The United Kingdom’s decision to leave the EU will present significant implications to the biopharmaceutical industry. While the exact nature of the future UK relationship with the European Medicines Agency (EMA) is still unknown, the industry must prepare for the UK taking a ‘hard BREXIT’ approach and effectively becoming a third country by 30th March 2019. We understand our clients’ concerns – the need to ensure that patients have an uninterrupted supply of the medicines that they need – to ensure continuity of R&D and business operations – and to ensure compliance in an evolving regulatory landscape.
PAREXEL has established an internal task force to generate action plans based on various scenarios and ensure our teams are prepared for whatever agreements are finally signed and actions are taken in areas including: clinical study continuity, regulatory, technology updates, insurance, import/export, staff/payments, IMP and QP, and site and client contracts. Our Project Leaders will be responsible for leading client teams through project risk assessment and the action planning needed to assure smooth project delivery during this period of transition.
PAREXEL was founded nearly 37 years ago to help clients conduct clinical trials that were becoming increasingly global in nature. Our mission is to ensure that despite the disruptive landscape, our client’s journey to patients in need is uninterrupted. Through our connected journey we can bring together the technology, processes and expertise to help companies navigate through the regulatory, logistics, development and commercialization implications of BREXIT, with services including:
Over 1000 regulatory experts including >50 former regulators. We can support companies worldwide develop a comprehensive regulatory strategy for various BREXIT scenarios.
A ‘BREXIT-Ready’ global clinical trial supplies distribution network with QP release and distribution from an EU-based hub.
QPPVs (Qualified Persons for Pharmacovigilance) located across our EU offices.
We can support clients with the provision of a non-UK based QPPV, and provide guidance and practical support for risk management and pharmacovigilance post-BREXIT.
Market access and commercialization experts that can help companies mitigate commercial risks posed by BREXIT.