In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.
The management board of the European Medicines Agency (EMA) meet on December 14–15, 2022 in Amsterdam to discuss recent activities related to the response to COVID-19, including seven vaccines, four adapted vaccines, and eight treatments authorized for use in the European Union.
The meeting went into detail about multiple topics, such as a new budget and updated multiannual programming document for 2023–2025, which looks at looking at the growing workload from COVID-19 and the availability of resources.
In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.
The Committee for Advanced Therapies Report also presented key highlights and achievements of the Committee from 2017-2022 to the Board. The Board took time to acknowledge the work of the Committee in the last 6 years and its continued efforts to support developers through the production of guidance documents and the organization of workshops and training.
Source: European Medicines Agency
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.