Former FDA Acting Commissioner and other industry experts to offer insight on turning Risk Evaluation and Mitigation Strategies theory into practice.
Princeton, NJ-May 9, 2008-Covance, the world’s largest publicly traded contract research organization, will gather experts from government, pharmaceutical, and legal communities to discuss the impact of Risk Evaluation and Mitigation Strategies (REMS) on drug approvals, healthcare providers, patients, and patient safety on May 29, 2008, from 10:00am–4:30pm at the Marriott Hotel and Conference Center in Princeton, NJ.
Dr. Lester Crawford, former acting commissioner of the Food and Drug Administration (FDA), will be the keynote speaker at the complimentary symposium designed for pharmaceutical and biotechnology executives in risk management, safety, regulatory affairs, and medical affairs. Panelists also include pharmaceutical, legal and scientific experts specializing in areas ranging from drug approvals, post-market commitments, risk management, and REMS as they relate to the Food and Drug Administration Amendments Act (FDAAA) of 2007.
“This event will help provide pharmaceutical and biotechnology executives with practical solutions for applying REMS to their drug development programs,” said Hani Zaki, general manager, periapproval services, Covance. “Our goal is to provide education, interpretation, and application of REMS to help attendees prepare for any anticipated implications on drug approvals, patient selection, and safety.”
FDAAA has been called the most sweeping reform of drug legislation in decades, and for the first time grants the FDA authority to enforce post-marketing agreements through fines and other forms of regulatory controls. The FDA may now also require new post-marketing study commitments (PMCs) or demand other risk-mitigation steps at any point post-approval should new safety signals emerge.
Pharmaceutical and biotechnology executives involved in risk management, safety, regulatory affairs, and medical affairs can register for the complimentary symposium via e-mail at email@example.com.