Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
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
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
The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more
In David Fogel’s published review of 30 years of clinical trial research operations, he sums up the likelihood of study success by saying: “Clinical trials for pharmaceuticals and medical devices offer many...more
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
MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
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
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
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
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
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
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
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
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
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
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
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
European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data. In January, the European Data Protection Board (EDPB)...more
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
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
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
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
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
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
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