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 two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.
EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.