About

Since the publication of the revised EU regulatory framework for medical devices (MDR 2017/745 and IVDR 2017/746), many innovations must be implemented to ensure compliance with the MDR/IVDR environment. One of them is the Person Responsible for Regulatory Compliance (PRRC).
This responsible person must comply with specific qualifications and assume essential tasks in the manufacturer's organisation.

In this course, the background of the revised regulations and the tasks and responsibilities of the PRRC are explained in detail. It could be difficult for a single person to fulfil all of them.
The legislation allows the tasks to be distributed among more than one person.

But how must responsibilities be defined, and how can the PRRC ensure oversight of the most critical processes? What are the internal interfaces, and what should be prepared for this new role?

The course is dedicated exactly to these questions.
It shows ways and possibilities how to make the necessary preparation and will give you practical tips to meet the challenges and find out more about the most important aspects for the daily practice.

MODULE 1
The Regulation on Medical Devices

  • Introduction, regulation overview and impact on the industry
  • Transition period
  • Latest updates and MDCG Guidance
  • Industry experience in MDR preparation

Legal requirements for the PRRC

  • Legal framework for the PRRC
  • Who needs a PRRC, and when?
  • Organizational integration and hierarchy
  • Qualifications, tasks and responsibilities
  • Options for how to implement

Liability risks for the PRRC

  • Fundamentals of civil, criminal, labor and medical device law
  • Liability of the company for damage claim
  • Individual liability
  • Risk mitigation measures

MODULE 2
Tasks of the responsible person, what is new in the MDR

  • Conformity check of products and release
  • Technical documentation and EU declaration of conformity
  • Technical documentation on post market
  • Reporting obligations
  • Declaration for investigational products
  • PRRC oversight and practical challenges – the release matrix

PRRC interfaces – Examples for processes / SOPs

  • Marketing/Sales. Impact of Art 7. Release of advertisement materials
  • R&D process: is the PRRC in the core team? How to insure compliance at an early stage?
  • Production/Quality – OOS, CAPA processes
  • Clinical Evaluation: Limitations to equivalency, special procedures for thigh risk devices, SSCP and the role of the PRRC
  • The regulatory survey process and Conformity Assessment processes and the involvement of the PRRC
  • Change control and life cycle, Reportable changes and significant changes (Art 120), PSUR processes
  • Vigilance and trend reporting Art 88 Challenge.

The seminar is first aimed at qualified and responsible persons in medical devices and pharmaceutical companies and participants who have been aspiring to these tasks. The seminar is also valuable for all staff having interference with the PRRC to improve their understanding of its role and responsibilities.
Employees of the following department’s profit from our seminar:

  • Vigilance & Regulatory Affairs
  • Quality Assurance & Quality Control
  • Management and Legal

Participant experience
Experience with medical devices regulatory processes in Europe may be helpful.

The training will consist of lectures, case studies discussion and Q&A sessions.

Lecturers
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

MODULE 1 | 16 May 2024    9:30 am – 12:30 pm CEST
MODULE 2 | 17 May 2024    9:30 am – 12:30 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: € 680,00* (until 26 April 2024)

Ordinary: € 875,00*

Freelance – Individual – Academy – Public Administration**: € 445,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – 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.

Ilaria Butta
Ilaria Butta
Events & Training Manager
Printable Version
At the end of the training, you will be able to
Risultato atteso
Appropriately understand and define the PRRC responsibilities
Risultato atteso
Know what the internal interfaces are and what should be prepared for this new role

<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>