Webinar: Post-Brexit Solutions

 
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Post-Brexit Solutions: The Northern Ireland Protocol and the opportunity that exists to create a robust Clinical Supply Chain strategy

Brexit has introduced new levels of uncertainty for the life sciences sector. As we move towards the end of the transition period on 31st December 2020, uncertainty still exists in the field of clinical trials in terms of market access and QP release between EU27 and UK. The need for clinical trial sponsors to put in place robust strategies to ensure continuity of supply, compliantly and cost-effectively, post-transition is paramount.

This webinar will explore the possible scenarios of a post-Brexit landscape, the impact on clinical supply chains, the core strategies available to Sponsors to ensure robust logistics and QP release while maintaining compliant, cost-effective and patient-centric operations through the transition period and beyond. It will also explain the nuances of the NI Protocol and how it can translate into a commercial advantage for sponsors and how it will be ‘business as usual’ for sponsors given the special status for Northern Ireland.

Participants will gain insights into:

  • Understanding of the NI Protocol in the field of clinical trials after the transition period and the immediate benefits to sponsors running clinical studies in the UK, EU or both
  • Detail on the free movement and transfer of clinical supplies in and out of Northern Ireland to both EU and UK destinations
  • Assurance that the NI Protocol offers unfettered access from Northern Ireland to UK and EU27 markets post transition
  • Guidance in relation to QP release and Logistics services Brexit and beyond
  • Business as usual for Rest of World shipments with no impact to import and export
  • Up to date information on the political and industry positions and guidance in relation to the transition period and beyond for the life sciences sector.

Speakers

Ivan Waide

Corporate Counsel, Almac Group
Ivan Waide graduated with a Bachelor of Laws (LLB). Prior to joining Almac in 2016, Ivan was a partner at a leading Irish law firm, and before that a London-based corporate lawyer at a UK and US law firm. Ivan’s experience encompasses a wide range of legal areas, including commercial law, contracts & the supply of goods and services.

Ivan has been a member of Almac Group’s Brexit Steering Group, which was established in July 2016, following the UK’s referendum on EU membership.

Caitriona Lenagh

QP Service Manager | Qualified Person
Caitriona Lenagh joined Almac in 2009 and has first-hand experience in all QP requirements in the world of Global Clinical Trials. She has worked with global teams, educating and mentoring them in the requirements of EU legislation, particularly the roles and responsibilities of the Qualified Person.

She has extensive experience in a number of dosage forms and has performed audits of manufacturing, testing and packaging sites throughout the world, imparting knowledge on the regulatory requirements and industry expectations.

Sharon Courtney

Logistics Services Manager
Sharon is an International Logistics Specialist having worked for 18 years in Clinical Supply Chain. She has expert knowledge in a number of key areas within the end to end supply chain process including management and control of temperature sensitive shipments; risk mitigation (identifying and managing risk); developing and managing robust relationships with transport partners; chain of custody responsibilities; active and passive shipping solutions and import/export country knowledge.

Sharon has consistently delivered reliable and validated logistics solutions for customers based on her experience of establishing numerous international logistics models over the years. Sharon is passionate about providing excellent customer service in the area of logistics and this is demonstrated in her understanding of every role within the end to end supply chain process.

She has first-hand knowledge of working with customers, external organizations and the appropriate departments within Almac to deliver well established logistics solutions in the Pharma industry. Sharon has travelled widely with her work and has been instrumental in the development of the logistics service provided by Almac.

Mark Gribben

Key Account Group Manager
Mark Gribben is the Key Account Group Manager at Almac Clinical Services in Craigavon, UK. Mark leads a global team to support the needs of Almac’s key and strategic clients from a commercial and operational perspective. Mark works closely with colleagues across Almac’s facilities in the EU, US and APAC to provide innovative clinical supply solutions to many of Almac’s largest clients on a global basis.

Throughout the Brexit negotiation period Mark has been responsible for ensuring Almac’s global client base have been kept informed of the Almac solution, advantages, and laterally the impact of the Ireland / Northern Ireland Protocol.

He has over 15 years Business Development experience and was educated at Queen Margaret University, Edinburgh and holds a BA (Hons) in Business Management.

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