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| Contact |
Europe, DIA,
Postfach
Basel, Switzerland.
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| Description |
This workshop will provide a comprehensive approach of risk assessment and risk management of medicinal products used in pregnancy and lactation. Both pre-clinical and clinical aspects will be considered. Regulatory guidelines will be presented and discussed.
KEY TOPICS
•Risk assessment and risk management of teratogenicity in humans
•Risk assessment and risk management of fetal and/or neonatal toxicity and lactation in humans
•Pre-clinical aspects of risk assessment and management of reproductive and developmental toxicity
•Labelling of pregnancy section in the Summary of Products Characteristics (SPC), the Risk Management Plan (RMP) and the risk communication media.
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