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European Union › General Data Protection Regulation (GDPR) › Pharmaceutical Industry

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
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

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

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Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Goodwin

What’s Next for AI? Six Areas to Watch in 2024

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Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

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Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Hogan Lovells

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

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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

McDermott Will & Emery

International Legal Highlights - May 2021

McDermott Will & Emery on

Expect More Criminal Enforcement & What You Can Do To Minimize Your Risk - Antitrust cartel and related collusive scheme enforcement is poised to increase. Several factors support this: (1) the Antitrust Division (the...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Skadden, Arps, Slate, Meagher & Flom LLP on

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

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Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Akin Gump Strauss Hauer & Feld LLP on

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

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This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

Hogan Lovells

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

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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

McDermott Will & Emery

Brexit Update - March 2019

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SPECIAL REPORT - BREXIT: CHALLENGES AND OPPORTUNITIES - In this report, we explain some of the key legal implications associated with the United Kingdom leaving the European Union (EU) without a deal for future...more

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

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

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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

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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

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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

Robins Kaplan LLP

Your Daily Dose of Financial News

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As expected based on buzz from late last week, longtime CBS chief Les Moonves is out at the network he’s led for more than 20 years.  While his exit has been in the works for some time, a report out yesterday detailing new...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...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

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