Safety/PV regulatory climate

As clinical development matures and marketing strategies are agreed upon, it is important to turn more attention to the regulatory scrutiny and reporting requirements which will follow licensure in the various world markets.  e-Clinical partners have been deeply involved in representing the medical product marketing authorization holder in negotiations with the US FDA, the EMA in Europe, Japanese and other regulators to help the sponsor clearly understand safety/PV rules, reporting timeframes and aggregate reporting requirements and schedules.  Most regulatory authorities have adopted requirements around electronic reporting and are setting schedules for mandatory submissions using newer encoding standards such as E2B version 3.

Adverse events that are serious, unanticipated or life threatening, occurring in patients residing inside or out of the jurisdiction of the regulatory authority or involving conditions which are unlisted on the label often require special processing and timeframes.  Furthermore, database coding and terminology needs as well as requirements around MedDRA and WHOdrug dictionary updates must be understood and adhered to. The e-Clinical partner will provide expert advice on these issues.