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Thursday, July 1 • 2:00pm - 3:00pm
#440 SL: Predictive Compliance, Risk, and Quality Management Transformation: Will your Data Hold up to a Data Integrity Inspection?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-662-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide information to discuss regulatory and sponsor oversight and the need to increase the communication risks to stakeholders in real-time for critical study-related activities, and how sponsors need a system that will predict and manage risk using modern digital technology platforms.

Learning Objectives

Describe compliance risk prediction possibilities and how a digital technology platform, risk predictor, helps to capture, identify, mitigate, trend risk, and prioritize actions that are important to the pharma and medical device industry; Discuss how to integrate data from different data sources/platforms and shown tools.

Chair

Kamal Biswas

Speaker

Panelist
Sherri Ann Hubby

Panelist
Andrew Fisher, MS

FDA Update
Cheryl Grandinetti, PharmD

Panelist
Jane von Kirchbach, MBA


Speakers
avatar for Sherri Hubby

Sherri Hubby

Senior Director, GCP Quality Assurance, Myovant Sciences , United States
Sherri Hubby has over 20 years of Global Quality Assurance management, auditing and training experience with emphasis in the GCP and GMP area for vendors, and sites including inspection hosting experience for the (CRO)/Pharmaceutical/Biotech/Medical Device and IRB industry. Most recently... Read More →
avatar for Kamal Biswas

Kamal Biswas

President, Xybion Corporation, United States
Kamal is the President and Chief Operating Officer at Xybion. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. He spent several years working with pharma companies including Novartis... Read More →
avatar for Andrew Fisher

Andrew Fisher

Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Andy has been with the MHRA GCP Inspectorate since August 2005 and has inspected numerous commercial and non-commercial organisations, contract research organisations, eSystems vendors, phase 1 clinical units and investigator sites as part of the MHRA and EMA inspections. Andy also... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
avatar for Jane von Kirchbach

Jane von Kirchbach

Vice President, Pfizer Digital, Pfizer Inc, United States
Jane von Kirchbach is Vice President at Pfizer, a research-based global biopharmaceutical company. She is passionate about driving digital transformation and delivering breakthroughs that change patients’ lives and improve healthcare around the world. Jane is responsible for digital... Read More →

Thursday July 1, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Forum |   03: Data-Data Standards, Forum