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. With this in mind, Pharma IQ have worked with industry and compiled three 'top tips' to ensure an ethical and sustainable Early Access Programme.
Katalin Kovacs' presentation from the Early and Managed Access Forum 2017 delves into the regulatory complexity of access within EU Law. Find out about the criteria for specific regulations such as Art. 5 (1) -Directive 2001/83EC) and Art. 83 of Regulation (EC) No 726/2004, and how these are used.
Embarking on an Early Access Programme is challenging due to a number of factors, including navigating the complex regulatory landscape and the modality of providing access to patients. Ahead of her participation in the upcoming Early and Managed Access Programmes Forum, we spoke exclusively to Allison Morgan, Managing Director, Metis Clinical to discuss the key considerations that need to be taken prior to initiating an early access programme.
This article will discuss: defining the nature of supply, considering the stage of drug development, anticipating for demand, planning for data capture restrictions and ethical considerations