companies to consider and navigate in running Early Access Programmes.
Ahead of this year's conference, Pharma IQ spoke to Arthur Caplan, Head of Bioethics, New York University Langone Medical Center and Chairman, of the Compassionate Use Advisory Committee on the subject of running successful Early Access Programmes amidst the challenging ethical climate.
This Pharma IQ handbook showcases the main regulatory requirements to be considered in regards to early access programmes within the EU. Including specific requirements for Austria, Denmark, France, Germany, Italy, Spain, Sweden, Switzerland, and the UK.
In this Pharma IQ interview, Jose Ricardo Perez, Senior Medical Director at Novartis,highlights the biggest considerations for someone potentially looking at a new early access programme (EAP) and the key regulatory differences between the USA and Europe. Perez also reveals his top tips for someone looking to implement an early access programme.
Five minutes with Vee Mapunde on: the growing influence of patient advocacy groups in Early Access Programmes
We had a chat with Vee Mapunde, Associate Consumer Lead at the National Cancer Research Institute (NCRI) on the role of patient advocacy groups in the Early Access Prorammes landscape, their missions and the tools they have to fulfill them, ahead of the Early and Managed Access Programmes conference (24th-26th October 20170. The power is now shifting towards the patients, so what impact does this have on patient advocacy groups?
Early and Managed Access Programmes can prolong the life of patients who have a life-threatening illness or a chronic or rare condition, by providing them access to investigational drugs. Their investigative nature does mean that ethical challenges often arise during their process. Ahead of the third annual Early and Managed Access Programmes Forum (24-26th October, 2017), we have worked with industry and compiled three 'top tips' to ensure an ethical and sustainable Early Access Programme.