Signal Management in Pharmacovigilance MasterClass - US edition

During the two half training days participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management sessions, pragmatic approaches, real life examples, lessons learned, as also processes for signal management will be discussed.

27-28 November, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

The focus of this two half day training will be on providing an update of ongoing activities regarding medicines’ signal management.

During the two half training days participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management sessions, pragmatic approaches, real life examples, lessons learned, as also processes for signal management will be discussed.

Finally, during this training an outlook of the interactions between Drug Safety and other internal (e.g. Regulatory Affairs) and external stakeholders (health Authorities) will be given. How we communicate efficiently signals, Emerging safety issues (ESISs) and other safety communications (i.e. DHPCs) will be discussed.

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RECOMMENDATION

Who should attend?

• Individuals involved in risk management planning, risk minimisation development and post authorisation safety studies at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
• Risk communication experts
• Qualified Persons responsible for Pharmacovigilance (QPPVs)
• Individuals involved in pharmacovigilance, safety database, signal management and information management