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Tuesday, June 20 • 2:00pm - 3:15pm
#261: Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

EMA and FDA collaborative inspections of clinical investigators, sponsors and CROs of clinical trials submitted in support of marketing applications of new drug products have the same objectives of data verification and human subject protection. The goals of the EMA-FDA collaborative initiative are to conduct periodic information exchanges on GCP-related information streamline sharing of GCP inspection planning information, communicate on inspection outcomes effectively and in a timely manner, conduct collaborative GCP inspections by sharing information, experience and inspection procedures, co-operating in the conduct of inspections and sharing knowledge of best practice; share information on the interpretation of GCP, by keeping each other informed of GCP-related legislation, regulatory guidance and related documents and to identify and act together to benefit the clinical research process. Since the EMA-FDA collaborative initiative began in 2009, approximately 48 entities have been inspected by both EMA and FDA for shared applications. This session will characterize and compare the EMA and FDA GCP findings from the 48 entities inspected by both agencies; and provide insight about the extent of the similarities and differences of these common inspections.

Learning Objectives

Identify the shared pre-market applications with common inspections by both EMA and FDA; Compare the inspectional findings of the common inspections; Summarize the similarities and differences of the common inspections by EMA and FDA.


Sandra L. Kweder


An Overview of EMA-FDA Good Clinical Practice (GCP) Collaboration: Focus on Comparison of Inspection Findings Project
Kassa Ayalew, MD, MPH

EMA Perspectives
Anabela Marcal, PharmD

Preliminary GCP Inspection Findings from Common Marketing Applications: Differences and Similarities
Jenn W. Sellers, MD

Comments from Industry Perspectives
Ann Meeker-O'Connell, MS

avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with over several years of clinical... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
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, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Senior Director/ Head, BioResearch Quality and Compliance, Consumer Products, Johnson & Johnson
Ann Meeker-O’Connell heads BioResearch Quality and Compliance for Johnson & Johnson’s Consumer sector, with global responsibility for GCP, GLP, and PV oversight. Prior to J&J, Ann led the Division of GCP Compliance at FDA’s Center for Drug Evaluation and Research. Ann has more... Read More →
avatar for Jenn Sellers

Jenn Sellers

Senior Medical Officer, FDA, United States
Dr. Sellers is a board certified pediatrician working as a senior medical officer at 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 →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
N229 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Session
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  • Credit Type CME, IACET, RN
  • Tags Session