Introduzione

The EU Regulation on Medical Devices 2017/745 (MDR) significantly changed the landscape for the medical device industry. The Regulation introduced novel requirements in key areas such as stronger Notified Body Oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance. The Regulation also introduced a responsible person for regulatory compliance for manufacturers and additional duties for importers and distributors.

The MDR set requirements for consultation procedures and scrutiny for high-risk devices. As the transition is coming to an end now is the right moment to get insights on how to deal with the requirements, understand how to prepare for the end of transition period and discuss latest updates and practical solutions.

The seminar allows participants to get a clear picture on the Regulation, understand transition timelines and ensure compliance to the new landscape.
The seminar includes knowledge transfers, interactive sessions, case studies and practical hints helpful for MDR implementation.

MODULE 1
Module 1: Understanding the MDR 2017/745

  • Overview
  • MDR vs. MDD
  • Key changes
  • Opportunities and threats

Module 2: Transition and System readiness

  • Transition for industry & notified bodies.
  • State of play of notified body designations
  • System readiness. Solutions for end of transition.
  • Recommendations to Industry – best practices. Group discussion.

Module 3: Walkthrough the MDR

  • Overview on Preamble, Chapters, Annexes.
  • State of play Guidance and Implementation regulations
  • Key changes in the Regulation.
  • What is new for combination products.

Module 4: Classification and conformity assessment

  • Classification rules and conformity assessment procedures.
  • General and special conformity assessment procedures.
  • Role of EMA and expert panels.

Recap day one / Q&A

MODULE 2
Module 1: Person responsible for regulatory compliance

  • Qualification and Responsibilities
  • How to implement
  • Liability and risk mitigation measures

Module 2: Technical Documentation

  • Content of Technical Documentation – what is new.
  • General Safety and Performance Requirements – what is new.
  • Experiences from MDR certification and how to meet notified body expectations. Group discussion.

Module 3: Post market requirements

  • Overview on post market requirements and vigilance
  • Periodic Safety Update Reports PSURS
  • Summary of Safety and clinical Performance SSCP

Module 4: Clinical data and Claims

  • What is sufficient clinical data?
  • Claims management
  • Strategies how to address gaps in pre-clinical and clinical modules.

Recap day two / Q&A

  • QA Managers
  • Regulatory Affairs Managers
  • Clinical Trail Managers
  • R&D Managers
  • Company CEO / CTO
  • Person Responsible for Regulatory Compliance (PRRC)

Attendees’ experience
Basic Knowledge of device regulations is an advantage.

The seminar will consist in several modules including lectures, cases studies and interactive sessions (Q&A).

Docente/i
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

14 June 2023       9:30 am – 1:30 pm CEST
15 June 2023       9:30 am – 1:30 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.

Early Bird: € 880,00* (until 24 May 2023)

Ordinary: € 1.070,00*

Freelance – Academy – Public Administration**: € 572,00*

* 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.

Acquista
Early bird
Acquistabile fino al 24/05/2023
880,00
Ordinaria
Acquistabile fino al 13/06/2023
1.070,00
Freelance - Accademia - Pubblica Amministrazione
Acquistabile fino al 13/06/2023
572,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the content of the Regulation and latest developments
Risultato atteso
Understand the impact on your organization and your products
Risultato atteso
Implement best practice examples on how manage end of transition

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