The HTA Regulatory environment has evolved significantly in recent years. New structures, new collaborations and new legal frameworks will see an increased level of interaction between countries, but also between different stakeholders in the process of bringing new therapies to patients.
In particular, collaboration between HTA organisations and HTA and regulatory authorities has accelerated at a rapid pace. This has been driven by a number of factors, in particular a recognition that HTA decision makers need to harmonise requirements for drug developers in order to support efficient drug development, as well as by a desire by regulators to ensure their decisions have greater relevance in the real world. HTA organisations in Europe are increasingly cooperating through bodies such as the European Network of Health Technology Assessment (EUnetHTA) and are piloting new processes that have the potential to significantly impact access for new medicines. Over the last 5 years, HTA organisations have started to offer early advice procedures and more recently, regulatory bodies have begun to collaborate with HTA agencies to offer joint advice procedures at both a national and an international level.
How will the different players involved interact in future and how can they best cooperate to develop systems that stimulate and reward innovation, safeguard patient safety and ensure timely access to novel therapies? How will the ongoing development of structured dialogue between HTA and Regulatory Agencies during medicine development ensure the inclusion of all stakeholders needs within a single integrated development programme? Will such collaborations lead to simplification of drug development requirements and ultimate alignment of pre and post-regulatory approval requirements?
Join us at this year’s DIA Health Technology Assessment Forum where these questions and many more will be addressed. The 2012 event builds on the discussions at two previous DIA meetings and aims to take the debate to the next level – contributing to the policy developments in the field over coming years, leveraging DIA’s unique role in bringing together regulators, government authorities, EU institutions, patients and industry into one forum.