
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

CMC Management in Regulatory Affairs
Quality data for marketing authorisation in Europe
dal 24/10/2023 al 25/10/2023
Online
24/10/2023 h. 09:00 - 17:00
25/10/2023 h. 09:00 - 17:00
25/10/2023 h. 09:00 - 17:00
Dr. Margit Schnee, Vifor Pharma
André Mota, ASPHALION S.L., Madrid Office, Spain
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
Topics
- Regulatory requirements in the EU and the ICH region
- Essential quality data for marketing authorisation
- CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary
- Management of post-approval changes
- Classification of quality related variations

CMC for Biologicals
With a focus on proteins
dal 16/11/2023 al 16/11/2023
Online
h. 09:00 - 17:30
Dr. Steffen Groß, Paul-Ehrlich-Institut (PEI), Langen
Dr. Michael Jandke, Miltenyi Biomedicine, Bergisch Gladbach
Get your know-how on creating and maintaining quality data for biotech products in our online training.
Topics
- Regulatory framework: ICH guidelines
- Essential data for biologics for Module 3
- Challenges in Module 3: Focus on antibodies, immunoglobulins and recombinant proteins
- Comparability requirements for changes
- Critical data: Which data must be included in the dossier, which not?