Introduzione

Within the pharmaceutical industry, ensuring patient safety and regulatory compliance is of utmost importance. One key position that plays a critical role in this regard is that of the Qualified Person for Pharmacovigilance (QPPV). The QPPV oversees the safety of medicinal products and ensures compliance with pharmacovigilance regulations. The requirements for the QPPV originated in the EU, but this role has evolved and expanded over time in non-EU territories as well.

This workshop will provide an overview of the role and responsibilities of the QPPV in EU and non-EU Territories, highlighting the evolution of this role over time and geographically.

This workshop will also focus on the challenges and opportunities that QPPVs in pharmaceutical companies with an international footprint are currently facing in order to maintain oversight of the global pharmacovigilance system in a highly regulated environment and in a constant state of inspection-readiness. Practical scenarios, best practices and strategic QPPV oversight process will be discussed in a very dynamic setting, where interaction among speakers and participants is an essential feature and key to the success of this workshop.

  • Introduction: setting the scene for the role and responsibilities of QPPV
  • The “global” QPPV: evolution of the role in EU and non-EU territories
  • How to be a successful QPPV: practical scenarios and best practices for robust and effective PV system oversight (including PSMF preparation and maintenance.

Senior Managers and Pharmacovigilance managers, QPPVs and Local Safety Officers, Pharmacovigilance Officers/Drug Safety Specialists, anyone working with Pharmacovigilance and aimed to get a background in the QPPV role/responsibilities.

Participant experience
At least 2 years of experience in Pharmacovigilance, or in PV Quality/Compliance roles

PowerPoint slides and brief presentation will be utilized to introduce topics for discussion.
Interactive sessions will be moderated by the workshop speakers, and participants will be stimulated to actively contribute to the discussion in a dynamic and psychologically safe mode. Quick polls using free apps could be utilized.

Docente/i
Ilaria Grisoni
Info

Ilaria Grisoni

Exec. Dir., Head of EU/International PV & Risk Management, EEA QPPV at Jazz Pharmaceuticals

After a degree in Medical and Pharmaceutical Biotechnology in 2008 at Vita-Salute San Raffaele University in Milan, she started to cooperate at the Pharmacovigilance unit of OPIS Srl as a PV Associate.
In 2010, she joined Gentium SpA, initially as a Safety Officer, then as Deputy EEA QPPV (2011-2014), and finally as EEA QPPV (2015-2016).
In 2016, she upgraded to Deputy EEA QPPV for Jazz Pharmaceuticals, in April 2018 she took on the role of EEA QPPV, and since November 2020, she has been in charge as Head of EU/International PV & Risk Management, as well as EEA QPPV at the same company.
She is an active member of the Pharmacovigilance Working Group of Farmindustria, of the Italian Society of Pharmaceutical Medicine (SiMeF), and the PV Connect group of Navitas Life Sciences.
She also collaborates as a speaker/lecturer for conferences and seminars in Pharmacovigilance field.


Elena Colombo
Info

Elena Colombo

EU/Int PV & QPPV Office, Deputy EEA QPPV at Jazz Pharmaceuticals

She graduated in Biological Sciences in 2001, after obtaining a PhD in Cellular and Molecular Biology from Vita-Salute San Raffaele University in Milan, in collaboration with the Open University of London, she began her career in the pharmaceutical field in 2006 at the Medical department of CSL Behring, in 2009 she took on the role of local Pharmacovigilance manager at the same company.
In 2011, she started to cooperate with Pfizer as a Safety Surveillance Assistant, where she spent a couple of years before moving to Gentium/Jazz Pharmaceuticals in 2013, upgrading to Drug Safety Officer and later to Senior Manager QPPV Office. She has been Deputy EEA QPPV for Jazz Pharmaceuticals since 2018, and since 2020, she has been a member of the EU/Int PV & QPPV Office, where she manages a team focused on the management of harmonized PSMFs between EU and non-EU countries.


Online Training – 1 module

28 November 2024 from 9:00 am to 1:00 pm CET

Few days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 510,00* (until 7 November 2024)

Ordinary: € 645,00*

Freelance – Individual – Academy – Public Administration**: € 435,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Registrati
Early bird
Acquistabile fino al 07/11/2024
510,00
Ordinaria
Acquistabile fino al 27/11/2024
645,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 27/11/2024
435,00
Svuota

Francesca Archetti
Francesca Archetti
Marketing & Sales Specialist
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the evolution of the role and responsibilities of the QPPV, including oversight of the pharmacovigilance system.
Risultato atteso
Learn about global regulatory requirements and guidelines related to QPPV.
Risultato atteso
Establish a robust and effective QPPV oversight process, including delegation of task, maintenance of the PSMF, and quality management.
Risultato atteso
Prepare for inspection/audit as a QPPV, based on the PV inspection types.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>