3rd DIA Health Technology Assessment (HTA) Forum – Regulatory and HTA Interface Developments

Venue: NH Barbizon Palace

Location: Amsterdam, Select state..., Netherlands

Event Date/Time: Jun 02, 2012 End Date/Time: Sep 14, 2012
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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.

Featured Topics
• State of play regarding "value" discussions
• Evolution of HTA Regulatory interactions and impact on drug development
• Convergence initiatives to streamline processes
• Progressive licensing and real world evidence generation
• Where do we go from here?

Who Should Attend
Professionals working in:
• Pharmacoepidemiology / Market Access/ Outcomes Research / Managed Healthcare
• Public Policy / Law
• Regulatory Affairs / Policy
• Clinical Research and Development
• Research and Development / Strategic Issues
• Government Affairs
• Pricing and Reimbursement

Learning Objectives
• Hear first-hand from government authorities, HTA institutions, pricing and reimbursement authorities on the latest status of elements that will impact different stages of the drug development and review process
• Be part of developing input to the emerging policy landscape and increase understanding of how best to build interactions inside your organisation to navigate it effectively
• Address regulatory requirements, including pharmacovigilance, paediatrics, scientific and operational challenges
• Get to grips with smart clinical trial design – building in the requirements of all stakeholders in the development and access chain for effective evidence generation
• Exchange experience and best practice to date on innovative approaches to patient access
• Discuss visions for the future of the pharmaceutical and healthcare sectors on a European and, increasingly, international level.