ROTTERDAM, NETHERLANDS @ A panel of experts at RAPS@ European Digital Technology and Software Conference on Thursday urged regulatory professionals to embrace artificial intelligence (AI). They said ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen@s bone cancer drug Xgeva (denosumab), the first drug submitted through the international recognition procedure ...
The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline ...
Discover how to prepare for the UK's new clinical trial transparency requirements coming into force on 28 April 2026. Expert speakers will cover registration, results publication, deferrals, and ...
The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for existing drug and biologics dossiers to the common technical document ...
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.
The Drug Regulatory Authority of Pakistan (DRAP) has published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally manufactured biological ...
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A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
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