Blog

Sciformix is committed to sharing ideas and insights with the life science industry and support the development and commercialization of safe and effective products. Our employees and partners share their knowledge and thought leadership.

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Prashant Joshi, Director of Domain & Process, Safety and Risk Management at Sciformix Corporation

EMA Announces Release of Updated EudraVigilance System: What this Means to the Industry

Posted Safety & Risk Management Blog


Prashant Joshi
Director, Domain & Process, Safety and Risk Management, Sciformix Corporation

On 22-May-2017, EMA announced the go-ahead for their new EudraVigilance system for collection and monitoring of suspected adverse reactions. This was a much-anticipated and awaited announcement following the recent completion of an independent audit of the system. As per the announcement of...

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Dr. Brent Allan, Executive Medical Director at Sciformix

FDAs Guidance on Safety Assessment Committees – Podcast

Posted Safety & Risk Management Blog


Dr. Brent Allan
Executive Medical Director, Sciformix Corporation

In clinical trials, a comprehensive understanding of the safety profile of the product requires the consolidation of safety data across the same molecule and class. Aggregation and analysis of data are particularly important with the FDAs guidance on Safety Assessment Committees where...

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