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

ExpertFORUM Labelling

Online conference on digital, patient-friendly and safety labelling
dal 16/10/2023 al 17/10/2023
16/10/2023 h: 09:00 - 16:30
17/10/2023 h: 09:00 - 13:00
Dr. Peter Bachmann, -requested- Senior Expert Regulatory Affairs, Bonn

Kim Sherw ood, Medical Products Agency (MPA), Uppsala, SWEDEN

Nina Malvik, Norwegian Medicines Agency, Oslo, NORWAY

Dr. Rüdiger Faust, UCB BIOSCIENCES GmbH, Monheim, GERMANY

Dr. Jörg Fuchs, PAINT-Consult®, Jena, GERMANY

Dr. Thomas Grüger, -requested- Senior Expert Pharmacovigilance, Bonn, GERMANY

Olga Kolcak, Bayer Consumer Care AG, Basel, SWITZERLAND

Robert Begnett, Kyow a Kirin International plc, Marlow , GREAT BRITAIN
  • Impact of EU pharmaceutical legislation on drug labelling
  • Patient information in the digital age: Latest achievements in ePI and the use of AI
  • How to achieve patient-friendly package leaflets
  • Labelling compliance during product life cycle: National and global perspectives
  • Pharmacovigilance: Current requirements and trends for labelling and educational material

Crash Course: Medical Device Regulation

Insights into the applicability and general structure of the MDR
dal 19/10/2023 al 19/10/2023
h. 09:00 - 17:00
Prof. Dr. Stephen Gilbert, Technische Universität Dresden, Dresden, Germany

ESQ., M.L.B., M.H.A Robert Lindner, Ada Health GmbH, Berlin, Germany

- Overview of the Medical Device Regulation
- Responsibilities of the various parties
- Quality management system requirements (ISO 13485)
- General safety and performance requirements (GSPR)
- Technical documentation and CE certification
- Post-market surveillance: vigilance, PMCF and reporting

Masterclass China

Medical Device Marketing Authorisation for Advanced
dal 05/12/2023 al 06/12/2023
05/12/2023 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

Dipl. BWL Guo Ning, Cisema Beijing Consulting Ltd.
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!

  • 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

EU HTA: National preparation in France, Italy, Spain and UK

Part 3
dal 13/12/2023 al 13/12/2023
09:00 - 13:00
Dr. Thomas Ecker, Ecker + Ecker GmbH, Hamburg

Alain Estival, Cemka, France

Christian Hill, MAP Patient Access, Cambridge, GREAT BRITAIN

Luis Lizán, Outcomes 10, Spain

Mariangela Prada, Intexo Società Benefit Srl
  • EU HTA: State of preparation and influence from a UK perspective
  • EU HTA: Alignment with national HTA processes in France, Spain and Italy
  • National scientific consultation on the HTA