We recently spoke to Elizabeth GuÃ©rault, VP, Senior Medical Advisor, Sanofi-Aventis R&D about new sources of product safety data. See below for the interview.
How is your company identifying new sources of product safety data with the current intense focus on drug safety & risk management by regulatory agencies?
Our Company is already committed by regulation to monitor literature for safety information concerning our portfolio, also as part of routine signal detection activities, external safety databases from major health Authorities are explored, such as FDA;, WHo and more recently released Eudravigilance from EMA. New potential sources of safety data such as social media are not systematically scrutinized while websites sponsored by our Company are. Postmarketing reinforcement will bring additional information with both additional efficacy and safety data.
How will the new European pharmacovigilance legislation shape your company's safety activities and work structure in the next 6 months? And what do you see as the main difficulties?
The implementation of a new and large change in regulations is an opportunity to improve/revamp current processes and optimize them. In that way the implementation of the New Pharmacovigilance Legislation is a great opportunity for the entire company. The major challenge faced today is the integration of a full and continuous benefit assessment, especially for our older products.
Prof Guido Rasi, the new Executive Director of the EMA, has expressed his support for the idea of staggered approvals (or adaptive licensing) whereby new drugs can make it to the market faster while safety data is being collected. With this in mind, how do you see the role and capabilities of post-marketing
monitoring of medicines changing in the near future?
Postmarketing activities conducted post approval or post-conditional approval will be followed by health authorities and assessed in even a more transparent environment with question & answers and possibilities of arbitration. Also minimum required safety data to be submitted at the initial step will have to be redefined, per indication and/or types of drugs. I presume this will be, overall, a question of improving the benefit/risk balance for the patient with additional comparative data and real life data.
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