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December 18, 2013

Widler & Schiemann AG launch monthly Newsletter
Welcome to our new monthly Newsletter!

Widler & Schiemann AG are proud to present to you our first newsletter. In our monthly newsletter we will inform you about recent developments in regulations and their implication for the pharmaceutical and biotechnical industry, academia and research organizations. We sincerely hope you will find our newsletter informative. If you have any suggestions how to improve it, please let us know.

Meanwhile, we would like to wish you happy holidays and a prosperous and joyful new year!

Update on GDP Guidelines
The EC issues update on Good Distribution Practice Guideline

An updated version of the revised Good Distribution Practice (GDP) guidelines has been issued by the European Commission. This version corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines, and gives more explanations on the rationale for the revision as well as a date of coming into operation.

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EMA finalizes Reflection Paper
The EMA has finalized their Reflection Paper on Risk-based Quality Management of Clinical Trials

Issuing the final version of their reflection paper will change the approach to quality management systems for clinical trials significantly during the next five years. Two significant concepts are mentioned in this Paper that have not been so prominently outlined in the related FDA Guideline: the importance of sharing quality risk information and the need for standardization. In our opinion, these are keys to success. In addition, we also can conclude from our discussions with regulators that what is needed now is to develop clear and concrete concepts about the operationalization implementation of what today are largely theoretical concepts.

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Disclosure of Clinical Trials' Raw Data becoming a Priority
An example of thought leadership of Beat Widler of Widler & Schiemann AG

It was 2007, and Beat Widler had then already developed this long-shot approach that today is being considered by industry, non-profits and other stakeholders.

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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 - -