Working with CarthaGenetics on your EAP/NPS
Implementation and management of your EAP requires significant knowledge, experience and resources. Your company may not have all the specific experience in this highly regulated environment nor the dedicated resources.
CarthaGenetics® is your partner of choice in setting up your EAP with local people who have broad experience, personal relationships with KOLs, good connections with local health authorities, scientific societies as well as patient groups and KOLS.
CarthaGenetics® approach is always ethical and we are dedicated to help suffering patients. EAP requires managing small quantities in a number of different European markets. This approach is different from traditional marketing methods (like detailing and informing physicians via traditional sales calls or mailings), which would be both inappropriate and prohibited by law, as non-registred products can not benefit from active promotion, whatever the country.
♦ CarthaGenetics® works by identifying the key opinion leaders at the country level and creating reference centers / working with existing reference centers. These national champions will help you to back-up the urgent need for an early treatment access as well as to push and negotiate with the countries’ health authorities.
♦ Setting up an EAP requires a lot of paperwork like individual applications, renewals of those orders, compliance follow-up. Physicians and pharmacists have to build and follow-up with individual patient applications: Carthagenetics people are trained to give support locally.
♦ CarthaGenetics® will help with all distribution activities, including set-up of direct delivery, where possible, training of caregivers, pharmacists and patients, complaint handling and adverse event reports to your pharmacovigilance.
CarthaGenetics® has the expertise, experience, SOPs in place that will provide absolute peace-of-mind that the program is devised and managed effectively and within local regulatory guidelines. With our proven success track, your EA program will be robustly implemented taking into consideration national regulatory nuances.
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