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.
On May 27, 2021 KG Legal Kiełtyka Gładkowski is taking part in the networking event “Connecting Tech Markets around the World”, organized by the Tech M&A Committee of ITechLaw association.
The event will be devoted to the presentation of different local tech markets and related legal issues – in particular in regard to international Technology M&A transactions. The topics will be presented by speakers who are the specialist in the local tech markets.
The moderator of the event is Mitko Karushkov, Technology and Transactional lawyer at Mitko Karushkov, Bulgaria. Mitko Karushkov has been practicing legal solution provision for over 20 years. He renders legal and business advice to technology companies or companies using technology in their operations. Mitko’s main areas of practice include data protection, intellectual property, M&A and related transactional work and advice, information security, regulatory & compliance work for telecommunication companies present in Bulgaria and Europe. Mitko Karushkov is a recommended data protection expert by Bloomberg BNA, USA.
On May 20, 2021 KG Legal Kiełtyka Gładkowski is taking part in the live webinar “Disputes In Space: Mediate and Arbitrate” organized by ITechLaw organization.
The main topic of the event will be the discussion on resolving customer disputes and issues in a thriving aviation industry. The experts will discuss the issues of out-of-court settlement of disputes in order to work out the most advantageous solution for the client.
On May 18, 2021 KG Legal Kiełtyka Gładkowski is taking part in the live webinar “Negotiating Cloud Computing Contracts Hosted by Technology Sourcing Committee” conducted by ITechLaw Technology Sourcing Committee.
The main topic of the event will be a discussion about pragmatic ways to negotiate the cloud computing contracts including the often tricky aspect of audit rights. Hosted speakers will explain the concerns of cloud vendors and customers and provide practical guidance about what provisions may be negotiable, and how to manage and mitigate risks, especially around those provisions which cloud vendors rarely move on. The participants will be able to learn how far cloud vendors are willing to go to address regulatory requirements for customers of cloud services to ensure that customers and/or the relevant regulator have a right to conduct audits. Invited speakers are valued lawyers specialized in technology law.
