Introduzione

This workshop will focus on activities connected to description of pharmacovigilance system (PV) in pharma companies. Participants will see how complex description of PV system might be and how departments outside PV are involved in description of PV system of a Marketing Authorisation Holder. The workshop will summarize regulatory framework and a presentation will demonstrate various possibilities how to describe PV system. The following workshop will then focus on solving case studies in groups and final discussion including sharing outcome and experience from the workshop.

  • Regulatory framework
  • A presentation and workshop instructions
  • Workshop – case studies: How to compile PV system description in different regions in Global pharma company (discussion in groups)
  • Presentation of outcome from the discussions
  • Conclusion

Any PV personnel, QPPV office employees, QPPV/Deputy QPPV, PV specialists involved in activities linked to description of PV system (such as PSMF, DDPS, etc), Local Contact PV Person, Departments contributing on providing source data for description of PV system (e.g. Quality/Quality Assurance, Regulatory Affairs, etc.)

 

Participants’ experience

Basic PV knowledge

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 consists in 1 module, divided into 2 sessions (morning + afternoon):

17 May 2023 from 10 am to 12 pm CEST

17 May 2023 from 2 pm to 4 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 26/04/2023

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.

Acquista
Early bird
Acquistabile fino al 26/04/2023
€465,00
Ordinary
Acquistabile fino al 16/05/2023
€595,00
Freelance – Academy – Public Administration
Acquistabile fino al 16/05/2023
€370,00
Svuota
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
See how complex description of PV system might be
Risultato atteso
Discover how description of PV system in pharma companies might be compiled
Risultato atteso
Recognize departments involved in description of PV system
Risultato atteso
Try to compile description of PV system and decide possible strategy
<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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Description of Pharmacovigilance System