Examining the regulatory differences between the European and US Pre-Approval Access Routes

Examining the regulatory differences between the European and US Pre-Approval Access Routes

mercredi 4 novembre 2020 09:10 à 09:40 · 30 min (Africa/Abidjan)
Access & Pricing

Informations

Early Access to Medicines Programs (EAMs) in Europe provide pre-launch, pre-Market Authorisation, Unlicensed Medicines, pre-commercialisation, and Named Patient Programs access to drugs and treatments for patients with life-threatening conditions and no approved treatment options. EAM programs can be both product and country specific, are based on what you can negotiate, should not be cookie cutter, and are able to provide valuable information and in some cases limited financial returns. Increasingly, EAMs provide opportunities for early stakeholder engagement, RWE, clinical adoption support and in some cases, could foster swift patient access to breakthrough medical products
Caligor Coghlan Pharma ServicesAt Caligor Coghlan Pharma Services (CCPS) our Early Access to Medicines (EAM) services are designed with one goal in mind: to expand access to treatment so more people benefit from the impact of innovative medicines. Our EAM team has a background in the clinical trial world and each of or our team members have been part of global orphan and rare disease drug development and global clinical trials. These skills have been transferred over to the unique world of “Early Access to Treatments”. We have the skills and experience to design, set up and manage these unique programs around the world, providing both the client and physicians with expert support throughout the process. In addition, our Regulatory Affairs and Strategic Services group can assist you with a range of services supporting drug and device development from concept to commercialization.

Connectez-vous