Product Description

In the last few years, the FDA has come under strong criticism for the rate of adverse events, high-profile drug recalls, and contamination of both food and drug products. Agency officials have made steps to address drug safety and provide a more open and transparent regulatory environment. For the pharmaceutical industry, this is likely to mean increased oversight.
The FDA has certainly been more conservative in recent years in its approach to benefit and risk, says Richard Lev, chief compliance officer of Publicis Touchpoint Solutions.
“The FDA also has set a very high bar for new drug approvals,” he says. “This is due in part to the public perception of drug safety as well as congressional…

Sidebars:
Framework for Postmarketing ­Studies
Sound Bites From The Field
FDA’s Commitment to Regulatory Science
FDA’s Final Rule on Safety ­Reporting during Trials

Experts
John Blakeley. Executive VP, ERT, a ­global provider of technology and services to the pharmaceutical, biotechnology, and medical-device industries. For more information, visit ert.com.
Jay Bolling. CEO and President, Roska Healthcare Advertising, a full-service ­advertising agency with expertise in ­communications that integrate data and insight-driven marketing and advertising solutions. For more information, visit ­roskahealthcare.com.
Melody Brown. VP, Regulatory Affairs, Millennium: The Takeda Oncology Company, which is focused exclusively on ­oncology to improve the treatment of ­cancer around the world. For more information, visit millennium.com.
Ken Kramer, Ph.D. Senior VP, Medical Director, Alpha & Omega Worldwide, part of The Core Nation, a medical communications agency. For more information, visit ­thecorenation.com.
Richard Lev. Chief Compliance Officer, ­Publicis Touchpoint Solutions Inc., which ­provides a comprehensive and integrated array of outsourced biopharma message ­delivery channels plus full-service support solutions. For more information, visit publicistouchpointsolutions.net.
Jay Norman. President, Consulting Group, Quintiles, which provides data-driven ­recommendations and advice to help ­companies achieve success in pharmaceutical, biotech, and medical-device development. For more information, visit quintiles.com/consulting.
Anne Tomalin. President, i3CanReg, a global regulatory consulting firm that assists pharmaceutical, biotechnology, and ­medical-device and diagnostics clients at all stages of regulatory approval, and ­provides unique customized guidance, education, and training. For more ­information, visit i3global.com.
Rob Vollkommer. Principal, CSC’s ­Global Health Informatics Practice, which is ­dedicated to helping all healthcare ­stakeholders leverage the growing body of healthcare data to improve medical research productivity. For more ­information, visit csc.com/healthinformatics.
Stephen Webb. President, North America, Registrat MAPI, a CRO dedicated to ­providing late-phase research to the global biopharma and medical-device industries. For more information, visit registratmapi.com.
Jay Norman. President, Consulting Group, Quintiles, which provides ­data-driven recommendations and advice to help companies achieve success in pharmaceutical, biotech, and medical-device development. For more information, visit quintiles.com/consulting.
Charles Saldarini. CEO, Sentrx, a provider of drug safety services to the life-sciences industry. For more information, visit sentrx.com.
Rob Vollkommer. Principal, CSC’s ­Global Health Informatics Practice, which is dedicated to helping all healthcare
stakeholders leverage the growing body of healthcare data in ways that will improve medical research productivity. For more information, visit csc.com.
Sanjeev Wadhwa. Partner, Director Life Sciences R&D, CSC Life Sciences Practice, a provider of solutions that improve the way physicians deliver services, governments manage public health, experts conduct breakthrough medical research, and institutions provide coverage. For more information, visit csc.com.