One of the big draws of attending RAPS’ annual Regulatory Convergence is the opportunity to hear directly from regulators. Each year, the Convergence features dozens of speakers and panelists representing global regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China Food and Drug Administration and many others.

Among the highlights of last year’s Convergence in Baltimore was the opportunity to hear a keynote address  from then-Acting FDA Commissioner Stephen Ostroff.

Ostroff began his remarks by calling the Regulatory Convergence the “perfect venue” for him to speak. “I feel like I’m speaking to my people,” he said. During the course of his presentation, he commented on ongoing changes at the agency, the “uncharted territory” of pending major regulatory legislation and user fee negotiations going on in the midst of a presidential election cycle, and he defended the agency against criticism that it stifles innovation. He also quoted Yogi Berra and Albert Einstein, and was well-received by attendees. You can view his full speech below or on YouTube.

To find out more about the speakers and agenda for this year’s Convergence in San Jose, CA, 17–20 September, visit RAPS.org/Convergence.

Related Articles: