Representatives from FDA and EMEA to Present on Pediatric Regulations and Risk Management Plans
London, UK (April 24, 2007) Carlos Langezaal, director, Regulatory Development - Neuroscience, Sanofi-Aventis, Bridgewater, New Jersey and Head of TOPRA North America, today announced that TOPRA has confirmed participation of multiple regulatory authorities in the 2nd TOPRA North America Symposium to be held on Wednesday, May 2, 2007 at the Westin Grand Hotel in Washington, DC. Speakers for the Symposium include representatives from the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).
The agenda for the symposium has been divided into two sections to focus discussions on two critical industry topics: pediatric regulations and risk management plans. These topics have attracted the interest of multiple global regulators who will participate in the presentations and panel discussions with industry peers.
"Pediatric regulations can be complex and overwhelming and experience in the development of risk management plans is becoming essential when navigating the global regulatory landscape", noted Chris Griffett, executive director, Global Regulatory Affairs, Schering Plough and TOPRA North America Membership Committee. "It is important that Regulatory professionals understand the nuances of each and participate in dialogs with their agency and industry peers to prepare their organizations for success.
"The topics for the Symposium were selected because of their applicability to global organizations and their priority in the global regulatory landscape. "These topics are not trivial and warrant continued thought and analysis", noted Carlos Langezaal, Head of TOPRA North America. "The opportunity to discuss pediatric regulations and risk management plans in detail with industry and agency leaders is quite rare. The program is designed so that delegates have the opportunity to learn from peers, ask questions and get practical answers. Regulatory professionals with global responsibilities should consider this an important opportunity that shouldn't be missed."
TOPRA's first North America Symposium was conducted in 2006 with great success and attracted attendees from international organizations in Europe and the United States. TOPRA is the global organization for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Current membership is drawn from over 40 countries worldwide.
TOPRA is a non-profit, non-political organization, which seeks to advance the status of the regulatory profession through education, and provision of information to its members.