Important GMP Regulatory Intelligence Digest for 2022/23

Course Overview

As a busy Quality Professional, staying updated on important regulatory changes may be difficult.

2022 and 2023 bring many impending changes to GMP chapters, annexes, and new regulations to replace older European directives. Additionally, Mutual Recognition Agreements and Brexit carry new challenges you must prepare for.

This webinar will make it easier for you to catch up on all the important regulatory intelligence over the past year and help plan for implementation into routine operations in 2023.

We will cover the most significant updated and new guidelines in the past 12 months, including the following:

• The introduction of Eudralex Vol 4, Annex 21
• Updates to Eudralex Vol 4, Annex 1
• The coming into force of the Clinical Trials Regulation (Regulation (EU) No 536/2014) and associated delegated regulation and supporting guidelines.
• The coming into force of Regulation (EU) 2019/6 on Veterinary Medicinal Products
• The latest intelligence on the impact of Brexit, NI Protocol, and NI Protocol Bill.