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Omni Shoreham Hotel

Sep 12, 2016 7:00 AM - Sep 13, 2016 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Global Labeling 2016

Essential Updates on Worldwide Regulations and Guidelines

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Session 2: The Role of the Labeling Group in a Changing Regulatory Affairs Environment

Session Chair(s)

Gerrit Nijveldt, MS, MSc

Gerrit Nijveldt, MS, MSc

Global Labeling Consultant , Opus Regulatory, United States

Labeling is described as the most important part of the dossier. The methods and concepts for labeling development vary across industry and there is a need to ensure the importance of this role is maintained. This interactive session will discuss the strategic role of the persons responsible for labeling development and the maintenance process.

Speaker(s)

Theresa Brunone, MLS, MS

Theresa Brunone, MLS, MS

Head-Labelling Compliance and Implementation, Global Labeling, GlaxoSmithKline, United States

Panelist

Dora W Cohen, MSc

Dora W Cohen, MSc

Director, Global Labeling, PRA HS, United States

Panelist

Mark Collins, PhD, MBA

Mark Collins, PhD, MBA

Principal Consultant, Opus Regulatory, United States

Panelist

Michelle L. Halliez

Associate Vice President of Global Labeling, SANOFI, United States

Panelist

Julie P. Retzinger, MBA, RN

Julie P. Retzinger, MBA, RN

Senior Director - Global Labeling and CCDS, Astellas Pharma Inc., United States

Panelist

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