Recording Online Training: Brexit - Consequences for GMP and Supply Chain

Recording Online Training: Brexit - Consequences for GMP and Supply Chain

Costs

ECA-Member: EUR 490,--
Regular Fee: EUR 590,--
EU/GMP Inspectorates: EUR 490,--
APIC Member Discount: EUR 490,--
QP Member Discount: EUR 490,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Afshin Hosseiny, ECA Foundation, Chairman
Dr Ulrich Kissel, European QP Association, Chairman

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 exists 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. No doubt: 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.?

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 while our presenters will answers 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, Quality Assurance etc.
Technical Requirements

Programme

Background of Brexit and its Impact on Medicinal Products and APIs
Dr Afshin Hosseiny, Chairman ECA Foundation
  • Introduction – overview about the past developments
Medicinal Products and APIs from EU to UK
Dr Afshin Hosseiny, Chairman ECA Foundation
  • What are the new expectations in UK?
  • What and how importers from UK should manage these requirements

Medicinal Products and APIs from UK to EU
Dr Ulrich Kissel, Chairman European QP Association
  • What are the EMA expectations regarding imports  from UK?
  • What and how importers from UK should manage these requirements

Recording of 25 February 2021
Duration of the Recording: Appr. 2h 15 min
 

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