Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants, Online, 13:00 - 17:00 Amsterdam time

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The workshop is organised to bring together scientists, clinicians, industry representatives and regulators to discuss alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. The current evidence for the use of surrogates of clinical efficacy to support the activity of already approved/authorised monoclonals and the development of novel monoclonal antibodies against variants of concern will be discussed.

A full agenda will be available before the meeting.

Please note that there will be no other meeting materials.

Sumber : https://www.ema.europa.eu
 
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