Webinar on Strategies for Global Labeling Management in Changing Reg Environment

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(No Transcript)
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Overview
If you are part of Regulatory - Labeling team in
your company, you should not miss this Webinar.
As you are constantly working to coordinate a
more robust end-to-end labeling process, and
trying to get yourself up to speed on the newest
emerging regulations / guidances from FDA and
EMA, MakroCare brings you this opportunity to
learn about A-Z of Labeling to Global labeling
process and practical challenges faced in
day-to-day operations from our duo experts
Gerrit-Jan Nijveldt, Senior Director, Regulatory
Labeling, Sanofi and Carlos Langezaal, PhD,
Director, Global Regulatory Affairs, Eisai, Inc.
Some of the points being covered are listed
below. Gerrit's Topic  "End-to-End Labeling
From Core Labeling Creation to Implementation 
  What is Core Labeling (short version)    How
to update a CCDS    Implementation of core
labeling    Tracking of implementation why how
and what    Agency inspection of labeling
implementation Carlos's Topic  Eisai's Global
Labeling Practices    Who is Eisai Global
Labeling and who are the stakeholders    Eisai
Global Labeling Function    Overview of Global
Labeling process    Practical challenges
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Speakers
Gerrit Jan NijveldtGerrit-Jan Nijveldt is
currently senior Director, Global Regulatory
Affairs Labeling for Sanofi in Bridgewater, NJ.
Gerrit and his team are responsible for
developing and maintaining Company Core Data
Sheets, US Prescribing Information and EU Summary
of Product Characterisation for the therapeutic
area Diabetes and Devices. Gerrit has an MSc in
Medical Biology from University of Utrecht in the
Netherlands and started working in pharmaceutical
industry in 1991 in the Netherlands and has
worked since 1997 in the Global Regulatory
Labeling department. Gerrit is also an associate
adjunct professor for Temple University School of
Pharmacy teaching Labeling where he teaches in
the Quality Assurance and Regulatory Affairs
Masters Program. Carlos Langezaal, PhDCarlos
R. Langezaal, Ph.D., Director, Global Regulatory
Affairs, is currently head of the Global Labeling
group which is a function in the Global
Regulatory Affairs Core Functional Unit at Eisai.
The Global Labeling group within Eisai is
responsible for a number of tasks including the
development, revision, review, and approval of
the Company Core Data Sheet and the Country
Product Information for all products globally.
Previously, he worked at Eisai, Sanofi-Aventis,
JJ PRD, Schering-Plough, Core Technologies, Eli
Lilly, and Baxter in various therapeutic areas,
including oncology, allergy, respiratory and
internal medicine. He has more than 20 years of
experience in regulatory affairs, having worked
in the device, device/drug combination products,
CMC and clinical/non-clinical development areas
primarily with a global focus.
Gerrit Jan NijveldtSenior Director,Regulatory Labeling,Sanofi Carlos LangezaalDirector, Global Regulatory Affairs,Eisai, Inc.