WHO joins agencies in beefing up inspections of API facilities

The World Health Organization (WHO) is joining an effort to extend the reach of regulatory inspections of API facilities and reduce duplication by sharing resources, InPharm reports. The effort was started by the US, Europe and Australia, allowing each to rely on inspections by the others to better use existing resources. The FDA, EMA and the Australian Therapeutic Goods Administration (TGA) can accept a report, ask regulators of one of the participants to expand an inspection or they can hold joint inspections. A recent report on the effort noted the WHO has joined through its Prequalification of Medicines program and that other entities agreeing to the requirements also may be allowed to participate. Story | Report


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.