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Research and Development Risk Management Regulatory Requirements

Gardner Law

Why Compliance Audits Are Non-Negotiable

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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

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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

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

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] 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

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