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
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
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 2017. 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.