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Risk Management Life Sciences

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Woodruff Sawyer

Navigating Insurance for Artificial Intelligence and Life Science Products

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Life science companies are tapping into artificial intelligence (AI) to improve how they work, transforming the way they handle data and approach product research and development. They’re using AI to speed up key processes...more

Hogan Lovells

China’s healthcare compliance guidelines: insights and actionable steps for life sciences companies

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In January 2025, China’s State Administration for Market Regulation (“SAMR”) introduced the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Guidelines”), marking the first...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: IP Litigation and Trials

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the tenth episode of When Your Life Sciences Are on the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 241: Fighting Nurse Burnout with Data-Driven Innovation...

Maynard Nexsen on

In this episode, hosts Lynnsey and Lauren are joined by Dr. Ecoee Rooney, Chief Nursing Officer at Indicator Sciences and a nationally recognized leader in nursing innovation. Dr. Rooney shares how her team is tackling nurse...more

American Conference Institute (ACI)

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

Woodruff Sawyer

Life Sciences Insurance: Navigating Risk from Lab to IPO

Woodruff Sawyer on

In our new webinar series, Risk Management for Your Life Sciences Company, we discuss the insurance and risk management milestones life science companies should prepare for as they move from early funding through clinical...more

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

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

DOJ’s “Bulk Sensitive Data Rule” is in Effect, and May Require Significant Compliance Obligations as Enforcement is Set to Begin

Pursuant to a newly effective U.S. Department of Justice (DOJ) regulation, the transfer and storage of certain sensitive U.S. government and personal data may be prohibited or restricted, depending on the intended recipient,...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 3 - International Clinical Trials Country Requirements-...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 2 - AI In Real Life (Science): Exploring Real World...

Woodruff Sawyer on

From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 1 - Navigating Risk from Lab to IPO: A Guide to...

Woodruff Sawyer on

From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

Cargo Stock Throughput Insurance for Life Science Companies

Woodruff Sawyer on

In the dynamic world of life sciences, companies face unique challenges in safeguarding their valuable assets. From pharmaceuticals to biologics, medical devices to vaccines, these products often require specialized handling...more

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

Hogan Lovells on

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

MoFo Life Sciences

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

MoFo Life Sciences on

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more

Venable LLP

Addressing Insider Threats to Intellectual Property

Venable LLP on

Want to learn more about drafting, negotiating, and understanding intellectual property and technology contracts and have 10 minutes to spare? Grab your morning coffee or afternoon tea and dig into our Tech Contract Quick...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When...

In this episode, Michael Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

Gardner Law

From Paper to Practice: Compliance Policies that Work

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In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more

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