Post-Brexit Solutions: The Northern Ireland Protocol and the opportunity that exists to create a robust clinical supply chain Upcoming Webinar hosted by Xtalks

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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 working with a CMO in Northern Ireland, given its special status.

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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.

Join industry experts from Almac for an informative live session taking place on Monday, October 19, 2020 at 10am EDT (3pm BST/UK).

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 to patients, 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.

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 during 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

For more information or to register for this event, visit Post-Brexit Solutions: The Northern Ireland Protocol and the Opportunity That Exists to Create A Robust Clinical Supply Chain.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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