Post Brexit PV readiness- for US and International pharma /biotech companies based outside of EU
Instructor : Milind Nadgouda
Jun 19, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes
On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), a process known as 'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure that it can continue to deliver on its mission and protect public and animal health after the UK leaves the EU.
The exercise of Brexit has key milestones that have already been completed and a few significant one to follow. Brexit will have a bearing on the industry owing to change in legislation and regulatory compliance. A substantial impact on the pharmaceutical/medical device industry is expected and the industry is gearing up for these. European Medicines Agency has specific expectations for Pharmacovigilance processes and reporting; Brexit will influence these.
If you are a PV team member from a Pharmaceutical/Biotech company that is:
- A clinical stage company
- A MAH with one or more products registered in EU
- A MAH holder with one or more products registered in UK
- A clinical stage company with a MAA in process in EU
- What has occurred since invoking Article 50 on the 29 Mar 2017?
- What needs to happen after Brexit occurs?
- The current scenarios of Hard Brexit v Soft Brexit
- Brexit Deal Agreement - How key is it for safety reporting?
- Brexit Deal Disagreement - Industry readiness and will it be status Quo?
- Transition Period - what can/can't be done and what must be done?
- Insights on what to expect post Brexit.
- Help strategize and provide some insight on what areas to focus.
Who will benefit:
- Regulatory Professionals
- Quality Professionals
- C-level Executives
- Small business owners
- IT VPs