Attestato di partecipazione
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.
The course will also cover the new symbols of ISO 15223 and the latest 2021 version of ISO 20417 and its correlation to the MDR requirements.
DAY 1
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
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
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
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.
Online Training – 2 modules
18 November 2021 from 09:30 am to 12:30 pm CET
19 November 2021 from 09:30 am to 12:30 pm CET
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
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: € 660,00* (until 21 October 2021)
Ordinary: € 850,00*
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: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.