After Brexit: Consequences for GMP and Supply Chain - Online Training Recording
Course No. 19168A
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Afshin Hosseiny
ECA
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 Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
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
Recording from 7 December 2021 Duration of Recording: 2h 35min
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