Introduzione

Significant regulatory changes come along with the EU Medical Devices Regulation 2017/745 (MDR) and standards evolutions affects the labelling of medical devices.
This online course gives participants an overview on the requirements for medical devices labelling and the impact of the MDR and guideline documents on product labelling activities. The course further describes how to prepare to the new requirements from a regulatory labelling perspective.
The training will allow participants to obtain a clear understanding of the regulatory labelling requirements and will give hands on insight on how to achieve compliance.

Day 1 | 2:00 pm – 5:00 pm CET

Module 1: Overview on labelling requirements 

  • MDD vs MDR, what is new?
  • Labelling Standards and Guidelines
  • National laws

Module 2: The MDR requirements

  • MDR and transition in a nutshell
  • What is new for labelling?
  • Risks of mislabelling


Day 2 | 2:00 pm – 5:00 pm CET

Module 3: Get ready to MDR from a labelling perspective

  • General requirements Annex I MDR
  • Instructions for use (IFU)
  • Label
  • Sterile barrier
  • UDI & EUDAMED

Module 4: Symbols to be used in labelling

  • New symbols state of play
  • Symbols to be developed under MDR
  • Next steps

Module 5: Implant device and hazardous substances 

  • Implant cards
  • Hazardous substances labelling

Summary and Recommendations / Q&A

Regulatory Affairs, Labelling Department, Quality Assurance, Clinical Department, Marketing or Business Development responsible working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.

Participant experience
Knowledge of the medical device directive MDD 93/42 is an advantage. Newcomers are welcome.

The training includes knowledge transfers, interactive sessions, case studies helpful for MDR implementation.

Docente/i
Arkan Zwick
Info

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.

Online Training – 2 modules

November 18th, 2020             2:00 pm – 5:00 pm CET
November 19th, 2020             2:00 pm – 5:00 pm CET

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 720,00* (until 28 October 2020)

Ordinary: € 830,00*

Freelance – Academy – Public Administration**: € 430,00*


* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

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Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand content of the new Medical Devices Regulation and its impact on the labelling
Risultato atteso
How to achieve compliance before the end of transition period
Risultato atteso
Use practical experience from industry perspective
Risultato atteso
Industry expert overview on the new MDR requirements
Risultato atteso
Hands on experience on high risk devices and how the implement compliance in your company
Risultato atteso
Latest news from MDR developments including IDU and EUDAMED
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Labelling Requirements for Medical Devices