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.
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.
Under EU Law, namely Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (hereinafter “GDPR”) and the pending entry into application of Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directive 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (hereinafter “AIA”), the use of sensitive data (including medical data) for AI training would only be possible after obtaining consent, in cases specified by law, or when using anonymized data. AIA is not a lex specialis vis-à-vis the GDPR, so when using personally identifiable data, using data for AI model training requires meeting the requirements of both acts.
The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.
