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Data Protection General Data Protection Regulation (GDPR) Pharmaceutical Industry

Latham & Watkins LLP

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

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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

White & Case LLP

CJEU: Competitors Can Sue over Data Protection Violations

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The German Federal Court of Justice (Bundesgerichtshof), tasked with resolving a conflict between two competing pharmacists, sought guidance from the Court of Justice of the European Union ("CJEU") on interpreting the General...more

White & Case LLP

AI implementation & data protection regulation: German authorities publish guidelines for implementing AI in compliance with the...

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The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more

Gardner Law

[Ongoing Program] SESSION 3: Privacy Policy Pop Quiz – Are You Ready? - August 8th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 2: Do I Really Need A Privacy Officer, DPO or CISO? - July 18th, 1:00 pm - 1:45 pm CT

Gardner Law on

Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 1: 10 Things You Should Know About Privacy, Consent, and HIPAA - June 13th, 1:00 pm - 1:45 pm CT

Gardner Law on

Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Hogan Lovells

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

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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

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

Hogan Lovells

Ne manquez pas la consultation sur les référentiels Accès Précoce et Accès Compassionnel

Hogan Lovells on

Le 15 février 2022, la CNIL a publié deux projets de référentiels. Ces référentiels étaient très attendus car l’Autorisation Unique 041 sur les traitements de données personnelles dans le cadre des Autorisations Temporaires...more

McDermott Will & Schulte

International Legal Highlights - May 2021

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

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 & Schulte

Brexit Update - March 2019

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

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

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

Hogan Lovells

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

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On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....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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