Main benefits of outsourcing "Exploitant" status : Reminder : French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization. Immediate activation of French Affiliate…
An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing a French Early Access Program for its orphan drug. PharmaBlue support them for the whole process of submission (advice, writing…
Thanks to early access programs, drugs are on average available in France 200 days before their first regulatory approval (FDA or EMA). In this context, early access programs can be extremely attractive for pharmaceutical companies developing life - transforming therapies.…
Known as Expanded Access Programs in the US, early access programs (EAP) allow access to medicines for certain patients before marketing authorization. The French early access program, authorization for temporary usage or temporary authorization (“autorisation temporaire d’utilisation” - ATU),…
Our experts at BlueReg are covering the Early Access Programs specific to France (ATU), and how to take advantage of it. The different subjects discussed in the webinar are : Why Early Access (ATU) for new innovative drugs in France…