Affari Regolatori / Farmacovigilanza

IL sistema di vigilanza sul farmaco e la normativa per la produzione e la commercializzazione dei prodotti per la salute sono tematiche in continua evoluzione e molto complesse da gestire.

I nostri corsi hanno lo scopo di facilitare la comprensione delle normative e permettervi di restare costantemente aggiornati sugli obblighi regolatori.

Corsi in calendario

Scientific Medical Writing for Medical Devices

Mastering Key Elements of Effective Scientific Writing
dal 13/12/2023 al 13/12/2023
Online
h. 09:00 - 17:00
Barbara Grossman, Hawkeye Medical Limited Medical Writing & Consultancy, Great Britain

Kirsten Sander, ARTIMED Medical Consulting GmbH, Kassel
  • Understanding the purpose and goals of scientific writing
  • Writing for medical devices: audience and purpose
  • Systematic literature searches and writing an abstract
  • Reviewing and Editing - Proofreading tips and tools

The EU Qualified Person for Pharmacovigilance (EU QPPV)

Refresher of the duties and responsibilities of a QPPV
dal 21/02/2024 al 21/02/2024
Online
09:00 - 17:00
Dr. Christian M. Moers, Sträter Lawyers, Bonn, GERMANY

Reinhold Schilling, Wörwag Pharma GmbH & Co. KG, Boeblingen, GERMANY
  • Legal basis for the EU QPPV
  • Regulatory requirements for practice
  • Networking and integrating an EU QPPV across the company
  • Liability and legal protection

The Pharmacovigilance System Master File (PSMF) in a Global Environment

Core PSMF vs local annexes: Dos and Don'ts
dal 26/02/2024 al 26/02/2024
Online
09:00 - 17:00
Mara Dinkel, Senior Expert Pharmacovigilance, Mainz, GERMANY

Heike von Treichel, Senior Expert Pharmacovigilance, Darmstadt, GERMANY
  • Concept of a global PSMF
  • Structure and content of a core PSMF
  • Local annexes - practical hints and pitfalls
  • Effective maintenance: Impact assessment, ad-hoc updates and change control
  • QPPV oversight vs. local PV officer