Roll up your sleeves for a two-day, introductory workshop on how to prepare an effective electronic Common Technical Document (eCTD) submission. This in-person workshop includes skill-building, interactive exercises, case studies and small group discussions.
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A look at the blended approach and other options for an
outsourced pharmacovigilance model and their benefits for small pharmaceutical
companies. This article provides advice on the steps required to complete a
successful PV outsourcing project.
A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company’s subsidiaries.
ANVISA, Brazil’s medical device market regulatory agency, has published new requirements for conducting clinical testing of devices in the country.
The US Food and Drug Administration (FDA) has announced the landmark approval of the US' first biosimilar product, Sandoz' Zarxio (filgrastim-sndz), a drug biologically similar to Amgen's Neupogen.