Pharmacovigilance system implementation by SME MAH
Dates TBD

Pharmacovigilance system implementation by SME MAH. Challenges and recomendations.

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Navigate PV compliance with ease: Tailored strategies for SME MAHs to optimize safety and streamline operations.

SME MAHs should comply the GVPS as well as multinational companies, but the staff and resources are not always in line with the large number of requirements to ensure compliance with Pharmacovigilance legislation.

This course provides the key points for the successful implementation of a Pharmacovigilance system, given recommendations to ensure compliance and save time and resources when is possible.

  • Program

The following Key points related to a PV system implementation will be analysed in the present course:

  • EU-QPPV and company registration
    How to register the company, EU-QPPV and other users in Eudravigilance, the required documentation and tips to the easy management within Eudravigilance website.
  • Pharmacovigilance procedures
    The most relevant procedures to have in place according to GVPs and how to structure the information.
  • Pharmacovigilance system master file (PSMF)
    Elaboration, registration in XEVMPD and maintenance. MFL Code and Summary PSMF.
  • PV agreements (SDEAs)
    Identification of relevant third parties (partners, providers etc) and key information to include in the SDEAs
  • PV organization and outsourcing
    Tips to organize the PV activities and how to manage the delegated activities.
  • PV database
    Selection and implementation of the PV database. Validation and documentation.
  • PV archive
    Access control, security of data, confidentiality, and backup copies.
  • PV quality system
    Minimum KPIs, management of deviation and CAPAs within the PV department
  • Bussiness continuity plan (BCP)
    Definition of the PV BCP and verification tests
  • Targeted audience

Pharmacovigilance managers and technicians from MAHs and Pharmacovigilance service providers.

  • Trainers / Speakers

Sonia López
Pharmacovigilance Director

Master Degree in Pharmacovigilance and Post-Authorisation.

QPPv at ASPHALION.

Solid experience in Pharmacovigilance and Health Product Surveillance in the Pharmaceutical Industry.

Extensive expertise as teacher, trainer in courses, congresses and symposiums. Tutor of training internship students.

  • Price and Conditions

The course is delivered in two 3- hour sessions (6 hours)

From 3 p.m to 6 p.m

Price: Upon request

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

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