Introduzione

GVP Module I says: "Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes by an organisation is intrinsically linked with the availability of a sufficient number of competent and appropriately qualified and trained personnel". This means that all the professionals involved in pharmacovigilance activities have to be continuously and properly trained, according to the roles and responsibilities they cover.

The objective of this course is to make people understand the goals and objectives of pharmacovigilance, examine current legislation, interpret, manage information on drug safety and make known the responsibilities of those who work in the field, so that the participants can acquire the necessary tools to deal with daily operations on an adequate knowledge base. This course provides practical information on the fundamentals and trends in marketing authorization and post-marketing surveillance.

Module 1

  • Clinical trials and legislative framework
  • Studies (clinical trials, interventional, non-interventional, post-authorisation studies)
  • Pharmacovigilance – legislative framework

Module 2

  • Case reporting and case processing
  • Aggregate reports
  • Risk management
  • Signal management

Module 3

  • Pharmacovigilance system and operations
  • Inspection & audit

PV associate, PV Assistant, other PV Staff with basic knowledge, personnel involved in medical information activities, regulatory activities or other personnel involved in activities related to PV.

Interactive presentation with workshop.

Docente/i
Jana Hyankova
Info

Jana Hyankova

Senior PV Director, EU QPPV, UK QPPV at PrimeVigilance
Jana Hyankova is an expert on pharmacovigilance with more than 15 years of working experience from several global pharma companies. Jana joined PrimeVigilance (former PharmInvent) in 2014 and she currently holds the position of Senior PV Director in QPPV Department. She serves as EU QPPV and UK QPPV for several clients and conducts PV audits as requested by clients. Jana is a Medical Doctor who gained her medical education at the Charles University in Prague, Czech Republic. Prior to joining PrimeVigilance, she held managerial pharmacovigilance roles at local (Bristol Myers Squibb) as well as Global (PharmaSwiss SA later Valeant Pharmaceutical International) levels. Outside of PrimeVigilance Jana is chairing RQA Pharmacovigilance Committee and is also an active lecturer of the RQA, PIPA, ISoP and Conforum.
Mercedina del Papa
Info

Mercedina del Papa

Strategic Advisor, EU QPPV, UK QPPV at PrimeVigilance
Mercedina del Papa joined PrimeVigilance in 2021 after 12 years of working in a company that acts as service providers for several pharmaceutical companies. She currently holds the position of Strategic Advisor in the QPPV Department, acting as EU QPPV and UK QPPV for client companies. She has a degree in Pharmacy, a master’s degree in “Pharmacovigilance and Regulatory Affairs” and a second master’s degree in “Management & Pharmaceutical Marketing”. During her professional career, she has specialized in the field of product’s safety especially Human Pharmacovigilance.

This online training is divided in 3 modules

Date TBD

Some 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: € 795,00* 

Ordinary: € 995,00*

Freelance – Academy – Public Administration**: € 515,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – 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.

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Cosa saprai fare dopo il corso
Risultato atteso
Understand and manage the basic processes of pharmacovigilance
Risultato atteso
Implement the pharmacovigilance activities that the regulations in force impose to the marketing authorization holders and/or industries
Risultato atteso
Recognize process and responsibilities within the full PV activities
<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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Fundamentals of Pharmacovigilance