Posted by Michael Wonder on 27 May 2020
Prospective dialogue between developers and regulators makes for better evidence generation
27 May 2020 - EMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of early interactions as an opportunity to improve the generation of evidence required for bringing innovation to patients.
An article, published in the British Journal of Clinical Pharmacology, analyses the importance of early advice for the generation of robust evidence after authorisation, once a medicine is used in clinical practice.
Post-licensing evidence is often requested by European regulators following the approval of a medicine, to complement the understanding of a medicinal product's benefit–risk profile.
