News & Analysis as of

Risk Mitigation Life Sciences

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

Venable LLP

[Ongoing Program] Life Sciences Series - Product Liability Risk Management Strategies in the Pre and Early Litigation Time Frame -...

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

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

[Webinar] Managing Risks Through IP Innovation Management Training - October 4th, 2:00 pm ET

Of Counsel James Hastings will present a webinar titled "Managing Risks through IP Innovation Management Training" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 157: Sarah Glover, Maynard Nexsen Cybersecurity Attorney

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Maynard Nexsen cybersecurity attorney Sarah Glover joins hosts Heather and Lauren to discuss cyber attacks on health care organizations. Sarah shares her perspective on risk factors, how to mitigate risk, and the cost of data...more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

Orrick, Herrington & Sutcliffe LLP

Additional Considerations on IP Due Diligence for Prospective Investors of Emerging Life Sciences Companies

Following our first article on IP due diligence considerations for prospective investors of emerging life sciences companies, we’re taking an in-depth look at the due diligent action items that can help with decision-making...more

White & Case LLP

Strong Medicine: Using Investment Treaties to Mitigate Foreign Regulatory Risk in the Life Sciences

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The COVID-19 pandemic has accelerated the globalization of the life sciences industry, driving cross-border collaborations to develop urgently needed treatments, scale up manufacturing and distribution, and fill raw material...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

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The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

Goodwin

Client Conversation: Square Mile Capital

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As investors’ demand for life sciences real estate grows at a rapid pace, lenders are actively seeking to lend in this space. Goodwin partner Jarrid King spoke with Eric Juster, Vice President, Investments at Square Mile...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

Goodwin

Survival Guide to Structuring Life Sciences Partnering and M+A Agreements

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The life sciences space is ever-growing and dynamic as the industry witnesses more companies and, therefore, more collaboration, licensing and M&A agreements, come into the spotlight. While these deals are exciting...more

McDermott Will & Emery

[Webinar] Regulatory Disputes with HHS: When to Negotiate and When to Litigate - March 25th, 12:00 pm - 1:00 pm EST

McDermott Will & Emery on

For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more

Hogan Lovells

IoT in the EU: Lessons from COVID-19, and next steps for liability and regulation

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The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more

Epstein Becker & Green

[Virtual Briefing] Bias in Artificial Intelligence: Legal Risks and Solutions - March 23rd, 1:00 pm - 4:00 pm ET

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You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more

K2 Integrity

The COVID-19 Vaccine is Here. What Does That Mean for Counterfeiting?

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As the COVID-19 vaccine sees imminent, large scale release in jurisdictions around the world, pharmaceutical manufacturers are faced with the complex challenge of a coordinated global roll out. There is little question that...more

Hogan Lovells

Looking ahead to 2021: AI – A brave new world?

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In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more

American Conference Institute (ACI)

[Virtual Event] 25th Annual Conference on Drug & Medical Device Litigation - December 8th - 9th, 8:45 am - 5:45 pm EST

Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more

Goodwin

Envisioning the New Normal: Real Estate + Technology – Part 3: Life Sciences And Healthcare Industries

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This article is the third in a multi-part series examining the impact of the COVID-19 pandemic on select real estate sectors and the considerations around how technologies will shape future operations and accelerate means to...more

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