Early approval of medicines (in the EU): levels of knowledge, uncertainties and risks


Geneesmiddelregulering

Understand differences in levels of knowledge, uncertainties and risks at approval for medicines that receive early vs. regular approval; to assess the added value of data requested by regulators to resolve uncertainties in the post-approval phase and to determine the possible consequences of accepted uncertainties and risks.


2016

2020

Utrecht

Lourens Bloem

Aukje Mantel
Olaf Klungel

Jarno Hoekman
Menno vd Elst