Patient-Centric Specifications from an Industry and Regulator Perspective

Extended Learning
Learning Level: Intermediate
Time: 1100 - 0130 ET
Session Length: 2.5 hours

The objective for this webinar is to bring regulatory and industry representatives together to discuss their perspectives on implementation of patient-centric specifications.

The rationale for patient-centric or clinically relevant specifications are articulated in two quotes from “FDA Pharmaceutical Quality Oversight: One Quality Voice ”

“Clinically relevant specifications can be defined as a set of criteria and acceptance ranges to which drug products should conform in order to deliver the therapeutic benefit indicated in the label.”

“Clinically relevant specifications increase flexibility within the pharmaceutical manufacturing sector while maintaining quality by establishing acceptance criteria based on clinical relevance, instead of process capability or manufacturing process control.”

Several recent publications from Industry have focused on the establishment of patient-centric specifications.

This webinar will focus on the regulatory expectations for a company to establish clinically relevant specifications. The session will include brief presentations from industry and regulators and will be followed by an extended panel discussion.

Learning Objectives

  1. Hear from industry representatives about their perspectives on implementation of patient-centric specifications
  2. Hear from regulatory representatives about their perspectives on implementation of patient-centric specifications
  3. Have a panel discussion with industry and agency representatives to clarify points of agreement and areas where further discussion is required.

Speakers

Placeholder Person Graphic
Fiona Cornel
Acting Manager Monoclonal Antibodies Division-Oncology, CERB
Health Canada
Taro Fujimori
Director
AbbVie Bioresearch Center, Inc.
Julia O'Neill
Principal
Direxa Consulting LLC
Mats Welin
Senior Expert
Lakemedelsverket
Lawrence X. Yu, PhD
Director, Office of New Drug Products
OPQ/CDER/FDA

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Member $49
Nonmember   $75 
Student* $25

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