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Tuesday, June 20 • 4:00pm - 5:15pm
#279: Brexit: Where Are We Now?

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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

Chair

Sandra L. Kweder

Speaker

Panelist
Virginia Lee Acha, PhD, MSc

Panelist
Jonathan Mogford

Panelist
Agnès Saint-Raymond, MD



Speakers
avatar for Virginia Acha

Virginia Acha

Executive Director, Research, Medical and Innovation, Association of the British Pharmaceutical Industry (ABPI)
Virginia (Ginny) has worked in private sector and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined ABPI in 2015 to lead policy for research, medical and innovation to deliver better... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Dr. Sandra L. Kweder was named Deputy Director of the Europe Office in the FDA Office of International Programs (OIP) in March 2016. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs (OND) in FDA’s Center for Drug Evaluation & Research (CDER... Read More →
avatar for Jonathan Mogford

Jonathan Mogford

Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
MD, Paediatrician. Chef de Clinique in Paediatrics@Necker-Enfants-Malades Hospital (Paris 1985-90). Pharma industry 1990-95. French Medicines Agency (ANSM) 1995-99 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. EMA 2000-current. EMA Head of Paediatric Medicines, Orphan Medicines... Read More →


Tuesday June 20, 2017 4:00pm - 5:15pm
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics Global Regulatory,Public Policy
  • Credit Type CME, IACET, RN
  • Tags Forum