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

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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.”