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Wednesday, June 27 • 10:30am - 11:45am
#339: Determining Data Integrity: Decoding the Impact of Inspectional Observations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-648-L04-P; CME 1.25; IACET 1.25; RN 1.25

Regulatory authorities rely on inspections of the entities conducting clinical trials to ensure the validity of data and that this data is of sufficient quality to serve as the basis for regulatory decisions. An update on the comparison of EMA and FDA GCP findings of entities that have been inspected by both agencies, will set the stage for this session that will help you understand the impact of inspectional observations on regulators determinations on the adequacy of your data. The session will include discussion of analytic, sponsor, contract research organization, and clinical investigator inspectional findings and why these findings may raise concerns about the validity of data in marketing applications.

Learning Objectives

Identify similarities and differences in how the EMA and FDA report on and classify inspectional findings; Describe how inspectional observations impact regulators’ thinking on the validity and integrity of clinical trial data submitted in marketing applications.

Chair

Jean M. Mulinde, MD

Speaker

Panelist
Anabela Marcal, PharmD

Panelist
David C. Burrow

Panelist
Sally Choe, PhD

Panelist
Jenn W. Sellers, MD


Speakers
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA
David Burrow currently serves as the Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, he is responsible for the strategic administration... Read More →
SC

Sally Choe

Director, Office of Generic Drugs, CDER, FDA
Dr. Choe is the deputy director of the Office of Study Integrity and Surveillance (OSIS) in the Office of Translational Sciences (OTS) in FDA’s Center for Drugs (CDER). OSIS oversees bioequivalence and bioavailability studies and non-clinical laboratories in support of pharmaceutical... Read More →
avatar for Anabela Marcal

Anabela Marcal

Head of Committees and Inspections Department, European Medicines Agency (EMA),
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.
avatar for Jean Mulinde

Jean Mulinde

Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
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 Jenn Sellers

Jenn Sellers

Medical Officer, OSI, OC, CDER, FDA
Dr. Sellers is a board certified pediatrician working as a senior medical officer for Good Clinical Practice Assessment Branch in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She has clinical experience for over 20 years. She also... Read More →

Wednesday June 27, 2018 10:30am - 11:45am EDT
Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Session