Announcement of experienced PharmaLex leadership for BlueReg ensures strength and stability for the business amid ongoing integration Frankfurt, Germany – 14 November 2022: PharmaLex Group, a leading provider of specialized services for the Pharma, Biotech and Medtech industries worldwide, has appointed experienced PharmaLex leader…
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…
Advanced Therapy Medicinal Products (ATMP) are promises medicines for untreatable and high burden diseases where conventional approaches are inadequate such as cancer, cardiovascular diseases, musculoskeletal conditions, or immune system disorders1. To allow patients timely access to these new therapies a…
Background: In February 2022, the EMA initiated the establishment of the Coordination Centre for the Data Analysis and Real-World Interrogation network (DARWIN EU®). In this context, EMA has organised a multi-stakeholder information webinar to: introduce DARWIN EU and…
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),…