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ONLINE TRAINING: Labelling Requirements for Medical Devices

Understanding the regulatory labelling requirements for medical devices in the context of the MDR 2017/745

Date

18 and 19 November 2020

Location

Online

Language

English

ONLINE TRAINING: Labelling Requirements for Medical Devices

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 CEST

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 CEST

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


Course Language

The online training will be in English
Arkan Zwick
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.

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.

Online Interactive Training

Online Training - 2 modules

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

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.

Certificate of attendance

Early Bird: € 720,00* until October 28th, 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: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

830.00 €

Early Bird

Wednesday, October 28, 2020

720.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules, 3 hours each

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Understand content of the new Medical Devices Regulation and its impact on the labelling

  • How to achieve compliance before the end of transition period

  • Use practical experience from industry perspective

  • Industry expert overview on the new MDR requirements

  • Hands on experience on high risk devices and how the implement compliance in your company

  • Latest news from MDR developments including IDU and EUDAMED

Participants' Feedbacks

International and multidisciplinary profile of participants, which enriches the training

Availability and competence of the lecturer

Variety of topics covered, which have been adapted to the different needs of the participants

Good atmosphere in the group and interaction with the lecturers (really available for all questions)

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

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ONLINE TRAINING: Labelling Requirements for Medical Devices

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.