Join the Early and Managed Access Programmes forum to explore topics in: Preparing for your Early Access Programmes with effective planning and a water-tight logistical strategy, navigating the complex and diverse regulatory and ethical landcape, the debate surrounding Real World Data, optimising your clincal operations and post-trial access.
On the 5-7th November 2019, over three full days of case-studies, interactive discussions and workshops, industry leaders from companies such as Janssen, Bristol-Myer's Squibb, Novartis, Vifor Pharma and Zogenix will discuss their EMAP strategies with input from Patient Advocacy Groups and Regulatory Professionals from across Europe and the US.
Download the 2019 agenda for a look at who is speaking and the topics to be discussed!
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