As the emphasis on drug development shifts toward improving risk management, new tools have emerged to evaluate safety both pre- and postapproval.
Increasingly, companies are looking at patient registries as an integral part of their safety arsenal…
Postmarket Registry Study Serious Adverse Event Reporting to FDA
Experts on this topic
Elizabeth B. Andrews, Ph.D., MPH, VP, Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, N.C.; RTI Health Solutions provides consulting and research expertise to design risk-management programs, evaluate disease burdens, assess safety, and measure value for pharmaceutical, biotech, and medical-device products. For more information, visit rtihs.org.
Vikram Dev, M.D., VP, U.S. Clinical Drug Safety, AstraZeneca Pharmaceuticals, Wilmington, Del.; AstraZeneca is a leading pharmaceutical company, dedicated to the discovery, development, manufacture, and marketing of high-quality, effective prescription medicines. For more information, visit astrazeneca.com.
Richard Gliklich, M.D., President and CEO, Outcome, Cambridge, Mass.; Outcome provides postapproval strategies and information-based solutions. For more information, visit outcome.com.
Leanne R. Larson, MHA, VP, Strategic Consulting, Ovation Research Group, Highland Park, Ill.; Ovation, a division of Icon Clinical Research, designs and conducts disease and product registries, and prospective pharmacoeconomic and quality-of-life analyses. For more information, visit ovation.org.
Margaret “Peggy” M. McHugh, Formerly VP, Strategy and Development, Registrat Inc., Lexington, Ky.; Registrat designs and implements late-phase studies for sponsors to optimize clinical and commercial benefits. For more information, visit registrat.com.
Robert Reynolds, Sc.D., Executive Director and Head, Epidemiology, Safety and Risk Management, Pfizer Inc., New York; Pfizer discovers, develops, manufactures, and markets prescription medicines for humans and animals and many consumer brands. For more information, visit pfizer.com.
Annette Stemhagen, DrPH, FISPE, VP, Epidemiology and Risk Management, United BioSource Corp., Bethesda, Md.; UBC delivers science-based solutions to support the development and commercialization of pharmaceuticals, biotechnology, and medical devices. For more information, visit unitedbiosource.com.