Laboratory research in science and medical setting.
The 26th of May 2021 will mark the first day that the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (later ‘Regulation 2017/745’) will fully apply after the 4 years transitional period. This regulation concerns medical devices – that are also regulated in Poland in the Medical Devices Act of 20 May 2010 (later MDA).
Medicinal Products, on the other hand, are regulated in Poland in the Pharmaceutical Law Act of 6 September 2001 (later PLA). Medicinal products are also regulated by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (later ‘Directive 2001/83/EC’) and the Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (later ‘Regulation 726/2004’).
Article 117 of the Regulation (EU) 2017/745 introduces significant changes for some combination products.
Polish Medical Research Agency is the Polish state agency whose tasks include development of scientific research in the field of medical and health sciences. Its main goal is to build an innovative healthcare system, which will contribute to a better way of meeting society’s needs through assessing which new medical technologies and therapeutic methods should be used.
Currently, the Agency implements one of the first public grant programmes that finances non-commercial clinical trials in Poland. The Agency has planned five calls for proposals for the year 2021 – two which have recently closed, concerning clinical research in rare diseases and creating and further developing Clinical Research Support Centres, and three the details of which are yet to be announced, concerning clinical research in psychiatry and neurology (second quarter of 2021), development of innovative therapeutic solutions that use the RNA technology (May 2021) and prevention and curing of civilisation diseases (third quarter of 2021).
Polish Clinical Research Development Centre
The development of the Polish Clinical Research Support Centres is one of the projects of the Clinical Research Development Centre. The main goal of CRDC is to initiate and support the activities that aim to remove the barriers in clinical research development in Poland. From its beginnings, the Centre has been analysing and defining the scope and direction of changes to optimise the clinical research market in Poland and supporting the development of said research.
The Medical Research Agency (MRA) is a Polish state agency, which tasks include development of scientific research in the field of medical and health sciences. Its main goal is to build an innovative healthcare system, which will contribute to a better way of meeting society’s needs through assessing which new medical technologies and therapeutic methods should be used.
Currently, the Agency implements one of the first public grant programmes that finances non-commercial clinical trials in Poland. The Agency has planned five calls for proposals for the year 2021 – two which have recently closed, concerning clinical research in rare diseases and creating and further developing Clinical Research Support Centres, and three which details are yet to be announced, concerning clinical research in psychiatry and neurology (second quarter of 2021), development of innovative therapeutic solutions that use the RNA technology (may 2021) and prevention and curing of civilisation diseases (third quarter of 2021).
Clinical Research Development Centre
The development of aforementioned Clinical Research Support Centres is one of the projects of the Clinical Research Development Centre (CRDC). The main goal of CRDC is to initiate and support the activities that aim to remove the barriers in clinical research development in Poland. From its beginnings, The Centre has been analysing and defining the scope and direction of changes to optimise the clinical research market in Poland and supporting the development of said research.
On 20 – 22 April, 2021 KG Legal founding partners, Małgorzata Kiełtyka and K. Jakub Gładkowski are participating in the Conference The health + wealth of America initiative held.
In relation to the new venture of KIEŁTYKA GŁADKOWSKI in the form of iStart-1 accelerator based in Singapore, aimed at financing start-ups from Eastern Europe primarily in the life sciences and new technologies industry
KIEŁTYKA GŁADKOWSKI kindly informs that as a member of the LIFE SCIENCE KRAKÓW CLUSTER it has received an invitation to participate in a meeting of the Bioeconomy thematic group, which is aimed at preliminary preparation for the implementation of the SmartLab workshops, including discussing the goals and expectations of participants, cooperation rules and related projects.
The meeting is addressed to everyone interested in the topic of bioeconomy, with particular emphasis on the topic of “industrial symbiosis” and the value chain “biopolymers”.
The series of SmartLab workshops, planned from May 2021, will be implemented in the context of the Regional Innovation Strategy, and its main goal is to develop paths for the development of technologies with high business potential.
