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.
Revising supply chain strategies to ensure risk mitigation, business continuity and minimisation of patient impact have already been a focus, as well as identifying the additional regulatory challenges on drug distribution to and from the EU, once the UK leaves the single market. Many sponsors with manufacturing operations in the UK or who utilise the services of UK based CDMO’s to export into the EU are aware that operating clinical supply chains during the transition period and into a post-Brexit landscape will incur additional complexities.
However, provisions within the Withdrawal Agreement, in the form of the Ireland/Northern Ireland Protocol (“the NI Protocol”), have made it possible for sponsors to maintain unfettered access and seamless regulatory movement from Northern Ireland into EU and UK markets, while obtaining a clear and stable path forward that removes all potential risk and uncertainty from the equation. The NI Protocol places Northern Ireland in a unique and advantageous position in being able to offer clinical sponsors a ‘business as usual’ opportunity. Post transition, final QP release of clinical trial supply material by a Northern Ireland QP will be recognised by both UK and EU regulatory agencies. In addition, the free movement and transfer of clinical supplies will continue in and out of Northern Ireland to both EU and UK markets. This move provides clinical sponsors with the confidence and reassurance they have been seeking regarding continuity of supply to their patients.
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.
Caitriona Lenagh, QP Service Manager | Qualified Person, Almac
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.Message Presenter
Sharon Courtney, Logistics Services Manager, Almac
Sharon Courtney 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.
Sharon 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. She has travelled widely with her work and has been instrumental in the development of the logistics service provided by Almac.Message Presenter
Mark Gribben, Key Account Group Manager, Almac
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 latterly 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.Message Presenter
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.Message Presenter
Who Should Attend?
This webinar will be of interest to members of the following industries, in the following job titles:
- Pharmaceutical Industry
- Biotechnology Industry
- Manager/Director of Clinical Research
- Manager/Director of Supply Chain
- Manager/Director of Operations
- Manager/Director of Logistics
What You Will Learn
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.
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately owned organization that has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.
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