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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

Global Labeling Consultant

Opus Regulatory Inc., 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)

Panelist

Theresa Brunone, MLS, MS

GlaxoSmithKline, United States

Head-Labelling Compliance and Implementation, Global Labeling

Panelist

Dora W Cohen, MSc

PRA HS, United States

Director, Global Labeling

Panelist

Mark Collins, PhD, MBA

Opus Regulatory, United States

Principal Consultant

Panelist

Michelle L. Halliez

SANOFI, United States

Associate Vice President of Global Labeling

Panelist

Julie P. Retzinger, MBA, RN

Astellas Pharma Inc., United States

Senior Director - Global Labeling and CCDS

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Global Labeling 2016

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

Session Chair(s)

Gerrit Nijveldt, MS, MSc

Speaker(s)

Panelist

Panelist

Panelist

Panelist

Panelist

Be informed and stay engaged.