Risk Management plans and its Implementation - EU edition MasterClass

The aim of a Risk Management plans and its Implementation Masterclass is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. 

07 - 09 November, 2022, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

A medicinal product is authorised on the basis that in the specified indication(s), at the time of authorisation, the risk-benefit balance is judged to be positive for the target population. Generally, a medicinal product will be associated with adverse reactions and these will vary in terms of severity, likelihood of occurrence, effect on individual patients and public health impact. However, not all adverse reactions and risks will have been identified at the time when an initial marketing authorisation is granted and some will only be discovered and characterised in the postauthorisation phase. The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. The different aspects of the sequences of Risk Management (Safety Specifications, Risk Management Plan and Risk Minimisation Measures and their Evaluation will be analysed.

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RECOMMENDATION

Who should attend?

• PV Personnel

• Operational Marketing Staff

• Sales Responsibles

• Vendors of Pharma Companies

• Business Development

• QPPVs

• Regulatory Affairs Managers

• Regulatory Affairs Technicians

• Medical Department Staff

• Product Managers