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Aug 31, 2015

 
DIA Global Forum Online August
Contribution on Quality Matters by Beat Widler & Peter Schiemann

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.

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UK TAKES AIM AT PHARMA PERKS
Sunshine rule announced in the UK

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.





Audits in GCP and Beyond
The third issue of GCP auditing will be released soon

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.

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EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014

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.

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FDA issues draft guidance on drug development in rare diseases
This draft guidance is open for comments for the next 60 days.

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.

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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - info@wsqms.com - http://www.wsqms.com