o
The Challenges of Privacy — Corex Logistics 12 Oct 2022

The Challenges of Privacy

European GDPR requirements have been causing some concern to the FDA in terms of regulatory research reporting.


A blog post written by Heather Messick, currently a regulatory counsel in the FDA’s Office of Compounding Quality and Compliance, formerly of the FDA’s Europe Office, has outlined how BIMO – the FDA’s bioresearch monitoring programme overseeing the conduct and reporting of FDA-regulated research has been impacted by the European Data laws.


GDPR became law in Europe in 2018 to protect the collection and use of personal data of EU residents. Under the law, FDA investigators have found themselves facing challenges rendering completion of in-person BIMO investigations and conducting virtual data reviews impossible, saying that GDPR has impeded the ability to remotely review data during the pandemic, according to Messick.


Beyond BIMO, GDPR has also caused issues with the submission of data from clinical trials involving EU citizens – including valuable demographic data – which could potentially affect the robustness of information submitted to the FDA and have knock-on effects on product reviews and approvals. EU guidelines also mean that if a data subject withdraws consent to having their data processed, that any personal data relating to that subject be deleted or anonymised immediately. The FDA feels that this could compromise the integrity of the research overall.


Earlier this year, the EU and US agreed ‘in principle’ on a new agreement relating to the transfer of personal privacy data for commercial purposes but a full resolution has not yet been found. In the meantime, while they work toward a solution, the FDA Europe Office will be keeping a close eye on the situation.



Back to the list

ABOUT US

COREX Logistics is a supply and logistics company with headquarters in Ireland, working with pharma and patients to facilitate improved healthcare worldwide.

Our expert international team works across an 80-country network, specialising in the EMEA region, providing the latest in clinical trial logistics technology and systems, cold-chain delivery, temperature-controlled transportation and storage services. From sourcing, procurement and customs clearance, to labelling, returns and destruction, we cover every link in the supply chain. We also run an established Named Patient Programme and provide Patient-Oriented services. With extensive knowledge and on-the-ground insight into our markets, we create innovative solutions with the ultimate goal of improving the lives of patients.

To learn more about our range of expert services, contact us today on info@corex-logistics.com

If you found this article helpful, consider sharing it with others who might also benefit from it. Sharing knowledge is a wonderful thing to do and can be very helpful to others.

CONTACT US

We’re here to help.
Email us at info@corex-logistics.com or use our feedback form to send us your question.

This website uses cookies to improve user experience. By using our website you consent to all cookies in accordance with our Cookie Policy.