In Room

Desafios atuais de Farmacovigilância – Edição 2024

In Room

Desafios atuais de Farmacovigilância – Edição 2024

May 23, 2024
Hotel Meliã Oriente Lisboa - Av. D. João II, Parque das Nações, 1990-083 Lisboa


Pharmaceutical industry professionals (Pharmacovigilance).


The training will be moderated by Mariana Rocha, Pharmacovigilance Department Director at Owlpharma.


This training is designed to provide pharmacovigilance professionals with advanced knowledge and skills to navigate the evolving landscape of drug safety and regulatory compliance in an increasingly interconnected world. Through the sessions, participants are invited to explore current relevant pharmacovigilance topics.


Discussion of several relevant topics on pharmacovigilance field, namely: Artificial intelligence, computerized systems, quality assurance in ICSR processing, advanced pharmacovigilance requirements and practices, and orphan and biotechnology medicinal products. From cutting-edge technology, regulatory requirements and challenges for specific medicinal products, these topics constitute important challenges for Marketing Authorisation Holders and pharmacovigilance professionals. By fostering collaboration and critical thinking, this training empowers pharmacovigilance professionals to proactively address emerging challenges and drive continuous improvement in drug safety initiatives.

Conteúdo Programado

Artificial Intelligence in  Pharmacovigilance – Potential updates from regulators and future challenges

Jose Alberto Ayala Ortiz - PVpharm CEO, Pharmacovigilance Consultant, QPPV, PV Auditor

Computerized systems and databases - Compliance with the GVP requirements, auditor perspective and expectations

Ana Maria Tomé - Consulting (GVP Team), ADAMAS Consulting

ICSR processing through quality assurance lens - Collection, data entry, assessment, quality control,  follow-up

Sara França - Pharmacovigilance Manager, Owlpharma

Beyond GVPs - Practices in PV system management that evidence compliance with the requirements

Ricardo Andrade - Owlpharma Managing Director, QPPV, PV auditor

Pharmacovigilance in orphan and biotechnology medicinal products - Special requirements and challenges on the PV activities

Jan Kolouch - CEO / EU QPPV / Strategic PV Advisor at NextPV Services

The sessions will be presented in English.
The content of the programme may be subject to change.


An email will be sent confirming your registration and payment details.The registration will not be finalised until payment has been confirmed.


Registration until 03/05/2024:

  • 450 € + VAT / person
  • 400 € + VAT / person (for registrations of 2 or more people from the same company)

Registration after 03/05/2024:

  • 550 € + VAT / person
  • 500 € + VAT / person (for registrations of 2 or more people from the same company)

Join the event

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After submiting this form you will then receive an email with the confirmation of vacancy and payment details. Registration will only be completed after confirmation of payment. The registration fee includes coffee breaks and lunch.

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