Gerrit Jan Nijveldt Carlos Langezaal
Senior Director, Director,
Regulatory Labeling, Global Regulatory Affairs,
Sanofi Eisai, Inc.
This is a significant year as far as rule making for labeling is concerned. Several labeling regulations are anticipated this year. Designing a Product label that is compliant with the current FDA regulations is complex and time taking. Pharmaceutical companies are constantly managing product-labeling documents such as Package Inserts (PIs), Summaries of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). The same information is often duplicated for various product strengths, dosage forms and presentations, resulting in an overwhelming set of labeling records that are difficult to manage and keep synchronized.
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
Date/ Time: Thursday,May 19th @ 11am EST
Gerrit Jan Nijveldt
Gerrit-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, PhD
Carlos 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, J&J 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.
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