Sprecher
David Cockburn, European Qualified Person Association (EQPA)
Hintergrund
After long discussions, the European Medicines Agency EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019).
Business models have been changing over the years and many companies hold a Marketing Authorisation, but not a Manufacturing Authorisation. For some it is not easy to understand how Good Manufacturing Practice (GMP) applies to their overall responsibilities for the product. This can be difficult to comprehend when reading the GMP guide or the applicable legislation. The new Reflection Paper is intended to provide clarity.
On behalf of the European QP Association (EQPA), David Cockburn commented EMA’s Reflection Paper. Comments were officially sent to EMA as an EQPA Feedback.
Business models have been changing over the years and many companies hold a Marketing Authorisation, but not a Manufacturing Authorisation. For some it is not easy to understand how Good Manufacturing Practice (GMP) applies to their overall responsibilities for the product. This can be difficult to comprehend when reading the GMP guide or the applicable legislation. The new Reflection Paper is intended to provide clarity.
On behalf of the European QP Association (EQPA), David Cockburn commented EMA’s Reflection Paper. Comments were officially sent to EMA as an EQPA Feedback.
Zielgruppe
The webinar is aimed at executives and employees from Marketing Authorisation Holders (MAHs) and Manufacturing Authorisation Holders who want to gain a better understanding of the reflection paper and its possible consequences.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
The goal of this webinar is to give attendees a comprehensive yet compact overview of the current reflection paper and have a closer view on:
- What is the issue?
- What is a Reflection Paper?
- What are the main messages?
- What views has EQPA conveyed in its response to the Paper?
- What happens next
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