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3rd Safety Labeling and Packaging Summit -

3rd Safety Labeling and Packaging Summit
September 24 - 25, 2019
Morristown, NJ

Address regulation requirements to increase patient safety and compliance while maximizing efficiency at minimal cost

Agenda – 3rd Safety Labeling and Packaging Summit

Conference Day One

 Tuesday, September 24, 2019

9:00AM – 10:00AM

Best Practices for Meeting Labeling and Packaging Timelines

Kathleen Crowder, Sr. Manager, Global Regulatory Affairs, Labeling, BAXTER INTERNATIONAL

10:00AM – 10:45AM

Achieve Supply Chain Efficiency During Packaging and Labeling

Kathleen Salazar, Director, Global Labeling Operations, JANSSEN

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Align Quality Measures Across Various Stages of the Product Life Cycle to Reduce Waste and Labeling Defects

Georgina Lee, Associate Director, Regulatory Affairs, AGIOS PHARMACEUTICALS

12:00PM – 12:45PM

Carousel Discussion Exercise

12:45PM – 1:45PM


1:45PM – 2:30PM

Manage Packaging and Labeling at Contract Manufacturing Organizations

Hernan Gonzalez, Manager — External Supply, PFIZER

2:30PM – 3:15PM

Prepare for an Evolving and Changing Labeling Regulatory Landscape

Jaylaxmi Nalawade, Associate Director, Pharmacovigilance and REMS, LUPIN PHARMACEUTICALS

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Presentation by Indegene

Anand Kiran, Executive Vice PResident, INDEGENE

4:30PM – 4:30PM

Day One Concludes

Conference Day Two

 Wednesday, September 25, 2019

8:00AM – 8:45AM

Continental Breakfast

9:00AM – 9:45AM

Manage the Complexities of Global Labeling Requirements

Stephanie Huguette Bodo Kamga, Senior Director Global Regulatory Affairs, IPSEN

9:45AM – 10:30AM

Continuous Improvement and Change to Global UDI

Roger Peterson, Manager, Global Labeling Systems, ARTHREX

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Regulatory Grey Areas in Labeling and Packaging

Mark Collins, Global Labeling Lead, CSL BEHRING

11:45AM – 12:30PM

EU MDR/IVDR Labeling Consideration and Implications

Zak Macht, Senior Manager, Labeling Global Regulatory Operations, BECTON DICKINSON COMPANY

12:30PM – 1:30PM


1:30PM – 2:15PM

Progress Your Journey and Innovate Through a Fully Digitalized Labeling Strategy

Remon Zakhary, Packaging Design and Development, Senior Group Lead, BAYER HEALTHCARE

2:15PM – 3:00PM

Package for the Future and Advancements in Safety Labeling

Gerrit-Jan Nijveldt, Senior Director, Global Regulatory Labeling, SANOFI

3:00PM – 3:00PM

Conference Concludes

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