David Cockburn, European Qualified Person Association (EQPA)
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.
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.
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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