EMA to encourage use of Scientific Advice for Post-Authorisation Safety Studies

12-month pilot will support design of high-quality safety studies!

The European Medicines Agency (EMA) is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorisation safety studies (PASS) for medicines. This voluntary, optional procedure will help to improve the design of studies meant to collect further information on a medicine's safety once it is on the market. This pilot will build on the expertise of the Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

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