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Omni Shoreham Hotel

2016 年 09 月 12 日 7:00 上午 - 2016 年 09 月 13 日 5:00 下午

2500 Calvert Street NW, , Washington, DC 20008 , USA

Global Labeling 2016

Essential Updates on Worldwide Regulations and Guidelines

返回 Agenda

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 Regulatory perspectives include insights from an FDA Safety Reviewer, and a discussion on Canada’s draft guidance, “Good Label and Packaging Practices Guide (2015)”.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)

Considerations to be Taken When Developing the Packaging Materials

Anthony Bantug, MS

Amgen, United States

Principal Engineer, Packaging Engineering and Labeling

Jibril Abdus-Samad, PharmD

Common Deficiencies in Container Labels and Carton Labeling for Biological Products

Jibril Abdus-Samad, PharmD

FDA, United States

LCDR, Labeling Reviewer, Office of Biotechnology Products, OPQ, CDER

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

Veronica Yip

Health Canada (TPD), Canada

Acting Manager, Labelling Division