On January 31, 2022, the Regulation of the European Parliament and the Council of the European Union on clinical trials of medicinal products for human use came into force, repealing Directive 2001/20/EC at the same time.
What the CTR actually is?
The Clinical Trials Regulation is a regulation containing provisions on clinical trials. To better understand the whole problem, it is necessary to consider what they are and what aspects clinical trials contain.
“Clinical trial” means a clinical study – any investigation in relation to humans intended to discover or verify effects of one or more medicinal products, to determine safety and effectiveness of those medicinal products. The former concept of clinical trial needed to be clarified by introducing a broader concept of biomedical research. The issue of the terms introduced in the Regulation will be discussed in more detail at the end of the article.
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With the accession to the European Union, Poland faced many challenges. With them, however, many opportunities arose. The country was enabled to be part of the European financial market, including the investment fund market. Within the Union, work is constantly being carried out to unify the regulations so that it is possible to conduct business successfully in every member state.
The cons iderations on an AIFM passport should begin with explaining what AIFM is, setting out the background, specificities of the European fund market and the regulations on which the passport is based.
All about AIFM
What is AIFM? The AIFM acronym stands for the Alternative Investment Fund Manager. That is a legal person legal that conduct business activity in the area of the professional management of investment funds.
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On September 20, 2022 KIELTYKA GLADKOWSKI KG LEGAL will take place in webinar dedicated to remote patient monitoring. The webinar will be organized by MedCity and Huma (https://huma.com/about), a global digital health company. Huma’s modular remote monitoring platform helps medtech companies to realize new value, from developing patient relationships to providing real world evidence around peri operative procedures.
The webinar will highlight three aspects of remote monitoring:
Real world data collection
Supercharging patient engagement
Navigating the regulatory landscape
A recent report from Rock Health noted that only 50% of digital health companies collect real world evidence. On the flip side, medtech companies on the whole have yet to realize the value of digital health tech. The webinar will also explore use cases in episodic care, diagnostic care and chronic care.
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On 28 September 2022 KG LEGAL KIELTYKA GLADKOWSKI’s financial team will take part in the webinar on Digital Assets Business, presented by Bahamas Securities Commission. Bahamas Securities Commission will present framework for Digital Assets Business, as well as an interactive session with Christina R. Rolle, Executive Director, Securities Commission of The Bahamas.
With its groundbreaking Digital Assets and Registered Exchanges Bill (DARE Bill) in 2020 and the Government’s 2020 white paper “The Future of Digital Assets in The Bahamas”, The Bahamas has managed to lay a wide regulatory foundation for digital assets. This includes the facilitation of digital token exchange registration and the provision of services related to them, the regulation of digital assets-based payment service businesses, and for the registration of financial services related to the creation, issuance or sale of digital tokens and other digital assets.
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The Polish General Inspector of Financial Information (GIFI) is the main element of the Polish system of counteracting money laundering and financing of terrorism. In the performance of its statutory tasks, the GIFI is assisted by the Polish Financial Information Department of the Ministry of Finance. The GIFI, together with the Department, is considered a financial intelligence unit as defined in the regulations of the European Union.
The Polish General Inspector of Financial Information accepts reports of actual or potential violations of the provisions on counteracting money laundering and terrorist financing from employees, former employees of obligated institutions or other persons who perform or performed activities for the obligated institutions on a basis other than an employment relationship.
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