A New Era of Drug Safety


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Product Description

As regulators around the globe demand more data on each drug’s profile, the need for technologies to support drug safety has become more pressing. This will require companies to invest in more advanced pharmacovigilance technologies and to develop new processes for the analysis of adverse events both in the postmarketing environment and during development.
A component of the Food and Drug Administration Amendments Act (FDAAA) of September 2007 requires sponsors of drug and biological products that are subject to the risk evaluation and mitigation strategies to submit a proposed REMS. This is a way to manage a known or potential serious risk associated with a drug or biological product. This is an expansion of the RiskMAPs the agency had previously required.
In Europe, new legislation requires companies to collect, collate, and evaluate information about suspected adverse reactions. The EU now requires companies to submit Periodic Safety Update Reports (PSURs), which is intended to provide an update of the worldwide safety experience of a product. The reports have to be filed every six months for the first two years on the market…

Sound Bites From The Field

Dipti Amin, M.B.B.S., is Senior VP and Global Head, Quintiles Drug Safety and Medical Affairs, Research Triangle Park, N.C., which provides a broad range of professional services in drug development, commercialization, and strategic partnering for the pharmaceutical, biotechnology, and medical-device industries. For more information, visit
Robert Bader, Pharm.d., is Director, Product Safety Services, Periapproval Services, at Covance Inc., Princeton, N.J., a comprehensive drug-development services company. For more information, visit
Tara Ferguson is Director, Pharmacovigilance Operations, Parexel International Corp., Waltham, Mass., a global services organization that provides expertise in integrated clinical development, medical communications, and regulatory affairs, as well as technologies to expedite time-to-market. For more information, visit
Kris Gustafson is Senior VP, Interactive Technologies & Lifecycle Sciences, Icon Clinical Research, North Wales, Pa., a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical-device industries. For more information, visit iconplc.
Ken Hintze, Ph.D., is VP, Global Clinical Safety and Pharmacovigilance, at Kendle, Cincinnati, a global clinical research organization providing a full range of early- to late-stage clinical development services for the world’s biopharmaceutical industry. For more information, visit
Sameer Thapar, Pharm.D., is Director, Global Safety Surveillance and Pharmacovigilance, Omnicare Clinical Research, King of Prussia, Pa., a Phase I to IV contract research organization serving the biopharmaceutical and medical-device industries. For more information, visit
A Different Model for Spontaneous Reporting

Experts on this topic
Amy Campbell
. Senior Manager, Field Solutions, Siperian Inc., Foster City, Calif.; Siperian, a provider of a flexible master data management platform, helps companies unify their critical data about customers, products, and organizations. For more information, visit
Michael Ibara, Pharm.D. Head of Pharmacovigilance Information Management, Pfizer Inc., New York; Pfizer is a research-based biomedical and pharmaceutical company. For more information, visit
Steve Jolley. VP, Pharmacovigilance, Patni Life Sciences, Bridgewater, N.J.; Patni Life Sciences is a consultancy that provides regulatory compliance and system life-cycle services to address the unique business and information technology challenges faced by life-sciences companies. For more information, visit
Kris Joshi, Ph.D. Senior Director, Strategy and Business Development, Oracle Health Sciences, Oracle Corp., Redwood Shores, Calif.; Oracle is an enterprise software company. For more information, visit
Ruchi Mallya. Associate Analyst, Pharmaceuticals & Vertical Markets Technology, Datamonitor, New York; Datamonitor provides online data, analytic, and forecasting platforms for key vertical sectors. For more information, visit
Bruce Palsulich. Chief Innovation and Strategy Officer, Relsys International Inc., Irvine, Calif.; Relsys International provides system solutions for drug safety, pharmacovigilance, and risk management. For more information, visit
Nagaraja Srivatsan. VP, Head of North America, Life Sciences, Cognizant, Teaneck, N.J.; Cognizant is a provider of information technology, consulting, and business process outsourcing services. For more information, visit
Annette Stemhagen, Dr.PH. VP, Epidemiology and Risk Management, United BioSource Corp., Bethesda, Md.; UBC is a global pharmaceutical services organization that helps emerging and established life-sciences companies develop and commercialize medical products. For more information, visit