Biopharmaceuticals (includes Biologics)
The years 2016-2019 have been characterised by protracted negotiations and prolonged uncertainty over the UK’s future relationship with the EU following Brexit. The pharmaceutical sector, one of the largest industries in the UK and EU, patiently awaited the outcome of the negotiations, whilst preparing for the worst case ‘no deal’ scenario. With the withdrawal negotiations concluded and the UK formally exiting from the EU, the fog of uncertainty has begun to recede, allowing companies to better commit to medium to long term projects and regulatory strategy.
This session provides key considerations for Brexit readiness in a time of uncertainty and will dissect what the impact is on regulatory procedures in the UK and EU, supply chains, GxP requirements, global expansion strategies, and whether there is any common ground between the UK and EU which will enable regulatory efficiencies. The session will finally evaluate the UK’s planned novel national regulatory offerings and how companies can best use them, which can be applied as part of a company’s overall regulatory strategy for Europe.