About

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

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.

Lecturers
Arkan Zwick
Info

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven 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

DAY 1 | 18 November 2021 from 09:30 am to 12:30 pm CET

DAY 2 | 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.

Book Now
Early Bird
Available until 21/10/2021
660,00
Ordinary
Available until 18/11/2021
850,00
Freelance – Academy – Public Administration
Available until 18/11/2021
430,00
Clear

Printable Version
At the end of the training, you will be able to
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>