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Aug 31, 2015

DIA has launched its August edition of Global Forum Online which features a whole section on quality in clinical trials. Editor of this special edition Beat Widler and two more contributions, among others, by Widler & Schiemann AG.

Free trips to luxury destination for medical conferences and lavish dinners or entertainment will be banned under a new Sunshine Act like rule announced by U.K. Health Secretary Jeremy Hunt on Sunday, 23. August. NHS staff found to be abusing their position by taking extravagant gifts or lobbying for medicines with the intent of personal gain could face steep consequences if found guilty — including fines, or even jail time, Hunt said in a release.

Auditing in GCP is facing new challenges with the latest developments in clinical research, i.e. risk-based monitoring, etc.

Beat Widler & Peter Schiemann contributed to this latest issue of GCP auditing with a view on the new situation.

This document is the seventh annual report of the Pharmacovigilance Inspectors Working Group. Majority of the findings in 2014 were in the following areas: quality management system, adverse event reporting and communication with national competent authorities.

This guidance assists sponsors of drug and biological products intended to treat or prevent rare diseases in conducting more efficient and successful development programs through a discussion of selected issues commonly encountered in rare disease drug development. Although similar issues are encountered in other drug development programs, they are frequently more difficult to address in the context of a rare disease with which there is often little medical experience.