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08: R-D Quality-Compliance [clear filter]
Monday, June 24
 

5:15pm

#175 EE: Data Analytics Use in Quality Processes
Component Type: Workshop
Level: Advanced

Roche is using data analytics as a key component for planning and conducting audits and providing ongoing support to our study teams. A brief overview will be given, and participants will be invited to share their experiences.

Learning Objectives

Discuss how Roche is integrating data analytics into issue/audit management; Describe how other companies are/will be using data analytics in support of their quality processes.

Chair

Eileen Magruder, DrMed, MD

Speaker

Facilitator
Alaina Barros



Speakers
avatar for Alaina Barros

Alaina Barros

Principal Auditor/Quality Program Lead, Genentech, A Member of the Roche Group
Alaina Barros has worked within the pharmaceutical industry for 17+ years in the areas of manufacturing, clinical operations and quality. She is currently employed with Genentech, a member of the Roche Group, as a Quality Program Lead/Principal Auditor.
avatar for Eileen Magruder

Eileen Magruder

Senior Auditor, Product Development Quality- PDQ-AFM, Genentech, A Member of the Roche Group
Eileen E. Magruder, MD has over 20 years of experience as a GCP and PV auditor. She is currently a senior auditor for the Product Development Quality - Audit and Finding Management team at Genentech, Inc., a member of the Roche Group.


Monday June 24, 2019 5:15pm - 6:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#409: Case Studies From FDA and MHRA: Good Clinical Practices
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-723-L04-P; CME 1.25; IACET 1.25; RN 1.25

If you were not able to join in person on day two of the FDA-MHRA Good Clinical Practice Workshop, Data Integrity in Global Clinical Trials – Are We There Yet? last October, and missed the case study sessions, you will have a second chance in this Workshop. Attendees will work with regulators on two of the previously presented case studies to investigate data integrity and discuss the impact of their findings on overall study reliability.

Learning Objectives

Evaluate how data management practices may impact data integrity and reliability; Discuss how data integrity is key to vendor selection; Describe and evaluate the impact of data blinding on data reliability; Evaluate how audit trails may be used to assess data integrity.

Chair

Gail Francis

Speaker

MHRA Perspective
Stephen Vinter

FDA Perspective
Jean M. Mulinde, MD



Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... 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 Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA