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Tuesday, June 20 • 4:00pm - 5:00pm
#291: Combination Products

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Component Type: Session
Level: Intermediate

A workshop to explore the world of combination product safety. Discuss the real-world, least burdensome approach to Postmarket Safety Reporting (PMSR) for US Combination Products, in light of the final rule. Help the audience appreciate the complexity of implementing PMSR in a global organization. Participants will work in teams to work through mock case(s) of combination products approved as drug application type with a device constituent part. We will have interactive discussion about key challenges including global impact and highlight industry best practices.

Learning Objectives

Describe the basic requirements as highlighted in the final rule; Identify simple solutions to comply with the regulation.

Chair

Khaudeja Bano, MD, MS

Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Senior Medical Director, Medical Affairs, Diagnostics, Abbott Laboratories
Khaudeja is a Physician with Masters in Clinical Research, Pharmaceutical Engineering Certification, a DBA, and a certified Project Management Professional. She is an avid Toastmaster and a certified coach. Khaudeja has 25 years of professional experience, including clinical practice... Read More →

Tuesday June 20, 2017 4:00pm - 5:00pm CDT
Exhibit Hall McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  15:Engage-Exchange, Session |   05: Regulatory, Session
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  • Featured Topics Devices-Combination Products
  • Tags Session