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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 4: Innovative Package Design and Labeling

Session Chair(s)

Mark Collins, PhD, MBA

Mark Collins, PhD, MBA

Principal Consultant, Opus Regulatory, United States

This session includes invited speakers from industry, FDA, and Health Canada to provide a balanced view of packaging issues. The industry portion will discuss considerations and challenges when developing the packaging materials, including timing (when to start), branding, and regional differences. Regulatory perspectives include insights from an FDA Safety Reviewer, and a discussion on Canada’s draft guidance, “Good Label and Packaging Practices Guide (2015)”.

Speaker(s)

Anthony Bantug, MS

Principal Engineer, Packaging Engineering and Labeling, Amgen, United States

Considerations to be Taken When Developing the Packaging Materials

Jibril Abdus-Samad, PharmD

Jibril Abdus-Samad, PharmD

LCDR, Labeling Reviewer, Office of Biotechnology Products, OPQ, CDER, FDA, United States

Common Deficiencies in Container Labels and Carton Labeling for Biological Products

Veronica Yip

Manager, Labelling Division, Health Canada (PDD), Canada

Application of the Good Label and Packages Practices Guide For Prescription Drugs in the Therapeutic Products Directorate's Review of Mock-Up Labels

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