Publication date: October 23, 2025
Investigator status
The legal status of an investigator is determined based on Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and the Polish Act of 9 March 2023 on clinical trials on medicinal products for human use .
If a clinical trial is conducted by a team, the principal investigator is the primary investigator. If there is only one person responsible for conducting the clinical trial, the investigator is the primary investigator. This distinction is important because it determines who can, respectively, fulfill the roles of investigator and principal investigator.
The researcher may therefore be a doctor or, pursuant to Article 49 of Regulation 536/2014, a person exercising a profession with the necessary knowledge and experience in working with patients, who is permitted to be a researcher in a given Member State.
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Publication date: October 23, 2025
Using a specific image without the author’s consent means using images, photos, illustrations, or other graphic materials created by someone else without obtaining the appropriate consent for such use. Examples of illegal use of a graphic include sharing graphic materials without the author’s consent, using a graphic for commercial purposes (on websites) without obtaining the appropriate license, using someone else’s work as your own (posting it on your own social media profile), or modifying a graphic without obtaining the author’s consent.
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Publication date: October 23, 2025
Personal data breach – definition
Any activity that involves the processing of personally identifiable information is considered personal data processing. However, it’s important to remember that GDPR regulations do not apply to activities undertaken solely for personal or household purposes.
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Publication date: October 23, 2025
Recently, administrative courts have been considering the possibility of imposing VAT obligations on individuals and companies providing services via the SaaS model. This article provides an analysis of the nature of the SaaS model, its advantages and disadvantages, the legal obligations associated with it for both users and service providers and the latest administrative court case law related to this model.
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Publication date: October 23, 2025
KIEŁTYKA GŁADKOWSKI KG LEGAL participated in the conference “Longevity Biotech: Investing in a healthier future”. As part of its life science specialisation, our biotech and pharma lawyers offer comprehensive legal services to its clients in many areas of law, including extensive legal services to companies operating in the longevity biotech sector and biotech companies engaged in life extension and human health. Within this specialism our law firm offers assistance in respect of trademark protection and patent issues, regulatory law, certification, contractual, and litigation and arbitration issues. At KG Legal, we know that a key role in the biotechnology sector is innovation and responsiveness to changing market needs. Therefore, we offer our clients a proactive approach, flexibility and efficiency in action. All these qualities of our firm make us recognized as one of the leading law firms in Poland and the world, especially in the field of cross-border specialization and knowledge.
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