戻る Agenda
On-Demand: Regulatory Science Hub Session
Learning Objective : To identify the main parameters to collect in a registry to be used for regulotory decision-making processes. To compare the collection of data in clinical practice versus the regulatory requirements.
Speaker(s)
Registries to be used in the regulatory decision-making process, what is minimally needed?
Carla Jonker, MS
Medicines Evaluation Board (MEB), Netherlands
Senior Regulatory Project Leader
The impact from EMA’s telematics strategy and SPOR program
Niels Leander, PHD
Eraneos, Denmark
Partner - Life Sciences