Regulatory Roundup: ICH to Hold Training Workshops for Quality Guidelines
ePT--the Electronic Newsletter of Pharmaceutical Technology
ICH to Hold Training Workshops for Quality Guidelines
The International Conference on Harmonization’s Implementation Working Group (IWG) for the quality guidelines, Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, is holding a series of training workshops. The US workshop is being held in Bethesda, Maryland, Oct. 6–8, 2010. The International Society for Pharmaceutical Engineering (ISPE) and Parenteral Drug Association (PDA) are sponsoring the workshop, which is meant to help industry understand how the quality trio can benefit pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operations, and GMP inspection. Regulators from various countries and regions will be presenting at the meeting. Four breakout discussions will address design space, control strategy, the pharmaceutical quality system, and quality risk management. Feedback from workshop participants will help IWG with harmonization efforts.
FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy
March 25th 2025Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.
