Brexit – Preparing for the end of the transition period and beyond

20 October 2020 | 3 - 4PM CEST


agenda

What to expect.

On 20 October our PharmaLex Quality, Regulatory and Pharmacovigilance industry experts Charley Maxwell, Graham Donaldson and Martyn Critchley will be delivering a complimentary webinar on Brexit and getting ready for the end of the transition period on 01 January 2021.

There has been a lot of speculation in recent months on the ongoing Brexit negotiations and the implications that this will have on the pharmaceutical supply chain as well as the regulatory and pharmacovigilance framework.  This will impact manufacturers and distributors that have their products registered in the UK and EU markets and who need them to transit the UK/EU border.   It is useful therefore that both the EMA and MHRA have published guidance in the past few months that sets out their position and allows industry to plan for the eventual outcomes.

This webinar will focus primarily on Pharmaceutical products being manufactured and released as well as distribution across the EU and into the UK. 


speakers

A full hour of inspirational speakers.

 

 

 

Martyn Critchley

Head of Medical Affairs, PharmaLex

Martyn is a Senior Director at PharmaLex UK and has over 30 years experience in the Pharmaceutical industry including 12 years in consultancy.  Martyn is responsible for PharmaLex UK’s pharmacovigilance operations and is part of the global Pharmacovigilance, Epidemiology and Risk Management team within PharmaLex.

 

Graham Donaldson

Associate Director, Regulatory Affairs, PharmaLex

Graham is a Director, Regulatory Affairs at PharmaLex UK. Graham has over 15 years experience in pharmaceutical regulatory consultancy. Graham leads PharmaLex’s UK and Ireland Regulatory Centre of Excellence service delivery area. He advises a wide range of companies about their regulatory activities in the UK and Ireland. 

 

Charley Maxwell

Director QMC, PharmaLex

Charley has recently joined Pharmalex as Director QMC and Senior Consultant.  He joins us with 20 years’ experience working in industry in Pharmaceutical and Device manufacturing and importation.
His background is B.Sc. In Biochemistry and M.Sc. In Pharmaceutical Manufacturing Technology and he has operated as a QP in Ireland since 2018 for sterile and non-sterile manufacture and third country Importation.


Why Attend

PharmaLex experts will provide updates for our UK, EU and international audiences answering queries on the most recent updates and final preparations for the end of the Brexit transition period. Following recent intense negotiations, the EMA and MHRA have recently published revised guidance setting out their position on preparing for the end of the transition period. 

We have analyzed the impact for the Pharmaceutical industry and have prepared this webinar to discuss the next steps for:

  •  Import-export and Wholesale distribution.
  •  The revised Regulatory framework and associated timelines.
  •  How Pharmacovigilance safety information and ICSRs will be handled.

Register

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