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Harmonising Requirements in the EU

In 2018, a new regulation protecting citizens’ privacy came into play. The European Parliament and European Council jointly adopted the GDPR on 27 April 2016 and the Regulation (EU) 2016/679 (GDPR) came into force on 25 May 2018. In essence, this important regulation gives European citizens more control over their own personal data. At the same time, the Clinical Trial Regulation (EU) 536/2014 (CTR) – which will come into force in 2021, once the clinical trials information system becomes fully functional – will reinforce the obligation of publishing data from all clinical trials submitted for marketing authorisation applications to the EMA, regardless of their success or failure. Biopharma industry experts and regulators have debated strategies for the concurrent implementation of GDPR and CTR across the entire product development lifecycle, and considerations abound.

CTR and GDPR Interplay

The interplay between the CTR and the GDPR causes confusion when attempting to understand and interpret both regulations between the member states, institutions, and regulatory authorities involved (1-2). It has been mentioned that in order to strictly comply with the GDPR, each organisation should clearly define its role as ‘data controller’ or ‘data processor’ under the GDPR and subsequently carry out only those tasks that are applicable for a specific role under the regulation. However, it seems that for many stakeholders involved in clinical research, it is still unclear who these data controllers/ processors or joint controllers are and their respective roles.

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About the author

Magdalena Lewandowska is a Scientific Programmes Specialist at DIA, where she collaborates with international experts on the content development for the DIA educational portfolio. She enjoys clinical research and approaches all projects assigned to her with passion, ambition, and commitment. After spending more than 10 years working in healthcare organisations and in the pharma industry, she gained a great understanding of the drug development process as well as GCP guidelines, data collection, and analysis. Magda holds a BA Degree in Marketing as well as postgraduate certification in Conduct and Management of Clinical Trials from the University of Basel, Switzerland. She has also completed several other courses in areas such as European and US Regulatory Affairs, GCP, and Statistics.
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