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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COVID has demonstrated the importance of regulatory systems that ensure the safety and efficacy of therapeutic products as well as patient access to these products, especially in the complex network of healthcare, scientific, pharmaceutical, regulatory, and patient communities in Europe. “Regulators and industry have worked day and night over the last two years to bring vaccines and therapies forward. We know very clearly that sustainability of the system is an issue. More regulatory resources and simpler processes are desperately needed,” explains Isabelle Stoeckert, Bayer AG vice president and head of regulatory affairs for Europe, Middle East, and Africa. “Many countries have learned that reliance and collaboration between regulators is a really good thing. COVID-19 has really shown that,” suggests Henrik Nielsen, Novo Nordisk vice president of global regulatory sciences. “And I think this will stay, so we will see more reliance between regulatory sources, and we'll probably see increased use of different collaboration schemes around the world.”