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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

Brexit: Where Are We Now?

Session Chair(s)

Sandra  Kweder, MD

Sandra Kweder, MD

Principal, Drug and Biological Products

Greenleaf Health/Elilquent, United States

Brexit will impact on the established European Regulatory environment over the next decade. It may create potential new opportunities for deeper integration of the operational processes of the EU Regulatory Network, however, and may also create potential risks for regulatory business continuity that could be harmful to patients. This session will provide an overview of the current state of play of the political process from a UK as well as an EU perspective. It will seek views from important healthcare stakeholder groups, such as industry, regulators and patients on the longer term impact as well as practical aspects that need to be considered to avoid unintended consequences for EU and UK citizens while fully respecting the political decisions. Multiple stakeholder perspectives will look at the post Brexit scenario from a UK, EU and global regulatory environment view. Key stakeholders will discuss in a panel debate the impact of the expected changes on their organization and how they will capitalize on potential opportunities or mitigate potential risks to the regulatory business.

Learning Objective : Discuss the impacted changes on an organization; Describe how an organization can capitalize on potential opportunities or mitigate risks to their regulatory business.

Speaker(s)

Virginia  Acha, PhD, MSc

Panelist

Virginia Acha, PhD, MSc

Merck Sharpe & Dohme LLC , United States

AVP, Global Regulatory Policy

Jonathan  Mogford

Panelist

Jonathan Mogford

Medicines and Healthcare products Regulatory Agency (MHRA),, United Kingdom

Director of Policy

Agnès  Saint-Raymond, DrMed

Panelist

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

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