

WHEN
Thursday, 10th September
from 15:00 to 16:00 CET
WHEN
Thursday, 10th September
from 15:00 to 16:00 CET
JOIN THE WEBINAR!
JOIN THE WEBINAR!
CONNECTION
You will receive all the details by e-mail
CONNECTION
You will receive all the details by e-mail


Join this webinar to learn more about the Person Responsible for Regulatory Compliance (PRRC), as required by the MDR 745/1017 and IVDR 746/2017, and how to structure your quality agreements with critical suppliers, such as your distributors & importers.
Discover & Learn:
MDR/IVDR regulations require manufacturers to put in place quality agreements with distributors & importers and to designate a Person Responsible for Regulatory Compliance (PRRC) within their organization, or outsourced under certain conditions.
In this webinar, we will provide an overview on:
- The Person Responsible for Regulatory Compliance
​
​
​
​
- Quality Agreements with Distributors & Agreements
At the end of the webinar, we will make available special templates that will guide you on how to design a PRRC and to define its job description within your organization. We will also make available a template for quality agreements
Join this webinar to learn more about the Person Responsible for Regulatory Compliance (PRRC), as required by the MDR 745/1017 and IVDR 746/2017, and how to structure your quality agreements with critical suppliers, such as your distributors & importers.
Discover & Learn:
MDR/IVDR regulations require manufacturers to put in place quality agreements with distributors & importers and to designate a Person Responsible for Regulatory Compliance (PRRC) within their organization, or outsourced under certain conditions.
In this webinar, we will provide an overview on:
- The Person Responsible for Regulatory Compliance
​
​
​
​
- Quality Agreements with Distributors & Agreements
At the end of the webinar, we will make available special templates that will guide you on how to design a PRRC and to define its job description within your organization. We will also make available a template for quality agreements
PRRC & QA WEBINAR
PRRC & QA WEBINAR
FREE!
FREE!
All Right Reserved 2020 © Obelis Group
All Right Reserved 2020 © Obelis Group
Stay in touch
Stay in touch
Interested in other webinars? Let us know!
Interested in other webinars? Let us know!
Complying with the EU Market Regulations can be a daunting task to undertake on your own. Make sure you get all the information you need.
We bring our experience and knowledge in the medical regulatory field, so don't miss the webinar!
Complying with the EU Market Regulations can be a daunting task to undertake on your own. Make sure you get all the information you need.
We bring our experience and knowledge in the medical regulatory field, so don't miss the webinar!
31 YEARS OF QUALITY
SERVICE IN REGULATORY AFFAIRS
31 YEARS OF QUALITY
SERVICE IN REGULATORY AFFAIRS

Webinar: Person Responsible for Regulatory Compliance - MDR/IVDR
Webinar: Person Responsible for Regulatory Compliance - MDR/IVDR
SPEAKERS
SPEAKERS
Ajda Mihelcic
Deputy Manager
Publishing Department
Ajda Mihelcic
Deputy Manager
Publishing Department
10 September, 15:00 CET
Save the Date!
10 September, 15:00 CET
Save the Date!


Roland Gerard
Manager
Regulatory Affairs Department
Roland Gerard
Manager
Regulatory Affairs Department
PRRC Job Description
PRRC Job Description
WE WILL BE COVERING:
WE WILL BE COVERING:

Quality Agreements
Quality Agreements


- Job Description
- Designation method
- Tasks and responsibilities
- Cooperation between PRRCs (manufacturer & EAR)
- Job Description
- Designation method
- Tasks and responsibilities
- Cooperation between PRRCs (manufacturer & EAR)
- Job Description
- Designation method
- Tasks and responsabilities
- Cooperation between PRRCs (manufacturer & EAR)
- Job Description
- Designation method
- Tasks and responsabilities
- Cooperation between PRRCs (manufacturer & EAR)