Introduzione

A pharmacovigilance agreement (PVA) is a written agreement between a marketing authorization holder (MAH) and a third party with which the MAH has shared activities regarding or impacting pharmacovigilance. It outlines the responsibilities of each party. PVA preparation and management are an integral part of a solid pharmacovigilance system.

The goal of the training is to get an overview of the array of provisions that are included in PVAs and discuss current hot topics regarding PVAs. The course will also consider whether a full PVA is always necessary, i.e., when inclusion of PV language into the underlying commercial agreement may be sufficient and what this language could look like. We will explore current hot topics in this regard, so the audience understands both current best practice and how this best practice may evolve in the next few years.

  • Legal framework – why do we need PV language or a PVA?
  • What is the difference between PV language in the underlying agreement and a full PVA
  • Exploring the life cycle of a PVA – from inception to termination
  • What is current best practice when it comes to negotiating PV language / PVAs with partners?
  • Q&A/workshop
  • Review of PVA clauses and request for audience to help review and update as needed
  • What must an in-house lawyer remember and oversee?

PV and safety personnel as well as Legal

Interactive training course and workshop

Docente/i
Olivier Goarnisson
Info

Olivier Goarnisson

Lawyer at Goarnisson Life Sciences & Law

OLIVIER GOARNISSON is both a qualified lawyer and physician. He advises on matters related to European Union and Swiss life sciences regulatory law with a special focus on pharmacovigilance, clinical trials and other clinical studies, healthcare data, the manufacturing and distribution of healthcare products, including the related supply chains, medical affairs and the promotion of healthcare products.
From 2004 to 2010, he practiced in the Brussels office of Sidley Austin LLP where he advised life sciences industry clients on regulatory matters, clinical trials, pharmacovigilance and data protection. He then spent eight years at the European headquarters of a pharmaceutical company, where he gained further legal, management and leadership experience. As Director of Medical Affairs Operations, he supervised the execution of post-authorization studies and related interactions with regulatory authorities. He also oversaw programs through which the company provided support for academic research in Europe. In this role, he ensured compliance of the company’s academic support programs with anti-corruption and pharmacovigilance requirements. He also helped the company manage intellectual property and product liability risks.
Olivier returned to Sidley Austin in November 2018 to help launch Sidley’s Life Sciences practice in Switzerland. He continued practicing law in the areas mentioned above, with a stronger focus on medical affairs and the manufacturing and distribution of medicines and medical devices, including the related supply chains.
Olivier left Sidley in 2024 to start his own life sciences law practice in Switzerland, near Zürich and Zug.


This online training consists of 2 modules:

MODULE 1 | 07 May 2025 from 9:30 am to 11:30 am CEST

MODULE 2 | 09 May 2025 from 9:30 am to 11:30 am CEST

After the registration, 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: € 515,00* until 16/04/2025

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

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Define the elements of a PVA
Risultato atteso
Understand alternatives to having a stand-alone PVA
Risultato atteso
Define potentially new approaches to PV language
Risultato atteso
Be up to date with respect to hot topics regarding PVAs
Risultato atteso
Know which legal developments to monitor in European PV
Risultato atteso
Be aware of best practice considerations relevant to PV language

<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>