News & Analysis as of

Data Protection General Data Protection Regulation (GDPR) Clinical Trials

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Hogan Lovells

Pharmacovigilance in Spain: Takeaways from the new code of conduct (Part 2)

Hogan Lovells on

Some weeks ago, we described the highlights of the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance" (CoC) and the impact on data...more

Hogan Lovells

Long-awaited update of the French “Convention Unique” for clinical trials finally published

Hogan Lovells on

A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more

Hogan Lovells

Clinical trials in Spain: Takeaways from the new code of conduct (Part 1)

Hogan Lovells on

Last week we raised our hands to inform you about the Spanish Data Protection Authority’s approval of the "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well...more

Hogan Lovells

ICO consults on new guidance for conducting scientific research under the UK GDPR

Hogan Lovells on

Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more

Hogan Lovells

Heads up! New Spanish Code of Conduct on personal data in clinical trials and pharmacovigilance

Hogan Lovells on

The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more

Alston & Bird

Major Overhaul of EU Clinical Trial Rules Kicks In on 31 January 2022

Alston & Bird on

On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory...more

Butler Snow LLP

International Privacy Laws and Clinical Trials

Butler Snow LLP on

Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

Hogan Lovells

EDPB’s New Guidelines – Clinical Trials in the EU and COVID-19

Hogan Lovells on

We currently live in a world where the rapid spread of COVID-19 has provoked the urge to initiate the search for an effective vaccine or medicines to fight against it....more

Hogan Lovells

Medical Research Council Advises on How to Anonymise Information for Research Purposes

Hogan Lovells on

Anonymisation has always been (and still is) a real challenge for those carrying out clinical research. To shed some light on this matter, the Medical Research Council (MCR) – which is part of UK Research and Innovation – has...more

Hogan Lovells

GDPR – The Year in Review

Hogan Lovells on

Following the one-year anniversary of the coming into effect of the GDPR, Hogan Lovells’ Privacy and Cybersecurity practice has prepared a compilation of key GDPR-related developments of the past 12 months. The compilation...more

Hogan Lovells

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

Hogan Lovells on

Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more

Foley Hoag LLP - Security, Privacy and the...

EDPB Issues Opinion on the Interplay between the Clinical Trials Regulation and the GDPR

On January 23, 2019, the European Data Protection Board (“EDPB”) issued an interesting opinion about personal data processed in relation to clinical trials. The main role of the EDPB – which succeeded the Article 29...more

WilmerHale

The Legal Basis for Processing Personal Data in the Context of Clinical Trials in the EU: The European Data Protection Board...

WilmerHale on

On January 23, 2019, the European Data Protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, adopted an Advisory Opinion...more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

Hogan Lovells on

With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

WilmerHale

Data Protection Rules Could Seriously Impede Clinical Trials in Europe

WilmerHale on

The European Data protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, recently adopted an Advisory Opinion (“Opinion”) on...more

Fox Rothschild LLP

European Regulator Provides Guidance On Conducting Clinical Trials Under The General Data Protection Regulation

Fox Rothschild LLP on

Companies conducting clinical trials in the EU have been grappling with many questions regarding how to conduct a clinical trial that complies with the requirements of the GDPR. Two key questions have arisen: What is the...more

Fox Rothschild LLP

European Data Protection Board Issues Opinion On Data Processing For Clinical Trials

Fox Rothschild LLP on

Clinical trials and the EU General Data Protection Regulation (GDPR): The European Data Protection Board (EDPB) has issued a much-awaited opinion on the legal basis for processing clinical trial data....more

Hogan Lovells

California Consumer Privacy Act: The Challenge Ahead — Introduction to Hogan Lovells’ Blog Series

Hogan Lovells on

Groundbreaking. Watershed. Unprecedented. - We have heard the California Consumer Privacy Act of 2018 (CCPA) called all these things and more since its enactment on June 28, ?2018. Our experience to date has confirmed the...more

Morgan Lewis

European Life Sciences Review: Issue 3

Morgan Lewis on

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

20 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide