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Monday, June 16
 

11:00am EDT

#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
Adil Nashed

Panelist
Peter Twomey, MA, MPharm

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
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

2:15pm EDT

#130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-527-L04-P; CME 1.00; RN 1.00

This forum will present: Health Authority (HA) expectations related to QbD, RBQM, and issue management. Specific examples of how study teams use technology to overcome challenges in achieving QbD and effective RBQM and issue management practices.

Learning Objectives

Discuss Health Authority (HA) expectations when designing and executing clinical studies, specifically for using risk proportionate approaches in Quality by Design (QbD), Risk Based Quality Management (RBQM) and issue management practices; Describe real life examples of technologies that facilitate the achievement of HA expectations for QbD, RBQM, and issue management.

Chair

Michael Torok, PhD

Speaker

Industry Perspective
Michael Torok, PhD

FDA Perspective
Emily Gebbia, JD

Industry Perspective
Kevin Richards, MSc


Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
avatar for Kevin Richards

Kevin Richards

Senior Director, Clinical Quality, AstraZeneca, Canada
Lead the Global Clinical Quality organization at AstraZeneca leading quality compliance and GCP processes and teams. He established and also leads Study Quality Oversight, automated reporting, solutions and tools to help uplift study and organizational inspection readiness and compliance... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   03: Data-Tech, Session |   02: ClinTrials-Ops, Session

3:45pm EDT

#145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-543-L04-P; CME 1.00; RN 1.00

This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.

Learning Objectives

Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.

Chair

Emily Gebbia, JD

Speaker

Industry Perspective
Robert DiCicco, PharmD

MHRA Perspective
Jason Wakelin-Smith


Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session
 
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143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
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Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking-Opportunities
  • 20: Short-Courses
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  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming