On 23 June 2016, the United Kingdom (UK) voted to leave the European Union. This came on the heels of the implementation of the new EU Clinical Trials Regulation (EU No 536/2014). A year later, the planning for Brexit is beginning, but what that departure will mean for the pharmaceutical and biotechnology industries’ development and approval processes is still unclear.
What new or different regulations may be implemented to develop new medicinal products in the UK? Will approval time slow down because of different requirements? What is the impact on pending reviews? What happens if the EMA relocates?
Most importantly, how can your organization comply with current EMA requirements and be ready for the transition?
Attend this 90-minute, interactive webinar to get an overview of the current EU clinical development environment and gain insight on the impact that Brexit will have.
At the completion of this session, attendees will be able to:
- Interpret EMA’s guidance for MAHs on what must be done to prepare for Brexit.
- Recognize changes in the regulatory requirements for submission and approval in the UK.
- Identify the impact on newly submitted MAAs’ and future approvals.
- Revise your development strategy and modify your business processes to prepare for the changes.