Regulatory Roundup: Presentations Available from ICH Quality Workshops.
ePT--the Electronic Newsletter of Pharmaceutical Technology
Presentations Available from ICH Quality Workshops
The presentations from the ICH quality-trio workshop series, held in Bethesda, Maryland, Oct. 6–8, are now available on the ISPE website. The workshop featured members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and focused on design space, control strategy, quality systems, and risk management. Also on the website is a downloadable copy of the case study used in the workshop. The case study uses a fictional active pharmaceutical ingredient (API) to describe how to implement quality-based approaches to develop pharmaceutical manufacturing processes.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
