Multimedia
September 29, 2022
Regulatory Strategy for Registering Rare Disease Products in the EU
In this webinar we will focus on how to benefit, today and in the future, from the orphan drug program and build a regulatory strategy for successful rare disease product registration(...)
Drug Development
Rare Disease
Regulatory
Publications
August 4, 2022
White Paper: New European Health Technology Assessment Regulation
In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.
MedTech
Regulatory
Publications
July 14, 2022
How to successfully use the EMA IRIS portal to ensure timely submissions
Submitting your scientific advice (SA), orphan drug designation (ODD) or Innovation Task Force (ITF) consultation to the EMA? Avoid delays with our submission recommendations.
European Medicines Agency
Orphan Drug
Regulatory
