Elaboration of safety management plan for clinical trials
Dates TBD

Elaboration of safety management plan for clinical trials: key points and recommendations

English | 
Ensure trial safety with precision: Craft a robust Safety Management Plan to safeguard participants and ensure regulatory alignment.

Sponsor, Investigators and third parties involved in a Clinical Trials shall be coordinated and know in depth their responsibilities regarding the management of safety information may arise during the conduct of the study, at this point, elaborating a Safety Management Plan will be essential. Participants will learn how to elaborate a Safety Management Plan to manage the safety of the Clinical Trial: collaboration with other parties involved, Safety database maintenance, SAE management, Reconciliations and ASR elaboration & submission.

This course provides key points for a success management of a Clinical Trial through the elaboration of a Safety Management Plan.

  • Parties involved in the safety management of clinical trials:
    It will be defined the parties involved in a Clinical Trial and functions they have as per Regulation.
  • Safety Management Plan (SMP):
    Introduction and description of the main sections to be included in a SMP.
  • Responsibilities:
    Responsibilities of each party. Steps to be followed if some activities are externalized to a third party.
  • SAE processing:
    Description of main steps to follow to exchange SAEs between the parties and other events of interest. Concepts, timeliness, responsibilities, and definitions that all parties involved must be aware will be clearly explained.
  • SUSAR reporting:
    How to report and whom must be informed when a SUSAR occurred is one of the most important points to be defined.
  • Reconciliation:
    The maintenance and alignment of both databases, clinical and safety is a critical task when conducting a clinical trial. To know and describe how to perform a reconciliation between both databases is essential.
  • Annual Safety Report:
    An annual safety report to analyse aggregate safety data is mandatory.
  • Safety management of Medical Devices:
    Key points to be considered if the Clinical trial is designed to evaluate a Medical Device

Sponsor, Investigators, pharmacovigilance Department and third parties involved in the management of the Clinical Trials Safety.

Helena Belinchón
Drug Safety Associate Director

Master Degree in Pharmacovigilance & Pharmacoepidemiology, as well as Pharmacy Degree.

Solid experience in Pharmacovigilance, Clinical Trials and Contract Research Organization

The course is delivered in one 4-hour session from 2 p.m. to 6 p.m.

Price: 400€

Early Bird: 10% discount up to 30 days before training date.

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