Plenary Sessions

Monday, 12 November
08.30 – 12.00

Nancy Berg

Nancy Berg will welcome the delegates to San Francisco and discuss how ISPE is leading members and industry in finding solutions to technical and regulatory complexities in today’s business environment. Driven by an expanded mission reflective of the entire pharmaceutical lifecycle, ISPE is stimulating discussions on relevant issues--collaborating with members, companies, regulators and other associations in their quest to help companies enhance product quality and improve patient safety.

Charlotte Enghave Fruergaard, Ph.D.

Dr. Enghave Fruergaard will discuss the important role of ISPE members in driving change and technological innovation. As 2013 Chair of the ISPE International Board of Directors, some of her top priorities include simulating ISPE’s culture to reflect its diverse, global membership and engaging young professionals in the society’s programs and initiatives.

Murray Aitken, Executive Director, IMS Institute for Healthcare Informatics

Top Priorities and Trends for the Pharmaceutical Industry

IMS Institute for Healthcare Informatics provides policy setters and decision makers in the global health sector with objective, transformational insights into healthcare dynamics derived from granular analysis of information.

Hear cutting-edge research in the pharmaceutical market and learn how to address those changes and what your company should be focusing on next. IMS will release quantifiable data which will provide a global analysis of the industry as well as forecasting top priorities and trends through 2016. Exclusive information will also be released to Annual Meeting attendees only.

Stephen P. Spielberg, M.D., Ph.D.

How the FDA is Advancing Regulatory Science through High Quality Collaboration

When Commissioner Hamburg created the position of Deputy Commissioner for Medical Products and Tobacco, she envisioned that it would “provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products, and support, coordinate and advocate for the work and needs of the Centers.”

This high-level presentation, aimed at showing you how through synergy and alignment, the FDA is addressing challenges and taking advantage of opportunities to advance regulatory science. Don’t miss this opportunity to hear how these new FDA strategic initiatives are impacting you and your company.

FOYA

Learn about the innovative projects from the 2012 Facility of the Year Awards Winners. Find out first hand which one will be named the 2012 Facility of the Year Awards Overall Winner which recognizes state-of-the-art pharmaceutical manufacturing projects utilizing new and innovative technologies to reduce the cost of producing high cost medicines.