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Monday, June 20 • 4:00pm - 5:00pm
#138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-531-L04-P ; CME 1.00; RN 1.00

Global regulators will discuss their perspectives on ICH E8(R1) and the importance of implementing quality-by-design principles and practices in the planning, conduct, and reporting of clinical trials.

Learning Objectives

Discuss quality-by-design principles;Describe how effective proactive implementation of quality-by-design principles impacts clinical development; Discuss regulator’s perspectives on the role of quality-by-design to ensure a clinical study results in data that is fit for purpose.

Chair

Jean M. Mulinde, MD

Speaker

FDA Update
Ann Meeker-o`Connell, MS

MHRA Update
Mandy Budwal-Jagait, MSc


Speakers
avatar for Ann Meeker-o`Connell

Ann Meeker-o`Connell

Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC, FDA, United States
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that coordinates the development of human subject protection and good clinical practice policy across the agency. Ms. Meeker-O’Connell... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  08: RD Quality-Compliance, Forum