U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. CDER Small Business & Industry Assistance (SBIA)
  5. Regulatory Education for Industry (REdI): FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet? October 23-24, 2018 - 10/22/2018
  1. CDER Small Business & Industry Assistance (SBIA)

Public | In Person

Event Title
Regulatory Education for Industry (REdI): FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet? October 23-24, 2018
October 22 - 23, 2018


Date:
October 22 - 23, 2018
Time:
8:00 PM - 8:00 PM ET

 

 Agenda

 

Why Attend?

Regulatory agencies conduct Good Clinical Practice (GCP) inspections to verify the reliability of data generated in clinical trials and adequacy of human subject protection, in addition to ensuring that clinical trials are conducted according to the applicable regulations. In this era of globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct to optimize regulatory resources and oversight.

This workshop will provide US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Medicines and Healthcare products Regulatory Agency UK (MHRA) perspectives on the importance of quality management practices on data reliability. It will provide regulatory perspectives on data management, data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials. The workshop participants will have opportunities to work on relevant case studies on these topics.

Workshop Objectives:

At this event, participants will learn:

  • Regulatory perspectives on importance of quality management systems on data reliability
  • How data management practices may impact data reliability
  • Impact of data blinding on data reliability
  • How audit trails may be used to assess data integrity
  • How to evaluate data integrity/reliability using case examples

Who Should Attend?

  • Clinical Quality Assurance Professionals
  • Clinical Operations Professionals
  • Data Management Professionals
  • Clinical Trial Electronic Systems Developers
  • Clinical Trial Statisticians and Statistical Programmers
  • Clinical Investigators and Clinical Investigator Site Staff
  • Regulators- GCP inspectors
  • Regulators- Reviewers/Assessors of Clinical Trial Data 

Presentation 

Speaker 

Welcome  and  Data Quality: Why Do We Care?  

David Burrow, PharmD, JD  

Director 

Office of Scientific Integrity, Office of Compliance, CDER 

Robert J. Temple, MD 

Deputy Center Director for Clinical Science, CDER

Data Integrity from International Perspectives 

Ni Khin, MD Director 

Division of Clinical Compliance Evaluation (DCCE), Office of Scientific Investigations (OSI), CDER, FDA 

Gail Francis 

Expert GCP Inspector MHRA 

Quality Management Systems and Quality by Design 

Jean Mulinde, MD 

Senior Advisor 

DCCE/OSI, CDER, FDA 

 

Overview of Data Integrity

Gail Francis 

Expert GCP Inspector 

MHRA 

Good Clinical Practice Assessment of Data Reliability in Registration Trials

Kassa Ayalew, MD, MPH 

Branch Chief 

DCCE/OSI,CDER/FDA

Quality and Control of Clinical Trial Data  

Andy Fisher 

Lead Senior GCP Inspector 

MHRA

The Data Management Plan – Pulling It All Together  

Cynthia Kleppinger, M.D 

Senior Medical Officer 

DCCE/OSI, CDER/FDA

Unblinding – Let Me Count the Ways…

Gail Francis 

Expert GCP Inspector 

MHRA 

Jean Mulinde, MD 

Senior Advisor 

DCCE/OSI, CDER, FDA

Blinding of Bioequivalence Trials  

Seongeun (Julia) Cho, Ph.D., Director 

Division of Generic Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance (OSIS), CDER/FDA

Effective Use of Audit Trails  

Stephen Vinter,  

Operations Manager  

GLPMA & Laboratories Group, MHRA 

A Case Example of the Review of Audit Trails in GCP Inspections  

Phillip Kronstein, MD 

Team Lead 

DCCE/OSI, CDER/FDA

FDA & MHRA Resources


Event Materials

Title File Type/Size
09-28-21-16-74-29-GCP2018-Agenda pdf (1.47 MB)
 
Back to Top