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May 13, 2016

Widler & Schiemann together with 3 Audit, a Bejing-based Audit Services Company (http://www.jwcqo.com/en/, http://3audit.com), opened their subsidiary in Shanghai in April. The subsidiary will be managed by Dr. Peter Schiemann, who moved to Shanghai to build our Asia-Pacific practice. Many guests from pharmaceutical companies and hospitals attended the opening ceremony. We are very proud to be able to offer to our clients now a support directly out of China.

EMA 29/04/2016 Newsletter: What's new in pharmacovigilance - QPPV Update - Issue 1

29/04/2016 Regulatory and procedural guideline: Reflection paper on collecting and reporting information on off-label use in pharmacovigilance, draft: consultation open

29/04/2016 Pharmacovigilance: Regulatory and procedural guidance (updated)

28/04/2016 Quality of medicines questions and answers: Part 2 (updated)

The biopharmaceutical industry is starting to adopt TransCelerate’s Risk Assessment Categorization Tool (RACT) in order to identify risks and plan a comprehensive clinical trial risk mitigation strategy. But how good is it really? Does it address all requirements by regulators?

In this article, we will leverage industry-wide RACT data (provided by Cyntegrity) to see what are the most common study-related risks that people choose.

Widler & Schiemann are now also accredited with the SCS (Swiss Center in Shanghai), a non-profit organization serving the Swiss economy by providing adapted services for SME’s intending to and/or entering the Chinese and/or the Asian markets. In the past 10 years, SCS has created a pool of services through companies accessing these markets with a full range of practical, direct and accredited services offered at favorable conditions and integrated tailor-made packages to provide truly efficient solutions.