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!
With regulations differing between European countries, it’s no easy feat launching an early access programme internationally!
Ahead of the Early and Managed Access Programmes Forum taking place this November in London, Pharma IQ has gathered together key regulatory information you need at your fingertips when launching your programme into different European countries. Download the handbook to learn the key compliance requirements that surround the implementation of an early access programme in each country.
Countries covered include:
- United Kingdom
Managing an Expanded Access Programme can bring many challenges for pharma companies, such as navigating the complex regulatory landscape, logistical planning, ethical concerns and unsolicited requests from increasingly well-informed patients.
Pharma IQ spoke to Gregory Tuyteleers, Global Operations Lead, Managed Access at Janssen, to gain his expert recommendations on "5 Key Steps for Early Managed Access Programmes". In this checklist, Gregory leads us through crucial considerations including:
- The need for a governance body
- Adopting a company-wide approach to early access
- Compliance with regulations from country to country
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