ePT--the Electronic Newsletter of Pharmaceutical Technology
The Parenteral Drug Association (PDA, Bethesda, MD) finished the second stage of GMP training for representatives from the Republic of Kazakhstan?s Ministry of Health.
The Parenteral Drug Association (PDA, Bethesda, MD, www.pda.org) finishedthe second stage of GMP training for representatives from the Republicof Kazakhstan's Ministry of Health. Over the next three years, PDAplans to train 100 delegates from Kazakhstan in an effort "to develop astronger, more informed pharmaceutical regulatory agency," PDA said inan official press release.
The training focuses on US and European regulations and requirementsnecessary for the review and approval of drugs and biologic products.Sessions also cover a range of drug development topics includingclinical trials, manufacturing, labeling, and advertising.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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.
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.