Increasingly, payers and physicians are seeking real-world data on newly approved medications. Post-Authorisation Safety Studies (PASS) can provide this vital safety information and encourage market acceptance and uptake.
The new Disclosure Code from the European Federation of Pharmaceutical Industries and Associations (EFPIA) requires reporting of transfers of value to healthcare professionals (HCP) and healthcare organisations (HCO.) Our latest blog post reviews critical dates related to the code and highlights the similarities and differences between this regulation and the U.S. Sunshine Act.
You’ve heard it a thousand times in our business: You’re not buying the service, you’re buying the people. I was fortunate enough to build our clinical team in Europe from the ground up, so I know better than anyone how true that statement is.
When I joined the organisation in 2008, I was the first European-based employee for UBC. I rented offices in a three-story, converted Victorian house in central London, which we still fondly refer to as the “old house,” and started seeking talented professionals to join me.
The centralised procedure, which came into operation in 1995, allows applicants to pursue a marketing authorisation that is valid throughout the EU. The European Medicines Agency (EMA) can take up to 210 days to review these new product applications and the agency has an additional 15 days to submit its opinion to the Commission.
Manufacturers waiting for the EMA’s opinion may feel like time is standing still. Ensuring safety and regulatory documentation is properly prepared and consistent helps keep the review process moving.