Webinar Date/Time: 03 Aug 2021, 10:00 EST | 07:00 PST | 14:00 GMT | 16:00 CET | 19:30 IST
An effective signal detection process requires a multidisciplinary and heterogeneous approach including implementation of precision methodologies, where applicable. These methodologies will be based on selection of unique thresholds for signals of disproportionality (SDRs) for:
- Targeted special population such as pregnancy and pediatrics
- Nature and severity of the events such as designated medical events, fatal events, and product-specific events
- Specific products such as anti-cancer drugs or medicinal products for rare diseases
- Selection of the Medical Dictionary for Regulatory Activities (MedDRA) level and literature search strategies
- Defining criteria for identifying signals during clinical assessment for scenarios such as rare adverse events or emerging safety signals during clinical studies where statistical methodologies may not be very efficient in the absence of larger datasets
Register for our upcoming webinar to learn more about:
- The best practices and increasing trends of precision methodologies specific to product types such as
- Biologics, e.g., vaccines
- Cell and gene therapy products
- Medical devices
About the speakers: