OVERVIEW Within the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) assesses the applicant’s quality, safety and efficacy data deciding on whether to recommend marketing authorization to the EMA. 31 members: One representative from each EU member nation (28 voting members), plus 3 non-voting members…
In our last blog, we focused on the non-transparent nature of CHMP meetings – and the challenges sponsors face in making sure that CHMP representatives understand and retain the presenters’ messages.
In this follow up article, we detail how to succeed given an often limited preparation timeline. It requires five key considerations.
The first thing you need to know about CHMP meetings is that they are not public.
Because of this, you can’t research the meeting by watching a video online or reading a transcript. At the same time, these are extremely high-stakes meetings, where companies present their data and answer questions before a panel of individuals who will likely decide – or at least heavily influence – the future of the company’s product.