Introduzione

A pharmacovigilance agreement (PVA) is a written agreement between a marketing authorization holder (MAH) and a third party to which the MAH has shared activities regarding or impacting pharmacovigilance. It outlines the responsibilities of each party. Therefore, PVAs 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?
  • Exploring the life cycle of a PVA – from inception to termination
  • What is the difference between PV language in the underlying agreement and a full PVA?
  • What is current best practice when it comes to negotiating PV language / PVAs with partners?
  • What must an in-house lawyer remember and oversee?

PV and safety personnel as well as Legal

Interactive training course

Docente/i
Anna-Shari Melin
Info

Anna-Shari Melin

Senior Managing Associate at Sidley Austin LLP
Anna-Shari Melin is a life sciences lawyer and German Rechtsanwältin. Her practice combines EU and German regulatory, compliance, and private equity/M&A expertise. Her clients are pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer good companies. Anna’s regulatory advice spans the product life cycle including analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs and market access, pharmacovigilance, medicinal product shortages, recalls, the new medical devices regulations, pharmaceutical/device advertising, and related compliance. Anna has vast experience in multijurisdictional regulatory matters. She practices out of Munich and works closely with colleagues from Sidley’s Brussels, London, Geneva, and U.S. offices. Anna co-leads Sidley’s benchmarking group for in-house pharmacovigilance lawyers (pvlegal) and regularly speaks on timely pharmacovigilance topics. Anna has represented clients in matters before the European Commission, the European Medicines Agency, and numerous Member State authorities, including those in Germany. She has also been semi-seconded to numerous international pharmaceutical and biotech companies, becoming a right hand to senior in-house lawyers.  

This online training consists of 1 module:

12 April 2023 from 9:00 am to 1:00 pm 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: € 465,00* until 22/03/2023

Ordinary: € 595,00*

Freelance – Academy – Public Administration**: € 370,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – 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.

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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>
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Pharmacovigilance Agreements