Remove 2024 Remove Animal Testing Remove Compliance
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Time for change: non-human primates in drug research

Drug Target Review

2 This ethical spotlight has practical implications for research institutions and sponsors, including the need for more robust justification protocols, heightened compliance measures and increased risk of reputational harm or funding loss. NIH Office of Laboratory Animal Welfare – Training Guidelines. Ncardia, 2024.

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Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

between 2024 and 2030. One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. billion in 2023 and is expected to grow at a CAGR of 7.0%

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Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

BY SCOTT STEPHENS, MPA | MAR 7, 2024 8:21 AM CST The format: an emphasis on conversations ECHA’s one-day event , titled “Shaping Tomorrow,” was held at the agency’s headquarters in Helsinki, Finland and live-streamed on ECHA’s website. Among the topics: stakeholder cooperation in the context of the green and digital transition.

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Finally, MDCG 2024-3 outlines the expected content for a clinical investigation plan and MDCG 2024-5 describes the content of the investigator’s brochure.

Trials 40
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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

BY RAYAN BHARGAVA, MSC | JAN 11, 2024 6:55 PM CST Regulatory background A 2019 fitness check of the most relevant chemical regulations found that protection afforded to human health and the environment was of a suitably high standard, although issues with consistency and efficiency were evident.

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Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Agency IQ

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.