Solve The Challenges Of Launching And Maintaining Early And Managed Access Programmes, Navigate The Complex Regulatory Landscape And Hear The Patient’s Voice!
Join us 22nd - 24th October 2018, where industry leaders from Janssen, Novartis, Alexion and Bionical will discuss their EMAP strategies with solicited input from Patient Advocacy Groups and Regulatory Professionals from across Europe and the US.
Download the 2018 agenda for a look at who is speaking and the topics to be discussed!
Download the 2018 agenda for full speaker and session information!
Pharma IQ spoke exclusively to Martin Naley, US General Manager and Global Head of Business Development at myTomorrows about the challenges of increasing patient access to therapies through early access programmes. We also discussed the work that myTomrorows is doing to assist patient access through real world therapeutic testing and the key elements in building a framework for expanded access.
One of the key benefits of Early Access Programmes is that they allow companies to collect real world data from patients within the programme, which can help inform a product’s effectiveness and value proposition.
With insights from Tom Watson, Executive Vice President, Early Access Programmes, Bionical, in this article you will learn:
- The benefits of gathering RWD during the testing phase
- The preferred methods for RWD collection in patients with rare conditions
- The insights that RWD can provide to support expanded indication
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
Download now to view the sample attendee list for EAP's 2016.
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.
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.