Pharmacovigilance Refresher & Update – Webinar 2021

Excelya>Pharmacovigilance Refresher & Update – Webinar 2021
Webinar Attendance Form - Excelya Nov 25th

Back by popular demand, our Pharmacovigilance team’s annual refresher webinar will allow you to get up to date with all changes in Vigilance legislation and practices from the past year.

Get up to speed with how COVID has affected PV activities, Good Pharmacovigilance Practices (GVP) and a refresher/overview of the latest EU framework.

Simply download an attendance form and send it back to us at to finalize your registration.

Webinar Information

Where? Web Meeting, Microsoft Teams

When? Thursday, 25 November 2021, 10:00 – 12:00 CET

Who shall attend? Pharmacovigilance (PV) Personnel, or personnel performing PV activities


  • Discussion on major topics for GVPs
  • Provide overview to changes in Vigilance legislation and practices
  • Serve as the annual refresher/update PV training for PV personnel

Trainers: Anastasia Marouda: Safety Manager, LCPPV, deputy QPPV, PV Auditor. PV professional since 2006.

Anastasia is a member of the Excelya PV and Safety Department, participating in the management of the Excelya PV system and network that provides services to more than 85 Clients in more than 45 countries.


Training Agenda

Pharmacovigilance (PV) Refresher and Update

  • Introduction
  • Overview of EU framework including latest updates
  • PV System Requirements – latest updates
  • Good Pharmacovigilance Practices (GVP) on EU level/ Post-Marketing overview
  • Revision 3 GVP XVI & Addendum II main updates and challenges for stakeholders
  • Effects of COVID-19 on PV activities
  • Other PV updates and PV Horizon
  • Other Vigilance major updates
  • Q&A session
  • A certificate for this training will be issued.

The training material and the language spoken will be in English. The training material will be provided to the attendee(s) in e-copy.


Cost per participant: 250 €

For information regarding registration or for more than 1 participant from the same company, please contact


Photographing/recording of the seminar is not permitted.


Data Protection Information

This notice aims to provide you (hereinafter, “data subject”) the information required under Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, (“GDPR”) and other applicable laws regarding the processing of personal data. Personal data will be processed by Excelya Group SAS (hereinafter, “Excelya” or “controller”), as a controller. The contact details of the controller and of its Data Protection Officer (DPO) for any issues related to data protection, are or 738 rue Yves Kermen 92100 Boulogne Billancourt.

Your personal data will be processed for the following purpose(s) and in accordance with the following legal bases: (i) managing and carrying out webinars, trainings, and corporate events (hereinafter, “events”) that you have signed up for, for the performance of a contract to which you are a party and (ii) inviting you to other events organised by Excelya, if you give us your consent in the attendance form above. Where information is not provided, or it is incomplete or inaccurate, this will affect our ability to adequately enable you to attend the event(s).

In both cases, personal data may be shared and/or disclosed: (i) within Excelya group companies for internal administrative purposes; (ii) with processors and sub-processors (third-party providers); and (iii) where legally required or where required in the context of regulatory inspections or audits, with competent authorities, clients, auditors, or other legally foreseen recipients. In the context of the systems and applications used for the aforementioned purposes, personal data may be processed in third countries outside of the European Economic Area. In this regard, the mechanisms used to transfer data may include adequacy decisions (art. 45 GPDR) or standard data protection clauses (“SCCs”) (art. 46.2 GDPR).

Moreover, your personal data will be stored and processed for the time necessary to adequately manage and carry out the event(s) and, if we have your consent, to invite you to other events organised by Excelya, for a period of two (2) years after the end of the event you signed up for. In addition to the aforementioned cases, your data will be kept until you exercise your rights (e.g., you withdraw your consent), or for the establishment, exercise, or defence of legal claims.

In relation to your personal data, you have the right to access, rectification, erasure, restriction, data portability, and to withdraw your consent. Please note that such rights are not absolute and may be limited or restricted in certain circumstances, where there is a legal ground for such limitation or restriction or depending on the applicable legal basis for processing. In order to exercise your rights, you may do so by contacting In certain cases, additional information may be requested to confirm your identity. You also have the right to lodge a complaint with a supervisory authority, in particular, in the Member State of your habitual residence, place of work or place of the alleged infringement, if you consider that the processing of your personal data infringes the GDPR.

Simply download an attendance form and send it back to us at to finalize your registration.