News & Analysis as of

Research and Development Risk Management

Fenwick & West LLP

Navigating and Litigating 'Commercially Reasonable Efforts' Provisions: Considerations and Strategies for Tech & Life Sciences...

Fenwick & West LLP on

Commercially reasonable efforts (CRE) provisions are a common feature in technology and life sciences agreements, particularly in development collaborations, licensing deals, and milestone-based contracts. ...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

Gardner Law on

In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

Goodwin on

Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - September 9th - 12th, Las Vegas, NV

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more

White & Case LLP

AI Watch: Global regulatory tracker - OECD

White & Case LLP on

The OECD's AI recommendations encourage Member States to uphold principles of trustworthy AI. Laws/Regulations directly regulating AI (the “AI Regulations”) The OECD's Recommendation of the Council on Artificial...more

Fenwick & West LLP

Balancing AI-Powered Drug Discovery’s Risk and Reward

Fenwick & West LLP on

AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more

Mintz - Antitrust Viewpoints

AI Provisions in Biden’s FY 2025 Budget Proposal — AI: The Washington Report

President Joe Biden’s fiscal year (FY) 2025 budget proposal includes hundreds of millions of dollars allocated towards executive branch AI efforts. The budget proposal’s AI-related provisions can be sorted into three...more

Health Care Compliance Association (HCCA)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

NAVEX

Risk Management 101: The Human Touch

NAVEX on

In the first part of Risk Management 101, we focused on the foundational elements of risk management. In part two, we’ll look at how the people who keep your organization running, with their unique insights, skills and...more

Akin Gump Strauss Hauer & Feld LLP

NIST Zeroes In on AI: New Government Actions to Keep Up with Rapid Tech Advance

In response to the exponential growth of artificial intelligence (AI) technologies over the past few years, the United States (U.S.) Department of Commerce’s National Institute of Standards and Technology (NIST) has been...more

DarrowEverett LLP

Florida Business Climate Great for Pickleball, But Risks Are in Play

DarrowEverett LLP on

When discussing the ever-evolving landscape of Florida’s commercial real estate (CRE) market, one trend has begun to stand out — the rise of pickleball. This sport, once a leisurely pastime, has turned into a compelling...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Akin Gump Strauss Hauer & Feld LLP

Senate Majority Leader Schumer Continues Push for AI Framework

On Wednesday, June 21, 2023, Senate Majority Leader Chuck Schumer (D-NY) unveiled the five policy objectives underpinning his ongoing work on a legislative framework to regulate Artificial Intelligence (AI)—the Security,...more

Bradley Arant Boult Cummings LLP

Accountable AI Systems through Risk Management:  NIST Creates Inaugural Framework with Principles and Playbook

On January 26, 2023, the U.S. National Institute of Standards and Technology (NIST) released the Artificial Intelligence (AI) Risk Management Framework (AI Risk Management Framework 1.0), a voluntary guidance document for...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 6th - 9th, Phoenix, AZ

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program designed to help attendees increase their ability to manage effective compliance programs. Our faculty of experts provides...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - December 5th - 8th, Anaheim, CA

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

American Conference Institute (ACI)

[Complimentary Webinar] Mitigating Sanctions and Export Control Risks for Life Sciences, Research Institutes and Universities -...

Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more

McDermott Will & Emery

[Ongoing Program] Precision Health: Trends And Future Potential - Possibilities and Pitfalls: Reimbursement and Regulatory Issues...

Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Health Care Compliance Association (HCCA)

MITRE: Risk Approach May Thwart Foreign Threats, Better Federal Info, Support Essential

Report on Research Compliance 18, no. 2 (February 2021) - “I don’t want to be on the front page of the paper with my best researcher being dragged off in handcuffs. It doesn’t look good for our university,” a senior...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - June 1st - 3rd

Due to the COVID-19 pandemic, our Research Compliance Conference will be held virtually. Attendees will enjoy Research compliance sessions and industry updates in an interactive, online experience, plus have the opportunity...more

Hogan Lovells

[Event] Privacy and Cybersecurity KnowledgeShare – September 19th, London, UK

Hogan Lovells on

Join us on Thursday 19 September for the Hogan Lovells Privacy and Cybersecurity KnowledgeShare in London. We will share our latest thinking on the key privacy and cybersecurity issues faced by those with data protection...more

28 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide