"In this session, senior staff from the U.S. FDA and the European Medicines Agency (EMEA) will present key regional regulatory initiatives, as well as FDA-EMEA collaborations. Topics may include, for example, joint briefings on voluntary genomic data submissions, mechanisms for parallel scientific advice and accelerated approvals and international harmonization of regulatory requirements."

Objective1:Outline key FDA and EMEA organizational and policy initiatives.

Objective2:Discuss FDA-EMEA collaborations.

Objective3:Stimulate interactive discussion among FDA, EMEA and attendees with respect to the initiatives and issues presented.