutrition supplements, drugs and medical devices, commercial-law aspect of legal relations arising in these fields.

Contact

Mgr. Martin Schimmer
T: +420 222 969 365
E: schimmer@akmareckova.cz

Contact

Mgr. Martin Jarolín
T: +420 222 001 736
E: jarolin@akmareckova.cz

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ORGANIZERS OF THE CONFERENCE	PROFESSIONAL COOPERATION	WITH SUPPORT OF