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.
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
- 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
- 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
- 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