Carolyn Hynes
Carolyn Hynes is Senior Director Regulatory Intelligence, Oncology Regulatory Science, Strategy and Excellence, AstraZeneca.
JournalProject Orbis – a sponsor’s perspective on the collaborative international review process
Project Orbis provides a framework for concurrent submission and review of regulatory dossiers with member agencies in the project, and has the goal of providing faster patient access to innovative cancer therapies
Meeting ReportHM2: Fireside chat with Emer Cooke: a review of current and future priorities
This session was a conversation between Daniela Drago and Emer Cooke. Ms Drago began by asking Ms Cooke to reflect on her first ten months leading the European Medicines Agency (EMA). She was quick to respond: “It has been incredible, a privilege”, adding that it is an exciting time for medicines regulation in Europe and, indeed, the world.