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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.

Chair

Sandra L. Kweder

Speaker

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



Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER, FDA
Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a pediatric Infectious Disease spe... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Dr. Kweder has been in her position in 2016, and previously held a number of leadership positions in CDER. Her work there focused on improving review processes to build a high performing organization that values scientific rigor, open discourse and high quality decision making. T... Read More →
avatar for Anabela Marcal

Anabela Marcal

Head of Compliance and Inspections Department, European Medicines Agency, European Union
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 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 the Johnson & Johnson Consumer Sector. In this role, Ann oversees a global program for GCP, GLP, and Safety Vigilance oversight. Prior to J&J, Ann served as Director of the Division of Good Clinical Practice Comp... 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 at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She... Read More →


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