
Dispositivi Medici
Quello dei Dispositivi Medici è un settore che, negli ultimi anni, ha subito una vera e propria rivoluzione, soprattutto dal punto di vista delle norme che lo regolano.
Il panorama dei corsi che eroghiamo in tale area abbraccia
tutto il ciclo di vita di un Dispositivo Medico, dalla classificazione del
prodotto, alla costruzione del file tecnico, fino alla pubblicità, passando
attraverso indagini cliniche, vigilanza e gestione del rischio.
Corsi in calendario

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?

Masterclass China
Medical Device Marketing Authorisation for Advanced
dal 05/12/2023 al 06/12/2023
Online
05/12/2023 h. 09:00 - 12:00
06/12/2023 h. 09:00 - 12:00
06/12/2023 h. 09:00 - 12:00
Dipl.-Ing. Stefan Fischer, Cisema (Hong Kong) Limited
BA/LLB, RAC Hamish King, Cisema (Hong Kong) Limited
Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!
Topics
- Update your regulatory knowledge
- Pre-Market Registration (PMR): Minimalise your efforts and costs
- Acceptance of European registration tests
- Clinical pathways: From feasibility study report to a clinical trial
- Perfect your cooperation with your NMPA legal agent
- Chinese IFU and label