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
Anna-Shari Melin
Info

Anna-Shari Melin

Senior Managing Associate at Sidley Austin LLP

ANNA-SHARI MELIN is a leader of the German life sciences practice in Munich. Her practice combines EU and German regulatory, compliance, environmental, social and governance (ESG) as well as private equity/M&A experience. Her clients include pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer goods companies.
Anna has vast experience in product lifecycle multijurisdictional regulatory matters. Her clients value her analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs, pharmacovigilance, supply chain management including shortages prevention, product recalls, marketing and advertising, interactions with healthcare professionals and related compliance, as well as due diligence for life sciences transactions. Anna has advised several international clients, including U.S. food supplement clients, on strategic market entry in Germany and the EU.
Anna has represented clients in matters before the European Commission, the European Medicines Agency, the European Court of Justice and the German Federal Court of Justice (Bundesgerichtshof), for example in pay-for-delay appeals.
She has also been semi-seconded to numerous international pharmaceutical and biotech companies, becoming a right hand to senior in-house lawyers in all their interactions with internal clients, contract partners and Member State regulatory authorities, including those in Germany and the Netherlands. Anna has trained in-house lawyers in relation to the preparation of pharmacovigilance agreements (PVAs), the roll-out of compassionate use programs in a multitude of jurisdictions and compliance with the new EU ESG framework such as the German Lieferkettensorgfaltspflichtengesetz and the proposed Green Claims Directive.
Anna co-leads Sidley’s benchmarking group for in-house pharmacovigilance lawyers (pvlegal) and regularly speaks on timely pharmacovigilance topics. She also co-leads Sidley’s Life Sciences ESG Roundtable, a discussion forum for in-house counsel to exchange in relation to the EU’s evolving sustainability/ESG legislative framework.

 


Nadja Schwarz
Info

Nadja Schwarz

Associate at Sidley Austin LLP

NADJA SCHWARZ advises on all aspects of German business and corporate law, with a particular focus on life sciences and domestic and cross-border mergers and acquisitions. Her practice combines EU and German regulatory, compliance, and private equity/M&A knowledge. Nadja’s clients include domestic and international private equity funds, asset managers, strategic investors, pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer goods companies.


This online training consists of 2 modules:

MODULE 1 | 21 May 2024 from 9:30 am to 11:30 am CEST

MODULE 2 | 22 May 2024 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: € 480,00* until 30/04/2024

Ordinary: € 610,00*

Freelance – Individual – Academy – Public Administration**: € 380,00*

* 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>