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MHRA Chief Executive to step down

European Pharmaceutical Review

While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.

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VarmX to present new data at the ISTH Congress

PharmaTimes

Preclinical data package details pharmacology and safety of VMX-C001

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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

1 These substances “are pharmacologically and biologically active at low doses,” Dr Kishore Hotha, Global Head of Analytical Research & Development at Veranova, explained. ” Highly potent APIs are pharmacologically and biologically active compounds at low doses. What training is required for employees to handle HPAPIs safely?

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Achieving pharmaceutical drug traceability compliance

European Pharmaceutical Review

Key attributes of an enterprise resource planning (ERP) system required for drug traceability has been published in a Universal Journal of Pharmacy and Pharmacology paper. Specifically, it described how ERP systems clarify every aspect of operations in a business for drug serialisation compliance.

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Increasing efficacy in extractables and leachable testing

European Pharmaceutical Review

A paper published in Regulatory Toxicology and Pharmacology has proposed a consistent, health protective read-across methodology for extractables and leachables (E&Ls). The Extractables Leachables Safety Information Exchange (ELSIE) ’s safety team developed the methodology for generating permitted daily exposures (PDEs) for E&Ls.

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Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval

Pharmaceutical Technology

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. Brexpiprazole was found to be well-tolerated and its safety profile was consistent with its known safety profile in other indications.

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Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022

pharmaphorum

The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.