Pharmacovigilance and Risk Management Strategies 2016

Patients need faster access to innovative, effective and safe medicines, especially in cases where there are no adequate treatments available. In 2012, the US Food and Drug Administration (FDA) introduced a new regulatory pathway called Breakthrough Therapy Designation, which aims to accelerate the development and review of drugs to treat serious or life-threatening conditions. The European Medicines Agency’s (EMA) Adaptive Pathways pilot is part of efforts to get patients suffering from serious conditions with an unmet medical need faster access to new drugs. Meanwhile, other regulators around the world are also exploring the adaptive licensing model (e.g. Singapore’s HSA, Health Canada). One critical question in accelerating the approval process is how much safety data is needed before breakthrough therapies can be approved. This session will explore this issue from multiple perspectives in a Q&A panel discussion format. Submit your questions for the panel at the DIA registration desk.