The international pharmaceutical supply-chain consortium Rx-360 has launched in Europe; with more than 135 industry and regulatory representatives attending to discuss the global impact of counterfeit drug products.
The international pharmaceutical supply-chain consortium Rx-360 has launched in Europe; with more than 135 industry and regulatory representatives attending to discuss the global impact of counterfeit drug products. Attendees also focused on the challenges involved in creating a nonprofit, voluntary consortium that will focus on shared supplier audits and disseminating supply-chain information and standards throughout the world.
The consortium held a US-launch meeting for pharmaceutical and biotechnology companies, suppliers, and regulators in June 2009 in Washington, DC (USA).
Another European-based initiative from the growing consortium is its new homepage widget, which features a searchable database of suppliers that have been certified by the European Directorate for the Quality of Medicines and Healthcare (EDQM). Established in 1994, the EDQM program specifically certifies the suitability of the monographs in the European Pharmacopeia to adequately control the quality of a substance from the source.
Pharmaceutical Technology spoke to the director of EDQM, Susanne Keitel, and the head of Rx-360, Martin Van Trieste, among others, as part of a unique roundtable earlier this year. The speakers’ full talks are available as a podcast.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
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.