Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering. This training is designed for ...

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today ...

Good Clinical Practice (GCP), the bedrock of ethical and high-quality clinical research, guides operations among sponsor companies, contract research organisations (CROs), investigator sites, and ...

The International Council for Harmonisation (ICH) on Friday said it has made “significant progress” on new and existing guidelines following a weeklong meeting in Charlotte, North Carolina earlier ...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") has released a reflection paper on Good Clinical Practice ("GCP") "Renovation," which ...

Analytical characterization is vital for product quality, manufacturing control, and regulatory compliance in biopharmaceutical development. ICH Q6B outlines structural characterization requirements, ...

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best ...

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved. The International Council for Harmonisation’s (ICH) Q9 Quality ...