Value and Access
This track explores the various aspects relating to the implementation of European Regulatory Network Strategy, the EMA Regulatory Science Strategy, European Commission Pharmaceutical Strategy and the interface with the global regulatory advancements. It looks at novel therapies coming to the market with unprecedented speed, unmet medical need, patient centricity, building further capabilities in regulatory science, ongoing developments in biosimilars, medical devices and drug device combination, development support and the future of evidence as it relates to regulatory approvals. We will also look at how the regulatory framework in Europe will transform and focus on the balance between adaptability and sustainability, medicine access, manufacturing innovation and solutions for drug shortages.
Who is This Track Designed For?
Professionals involved in regulatory strategy, regulatory policy and intelligence, market access and HTA policy, project management, patients, academics and consultants
The online program is now available. Explore the rich content we offer across 10 thought leadership tracks.
Nadege Le Roux, DrPH, PhD
Regulatory Affairs Senior Director
BRISTOL-MYERS SQUIBB, Switzerland
Division of Pharmacoepidemiology and Clinical Pharmacology
Utrecht University, Netherlands
Founder & CEO
Akceso Advisors AG, Switzerland
Innovation Without Access Will Never Meet Patient Needs
Innovations in therapeutic product development will only be effective when patients can access and use them. But establishing and explaining the value and price of these innovations among so much unmet need, and ensuring access by patients who need them, has proven difficult throughout Europe and elsewhere. “Policymakers more often or too often have a short-term view, short-term perspective, rather than a long-term perspective, and sometimes are driven more by political goals than promoting patient access in a real way,” suggests Andras Incze, Akceso Advisors. “We want the breakthrough innovations to reach patients throughout Europe. We want the best products and to get them to patients as fast as possible,” explains Rick Vreman, Utrecht University, the Netherlands. “But then it gets a bit more tricky when we start to think about what we need to make that happen.”
Day 1: Tuesday, March 29th
Identifying and Managing Uncertainty During Drug Development to Improve Predictability of Regulatory and HTA Outcomes
Valuing the Value of Gene Therapies: Evidence Underlying regulatory and HTA Decision-making for Advanced Therapies: Trends, Challenges and Learnings
Day 2: Wednesday, March 30th
Impact of Price Transparency for Patient Access: Its Pros and Cons, Over Short- and Long-Term
Innovation Systems in Europe: Beyond Radical or Incremental Only
Expedited Pathways – Do we need a Modernization in Europe?
Day 3: Thursday, March 31st
HTAi Group: the More the Merrier: Aligning Regulatory Decision-Making and Health Technology Assessment When Managing Uncertainty
DIA Europe 2022 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.