Real-world evidence in advertising CONTEXT: A very interesting opinion piece on the implications of the increased role of real-world evidence (RWE) in the pharmaceutical industry. The article lays out the Continue Reading
Implications of the upcoming changes to French ATU (Autorisation Temporaire d’Utilisation) programme CONTEXT: From July of 2021manufacturers will be required to make all early access authorisation requests to the HAS Continue Reading
CONTEXT: A teaser article for the DIA 2021 where discussions are expected around decentralised trials and accelerated approval pathways. The DIA has always a great place for the industry to Continue Reading
CONTEXT: EMA and DG SANTE have signed a confidentiality agreement with ANVISA | Announcement of a new partnership between EU and Brazilian Regulatory Authorities to further develop mutual recognition and Continue Reading
Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading
Quick Notes: *Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is Continue Reading
