DIA EuroMeeting Focuses on the True Benefits of Innovation
Key thought leaders across stakeholder groups come together at the EuroMeeting to exchange opinions, learn from one another and establish the best path forward in delivering positive outcomes for patients. With representation from 15+ regulatory authorities, including the European Medicines Agency (EMA), The European Commission and Japan Pharmaceuticals and Medical Devices Agency (PMDA), the forum provides a unique opportunity to hear directly from the regulators on the future of pharmaceutical and medical devices development.
This year’s programme chairs set the stage for the DIA EuroMeeting forum collaboration across industry, regulatory agencies, academia and patients.
“We do not have many platforms available to bring people together from industry, academia, and regulatory agencies,” said Karl Broich, President of BfArM and one of the EuroMeeting 2016 programme chairs. “The importance of DIA is that all these groups have an opportunity to exchange on these ideas in an informal way and to get new ideas, new proposals and new ways of how to do drug development.”
According to Kemal Malik, Member of the Board of Management for Bayer and fellow EuroMeeting 2016 programme co-chair, “DIA provides a safe harbor forum where we, from the industry, can talk to people from regulatory authorities about issues that are common to us without the normal setting of a project. It’s a very unique forum and one that should be cherished.”
The conference will be held 6 – 8 April, 2016 in the Congress Center Hamburg, Germany and is open to registrants across all areas of pharmaceutical and medical device development.
Several sessions of note include:
Benefit-Risk Management Planning through the Life Cycle of a Product
Joint Session: 0101/0701/0901/1301: 7 April, 9:00 – 10:30
Multiple scientific and policy initiatives have the potential to change the landscape for drug discovery, development, regulation, and reimbursement. The session will present some highlights, with a particular focus on optimising drug development, real-world and ‘big’ data, and multi-stakeholder dialogue, to inform prospective planning for evidence generation across the drug life cycle.
Gene Therapy – A New Treatment Modality: Opportunities and Challenges from a Patient’s, Industry, Regulatory and Payer’s Perspective
Session 0102: 7 April, 11:00 – 12:30
Modifying cellular gene expression to treat diseases has been a long-term goal which, due to novel technologies, now seems to be reachable. The panel will discuss emerging opportunities and hurdles that need to be overcome to make this dream a reality.
The Future of Regulatory Affairs is Digital – Key Success Factors for Regulatory Affairs in a Rapidly Changing Environment
Session 0403: 7 April, 14:00 – 15:30
The “EU Telematics Strategy” describes a set of initiatives and goals which influence the business processes and techniques in our business. Nearly all processes are concerned by the implementation. New opportunities appear and challenges have to be mastered on the way to the digital future. This session will present an overview how NCAs (national competent authorities) and industry prepare.
New Approaches to the Approval of Innovative Medicines: Do They Keep Their Promise?
Session 1002: 8 April, 11:00 – 12:30
EMA, FDA and PMDA have introduced or are planning to introduce facilitated regulatory pathways aimed at encouraging the development and authorisation of innovative medicines. This session will provide information on these approaches, compare their characteristics and look into their benefits for patients and for industry.
Oxford Debate: ‘This House Believes that Over-Engineered Clinical Development Has Inhibited Innovation’
Joint Session: 0206 / 0306: 8 April, 11:00 – 12:30
High-profile representatives from academia, industry, and patient organisations will debate both sides of this controversial hypothesis. Debaters will explore and argue the impact of regulations, budgets, quality, and patient needs.