Pharmacovigilance literature searches in the digital age
Dates TBD

Pharmacovigilance literature searches in the digital age

Spanish | 
Online
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Empower your pharmacovigilance with digital-age strategies for literature searches – stay compliant and informed!

In accordance with module VI of the GVPs (Good Pharmacovigilance Practices), the MAHs (Marketing Authorization Holders) are required to monitor their accessible sources of scientific articles on a weekly basis with the aim of identifying suspicions of adverse reactions. This course will address the obligations of the MAH, the design of the search strategy, instructions for a correct review of the results and key points when digitizing this process.

  • Program
  • Legal framework and MAH obligations This course will address the information sources to review, the obligations of the MAH from the moment of authorization and the impact on the submission of cases to the authorities, signal detection and periodic safety reports. In addition, the implications of searches conducted by EMA or Medical Literature Monitoring (MLM) and their impact on the searches conducted by the MAH will be reviewed.
  • Design of the search strategy Instructions for the design of the search strategy and selection of keywords as essential aspects to obtain precise results and ensure the detection of relevant safety information.
  • Review of the results Approach to the review of results to correctly detect cases of suspected adverse reactions, possible safety signals and other relevant safety information. Interrelation of the different processes and management of information according to the different obligations of the MAH.
  • Challenges and key points in the digital age Considerations when selecting a tool to digitize the process. From document management and registration to evidence a reproducible process to the implementation of Artificial Intelligence.
  • Targeted audience

Pharmacovigilance managers and technicians from MAHs and Pharmacovigilance service providers.

  • Trainers / Speakers

Miriam Álvarez
Drug Safety Manager

Master Degree in Pharmaceutical Industry.

Extensive expertise in Pharmacovigilance,  as EU-QPPV and as Local PV contact. Preparation of PSURs, PMCF Plans according to Medical Device Regulation (EU) 2017/745.

Collaborator as teacher in Pharmacovigilance courses and AEFI Symposium.

  • Price and Conditions

The course is delivered in one 4-hour sessions (4 hours).

From 2 p.m. to 6 p.m.

Price: Upon request

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

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