After Brexit: Consequences for GMP and Supply Chain - Live Online Training
Tuesday, 7 December 2021 14.00 - 17.00 h
Course No. 19168
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Afshin Hosseiny
ECA
All times mentioned are CET.
Background
The decision of the United Kingdom to leave the EU has caused a high uncertainty throughout industry in general and in the pharmaceutical industry more specifically. Since January 1st the UK has become “third country” from an EU perspective. Currently no MRA exist between UK and EU.
Up to now, there are many questions about the exact procedure and consequences. However, pharmaceutical companies must prepare to ensure supply continuity of critical medicines in UK and EU. The procedures and regulations applicable to medicinal products and APIs coming from or going to UK since 1st of January are no longer the same. Further, third countries outside the EU are impacted as well. MHRA has performed many inspections on behalf the EU outside the EU, and has issued GMP certificates.
Delays in delivery, challenges in the supply chain and even drug shortages are scenarios that are very likely to happen. Companies in EU importing medicines from UK must have provisions in place for to the QP certification of all batches received from UK. Additional questions are: How will companies approve the UK sites? Who is going to audit these sites? How do companies get their GMP certificates etc.? And finally: How do companies cope with the Northern Ireland Protocol?
The ECA and EQPA have therefore designed this online meeting to provide the latest updates from EU Commission and MHRA. Two presentations will cover the challenges: Delivery from EU to the UK and Delivery from UK to the EU. In addition plenty of time will be granted for discussion whiles our presenters will answer delegates' questions.
Target Group
The online meeting addresses all colleagues in pharmaceutical industry who have to deal with consequences from the Brexit, e.g. Quality Assurance, Qualified Persons, Regulatory Affairs, etc.
Technical Requirements
For our Live Online Training Courses and 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.
The Status Quo after Brexit – Current Requirements for Trade and Movement of Medicinal Products and APIs Dr Afshin Hosseiny, Chairman ECA Foundation
Introduction – overview about the past developments
After Brexit – What QPs Have to Consider Dr Ulrich Kissel, Chairman European QP Association
Role of the QP in the approval process
QP declaration
Clinical trial material
Specific Challenges for Manufacturers of Medicinal Products and APIs – Examples and Case Studies Dr Ulrich Kissel, Chairman European QP Association, Dr Afshin Hosseiny, Chairman ECA Foundation
What are the EMA expectations regarding imports from UK?
What and how importers from UK should manage these requirements?
Specific challenges related to the NI protocol
Questions and Answers Session
Participants are invited to ask questions.
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Seminar Programme as PDF