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Pharmacovigilance and Risk Management

30 Mar 23

Challenge

A company with a major marketed oncology product loses the Lead Clinical Safety physician, threatening defence of the label at EMA and FDA and further development plans.

Solution

tranScrip provided at short notice a highly experienced oncology drug safety physician, who assumed global safety leadership.

Result

The development programme was able to continue and the label extensions were successfully negotiated with the regulatory agencies.

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