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 p.m. - 8:00 p.m. ET

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)