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Data Management Regulatory Agencies

Husch Blackwell LLP

Clinical Trial Audit Readiness: A Step-by-Step Guide for Research Sites

Husch Blackwell LLP on

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more

Pagefreezer

Expert Advice: New Study Reveals Top 3 ESI & Litigation Readiness Challenges

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Did you know that nearly 1/3 of companies have been fined by courts or regulatory agencies because the organization couldn’t respond in time to requests for electronically stored information (ESI)?...more

Jenner & Block

California Privacy Protection Agency Invites Comments on Proposed Rulemaking; Appoints First Executive Director

Jenner & Block on

The new California Privacy Protection Agency (“CPPA”) has made two recent notable announcements. On September 22, 2021, CPPA issued an Invitation for Preliminary Comments on Proposed Rulemaking Under the California Privacy...more

Hogan Lovells

FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

Hogan Lovells on

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that...more

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