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E-Submissions: On the Brink of Going Paperless

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Product Description

The shift from static paper regulatory applications to dynamic and interactive electronic submissions will make data more accessible to reviewers and, ultimately, improve the efficiency of the review process.
December 15, 2004, was a day unlike any other at Wyeth Pharmaceuticals. That Wednesday, the company simultaneously submitted a registration dossier in five regions. But what was so unusual was that the submissions were done electronically.
Wyeth officials submitted an electronic common technical dossier (eCTD) for Tygacil to regulatory officials in the United States, Canada, and the European Union, which includes 25 countries governed by the European Medicines Agency (EMEA). Electronic applications also were submitted to authorities in Switzerland and Australia.
Tygacil (tigecycline) is being developed as an injectable antibiotic for treating serious polymicrobic infections in hospitalized patients when resistant pathogens are known or suspected.
“This is new not only for Wyeth but also for those regions,” says Gina Schmidt, director of global regulatory submissions management at Wyeth, referring to the simultaneous electronic submissions. “To our knowledge, this is something that hasn’t been done before…

Sidebar:
Wyeth’s e-submission for Tygacil

Experts on this Topic
Mark H. Bradshaw, Ph.D. VP, Global Biometrics and Data Management, Covance Inc., Princeton, N.J.; Covance is a drug-development services company. For more information, visit covance.com.
John K. Cline. CEO, etrials Worldwide Inc., Morrisville, N.C.; etrials is a provider of e-clinical software for the efficient collection, cleaning, integration, and review of data in the clinical-trial process. For more information, visit etrials.com.
Kirk Gallion. Chief Operating Officer, Octagon Research Solutions Inc., King of Prussia, Pa.; Octagon is a process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life-sciences industry. For more information, visit octagonresearch.com.
Joan Korth-Bradley. Project manager, Tygacil, Wyeth Pharmaceuticals, Collegeville, Pa.; Wyeth is a research-driven pharmaceutical and healthcare products company. For more information, visit wyeth.com.
Randy Levin, M.D. Director for Health and Regulatory Data Standards, Food and Drug Administration, Rockville, Md.; the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, and cosmetics. For more information, visit fda.gov.
Gina Schmidt. Director, Global Regulatory Submissions Management, Wyeth Pharmaceuticals, Collegeville, Pa.; Wyeth is a research-driven pharmaceutical and healthcare products company. For more information, visit wyeth.com.
Michael A. Walega. Executive Director, Global Biometrics Operations, Late-Stage Development Services, Covance Inc., Princeton, N.J.; Covance is a drug-development services company. For more information, visit covance.com.
James Walker. President and CEO, Octagon Research Solutions Inc., King of Prussia, Pa.; Octagon is a process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life-sciences industry. For more information, visit octagonresearch.com.

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