Post Brexit PV readiness- for US and International pharma /biotech companies based outside of EU

Product Id : FDA231
Instructor : Milind Nadgouda
Jun 19, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

Description

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

Session Highlights:

  • 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
  • GxP
  • Consultants
  • IT VPs
Speaker Profile:

Milind Nadgouda is a seasoned quality and regulatory professional with 19 years of industry experience. He is the Co- founder and Director at RiverArk Limited; a Quality Consultancy providing services in GxP space. His core areas of specialisation are Risk Strategy (Identification; Assessment; Rating; Prevention and Mitigation); Regulatory Agency Inspection Readiness and Quality Management System GAP analysis. Milind has worked on different types of quality projects with methodologies such Six Sigma; Kaizen and Lean. His expertise on quality strategy and regulatory compliance has been derived from hands on real world experience. So far in his career Milind has been in the frontline during GxP inspections and has on several occasions been in the back room supporting the team for inspections. AstraZeneca, Bristol Myers Squibb, Ranbaxy and Eli Lilly are few of the companies Milind has worked at and consulted. He sees himself as a problem solver and a solution provider.


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