home > ict > winter 2020 > harmonising requirements in the eu
International Clinical Trials

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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

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.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations. Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.
More info >>

White Papers

The Impact of Components on Drug Quality and Risk Mitigation

West Pharmaceutical Services, Inc.

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
More info >>

Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement