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.
TORONTO (PRWEB) September 18, 2020
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.
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