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#109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Monday June 16, 2025 11:00am - 12:00pm EDT
152AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-515-L04-P; CME 1.00; RN 1.00

This forum will discuss Good Clinical Practice (GCP) inspection methods, collaboration and training among regulators and their inspectors as they respond to the evolving clinical trial regulatory landscape such as the implementation of ICH E6 R3 and novel trial methodologies

Learning Objectives

Describe the reasons why regulators may inspect clinical trials in different ways; Compare the various inspection approaches used by different regulators; Explain how regulators are harmonizing inspection approaches and collaborating to share information, resources, and training; Analyze how regulators are preparing to implement ICH E6 R3 and its implications for inspections and inspector training.

Chair

Mandy Kaur Budwal-Jagait, MSc

Speaker

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Kavita C. Dada, PharmD, RAC

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Adil Nashed

Panelist
Peter Twomey, MA, MPharm

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Reina Hayashi


Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, 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 →
avatar for Kavita Dada

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
Captain Kavita Dada, Pharm.D., RAC, is the Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at FDA's Center for Drug Evaluation and Research. With over 20 years of regulatory experience, she leads initiatives to modernize... Read More →
RH

Reina Hayashi

Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reina Hayashi currently serves as an inspector of the Office of Non-clinical and Clinical Compliance in the Pharmaceuticals and Medical Devices Agency (PMDA).
avatar for Adil Nashed

Adil Nashed

Drug Specialist, Health Canada, Canada
Adil Nashed graduated as a Veterinarian from University of Khartoum, Sudan.He successfully completed his Veterinary Internship in Vienna, Austria under the supervision of the University of Vienna. Adil also holds a post graduate diploma in Homeopathic Medicine and Science from the... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum |   02: ClinTrials-Ops, Forum

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