Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 199: Bringing Awareness to Organ and Tissue Donation with Dave DeStefano of We Are Sharing Hope
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 198: Artificial Intelligence in Healthcare and Life Sciences with hosts Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh and Randi Branham of Elliott Davis
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 191: South Carolina Lowcountry Healthcare with Walter Bennet, MUSC Orangeburg CEO
The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more
Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...more
Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more
In this dynamic global landscape, investors have always been required to make savvy, smart choices. This requires navigating through the intricate web of bilateral treaty protection, exploring the vital role these agreements...more
On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
Following a public consultation period this summer, the European Medicines Agency (EMA) published revised transparency rules (s. here) for the EU Clinical Trials Information System (CTIS) on 6 October 2023. The CTIS serves as...more
In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more
In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more
Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de janvier 2023. Ces Actualités législatives et...more
Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de novembre 2022. Ces Actualités législatives et...more
From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection of vulnerable groups This part of the series is about the protection of the...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
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more
Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more
Key Takeaways - A new draft EU Regulation aims to encourage the sharing and re-use of data and foster a data-driven economy that shares the benefits of Big Data whilst respecting individuals’ rights in personal data and...more
In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more
On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
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
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...more
On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...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