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Monday, June 19 • 11:00am - 12:15pm
#127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India

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

This panel will use a case study format and present the risk-based approach used to select sites for inspection and discuss the role of FDA’s international offices in facilitating inspections and engaging with regulatory counterparts in country. The forum will review violations that called into question the accuracy of data, and discuss the impact to drug applications.

Learning Objectives

Identify the risk-based approach for selecting firms for inspection and define the role of FDA’s international offices in inspections; Describe inspectional findings of a bioequivalence/bioanalytical firm in India that demonstrated significant violations impacting data quality; Discuss the process for considering regulatory impact of inspectional findings and implementing follow up actions.

Chair

Leslie Ball, MD

Speaker

Panelist
Sean Y. Kassim, PhD

Panelist
Mathew T. Thomas, MD

Panelist
Arindam Dasgupta, PhD


Speakers
avatar for Leslie Ball

Leslie Ball

Assistant Commissioner and Deputy Director, OIP, OC, FDA
Since September 2012, she has served as Assistant Commissioner and Deputy Director of the FDA’s Office of International Programs (OIP). OIP leads FDA’s international activities and oversees the operation of FDA’s eleven regional and country offices. Prior to this position, she... Read More →
avatar for Arindam Dasgupta

Arindam Dasgupta

Deputy Director, Division of New Drug Bioequivalence, OSIS, OTS, CDER, FDA
Arindam received his M.S. in Biophysics and Molecular Biology from the University of Calcutta (1994) and Ph.D in Molecular Biology from Jadavpur University, Kolkata. After finishing his Ph.D., he was a postdoctoral researcher at UVA and NIH (1999-2008). He joined CDER as a Pharmacologist... Read More →
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
avatar for Mathew Thomas

Mathew Thomas

Country Director, India Office, Office of International Programs, OC, FDA
Dr. Mathew T. Thomas serves as the Acting Director for the FDA India Office from February 23, 2015. Prior to this posting Mathew was the Director of the Division of Enforcement and Postmarket Safety (DEPS), in CDER’s Office of Scientific Investigations (OSI) within the Office of... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Forum