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Wednesday, June 27 • 4:00pm - 5:15pm
#393: Think Like a Regulator: Evaluating Trial Integrity

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-683-L04-P; CME 1.25; IACET 1.25; RN 1.25

Are you involved in auditing clinical trials, and working through applying the risk-based approach advocated by ICH E6 R2 to your audit program? This workshop will help you understand how review staff from international regulatory authorities evaluate non-compliance and its impact on trial and marketing application integrity. As one of eighty participants, you will learn how regulators determine what clinical trial data and processes are critical to the credibility of conclusions made based on clinical trial data and how this translates to their review of inspection findings . You’ll get hands-on practice discussing real-life inspectional finding, and you’ll have the opportunity to share how you would advise the regulatory review team on the impact to quality. You leave with tangible approaches you can take home to your company.

Learning Objectives

Describe how regulators determine what is critical to quality for a clinical trial and where risks may materialize; Apply this approach through reviewing inspection observations and evaluating their relevance to the credibility of clinical trials

Chair

Ann Meeker-O'Connell, MS

Speaker

Facilitator
Hitoshi Ozawa, MPharm

Facilitator
Jean M. Mulinde, MD

Facilitator
Anabela Marcal, PharmD



Speakers
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 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 Ann Meeker-O'Connell

Ann Meeker-O'Connell

Vice President, Global Head, Quality Assurance, IQVIA
Ann Meeker-O’Connell, MS, serves as Vice President and Global Quality Head at IQVIA. She previously served as Head/Senior Director, BioResearch Quality & Compliance, and as Head of Risk Management & External Engagement, for J&J Consumer. Ann has more than twenty years of experience... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, 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 Hitoshi Ozawa

Hitoshi Ozawa

GCP Inspector, Office of Non-Clininical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA)
I am GCP Inspector, Office of Non-Clininical and Clinical Compliance, PMDA. I was in charge of inspection of post-marketing surveillance. And I am also member of program committee of 21st DIA Annual Workshop in Japan for Clinical Data Management.


Wednesday June 27, 2018 4:00pm - 5:15pm
Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA