Pharmacovigilance Audits and Inspections Training Course 2019

Tutors

Pharmacovigilance professionals, one former inspector and one former EU regulator will be lecturing this training course. All tutors have many years of experience in auditing and advising to companies prior to start of inspections.

  • Jana Hyankova, MD                                                                                                                                      EU QPPV and Head of Quality Systems Unit at PrimeVigilance, 15 years in Pharma Industry 
  • Zuzana Chomatova, MSc                                                                                                                          Pharmacovigilance Auditor at PrimeVigilance, 9 year of experience as Pharmacovigilance Inspector at Czech Drug Agency (SUKL), Former Member of Pharmacovigilance Inspectors Working Group at EMA (2010-2018)
  • Martina Vlkova, PhD                                                                                                                                    Pharmacovigilance Auditor at Adamas
  • Jana Mlada, MD                                                                                                                                            Pharmacovigilance Auditor and EU QPPV at PrimeVigilance, Former Head of Registration Department at Czech Drug Agency (in total 16 years at SUKL), Former PRAC Member at EMA
  • Lucia Matejkinova, MSc                                                                                                                             Associate Director, Pharmacovigilance, Quality Systems Unit, EU  QPPV at PrimeVigilance Prague, 10 years in Pharma Industry 
  • Andreea Salagean                                                                                                                                        Pharmacovigilance Auditor and PSMF Expert at PrimeVigilance 
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