Pharmacovigilance and Regulatory Experience

A large company was notified by Pharmacovigilance Risk Assessment Committee (PRAC) of a serious product safety issue that might lead to a suspension of the Marketing Authorisation (MA). PRAC provided questions for response in a short timeframe. A crisis team was set up to review the pharmacovigilance database for the product, to present their findings to the internal Safety Board to determine the company position.


While acknowledging concerns, it was determined that the benefit risk remained positive. An Oral Explanation was requested by PRAC which included a robust discussion in defence of the product and questions about methodologies to determine safety signals. The company proactively proposed a set of Risk Management and Risk Minimisation measures as well as some specific follow up investigations. Taking a proactive approach and acknowledging some concerns, the company maintained the MA allowing a defined patient group to continue to benefit from the medicine. 



In a separate case, a large company was informed of an Article 20 review. As in the above case, a specific crisis team was established to address these concerns and respond to extensive questions. The team reviewed and determined the company position on the specific event and took proactive steps to examine epidemiological databases to better understand its incidence and prevalence. 


After multiple meetings with the Rapporteur and written responses to CHMP a final Oral Explanation was arranged. At this meeting the company presented its position. This included relative risks based upon comprehensive analyses of multiple databases, as well as clearly articulating the benefit that the medicine brought. Being well prepared and establishing a dedicated team who were able to back up its arguments with robust data, the company convinced CHMP of the merits of maintaining the medicine's availability.


Please contact us for a discussion of how our experience can assist in safety data planning and other Regulatory interactions to successfully share expectations of uptake and review.

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