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Consent Clinical Trials

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

Master(ing) Protocols for Randomized Umbrella and Platform Trials

Goodwin on

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more

Foley & Lardner LLP

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more

MoFo Life Sciences

Key Considerations For Sponsors Of Clinical Trials Under The EU Clinical Trial Regulation

MoFo Life Sciences on

Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

Jones Day

JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials

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Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more

Dechert LLP

GDPR and the EU Clinical Trials Regulation

Dechert LLP on

On 23 January 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the EU General Data Protection Regulation (“GDPR”) and the EU Clinical Trials Regulation (“CTR”). The CTR is not yet...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

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

BakerHostetler

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

BakerHostetler on

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

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