Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
2020 is when supply chain partners must agree on a vision for the track-and-trace anticounterfeiting system due in November 2023, experts tell the Pink Sheet.
US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.
Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.
Launching desktop assessments to ease the inspectional workload of regulators and forging stronger relationships with India and China are two key priorities for the international inspectorate group this year.
Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.
Despite some previous uncertainty about sufficient funding commitments from members, the coalition of manufacturers, wholesalers and distributors is operational, with a meeting planned for early next year. It will oversee data governance systems for implementing the US supply chain safety law, a key element of the law's third phase set to go into effect November 2023.