How To Win Over The EU CHMP At Virtual Meetings
The Pandemic Has Made Oral Explanations Trickier To Navigate
Speakers at a recent RAPS meeting explained how companies should go about preparing for remote oral explanation meetings at the EMA, and why hybrid meetings with a mix of face-to-face and virtual presentations are likely to become the norm.
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The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.
The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.
While the UK and other countries are implementing or considering additional vaccination campaigns, questions have been raised about the impact on lower-income countries, and COVAX has called on donors and manufactures to honor their vaccine supply commitments.