Global Clinical Quality Conference 2021: Full Schedule

10:15am EDT

SENIOR LEADERS PANEL: Culture of Quality

Driven by the Modernized ICH E8(R1), Organizations Must Be Able to Detect and Monitor Quality Culture: Are You Ready?

Discuss the definition of a culture of quality and the drivers
Understand strategies for assessing the health of your quality culture and identify/remediate gaps
How do you document an effective culture of quality?
Review lessons learned on how quality cultures were tested during the pandemic

Speakers

Nabil Girgis, MD, CQA

Senior Director, R&D Quality Assurance, NEKTAR

Clinical quality executive with 28 years of diverse, comprehensive medical and scientific experience across GXP in clinical drug development. Proven record of accomplishments in implementing successful Inspection Readiness (IR) programs and effective management of regulatory inspections... Read More →

Dr. Hanna Preus

Senior Quality Director, OPIANT PHARMACEUTICALS

Global Quality & Compliance Expert, Auditor and Business Strategist with nearly 20 years of versatile operational excellence experience in clinical trial industry across global processes and functions working within Pharmaceutical Companies and Contract Research Organisations across... Read More →

Sheila Gwizdak, M.S.

Vice President, Quality, HALLORAN CONSULTING GROUP

Sheila Gwizdak has over 18 years of experience in the biotechnology and pharmaceutical industry. Her career has focused on quality, process improvement, and training including the execution of corporate and department-level quality assurance initiatives such as SOP development, compliance... Read More →

David Fryrear

Executive Vice President, Head of Quality Assurance, ASTELLAS

David Fryrear, M.S., is Executive Vice President and Head of the Quality Assurance for Astellas and has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development, and... Read More →

Wednesday April 7, 2021 10:15am - 11:15am EDT

Panel Discussion

1:30pm EDT

CRO PANEL: Optimize Clinical Quality at the CRO-Level

Understand How Trial Sponsors Can Best Leverage the Expertise of Their CRO Partner to Optimize Clinical Quality

Discuss the value and expertise your CRO brings to the table
Evaluate how trial sponsors can help CROs reach their full potential
Identify barriers and obstacles that impede quality in the clinical space and how to overcome them

Speakers

Sharon Reinhard

Vice President, R&D QA, CSL BEHRING

Experienced pharmaceutical executive with 23 years of industry experience, most recently as Vice President of R&D Quality with CSL Behring where I have responsibility for GCP, GLP, GVP, early GMP, and combination product quality as well as the QMS. Prior to that I spent 3.5 years... Read More →

Bhausaheb Patil

Senior Director, Quality Management, IQVIA

As a 25 year veteran of IQVIA, Bhau currently serves as senior director within IQVIA’s Quality Management and Operational Transformation and Performance group. Starting as a clinical trial assistant, Bhau has served in a variety of functions including clinical monitoring, project... Read More →

Dawn Niccum

Senior Director, QA and Compliance, INSEPTION GROUP

Dawn Niccum is Senior Director, Quality Assurance and Compliance for the inSeption Group and responsible for all areas of QA including compliance, Policies and SOPs, and training. She was formerly with Endocyte, Inc. as Associate Director, QA. With over 20 years of pharmaceutical... Read More →

Kristin Stallcup

Senior Director, Customer Success, COVANCE

Kristin Stallcup brings 15 years of industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of the Xcellerate Informatics suite into business process. Previously she served in central monitoring... Read More →

Kimberly Washburn

Vice President, Quality, CATO SMS

Kimberly Washburn as VP Quality for CATO SMS has more than 25 years’ experience in quality/compliance leadership (e.g., design and implementation of Quality Assurance and Compliance programs at a global level) and auditing within a regulated clinical research and quality assurance/management... Read More →

Wednesday April 7, 2021 1:30pm - 2:30pm EDT

Panel Discussion

8:45am EDT

PANEL DISCUSSION: Global Inspection Gossip

Share Recent Experiences with Inspections and Other Engagement with Various Regulatory Authorities

Discuss recent inspection experiences during the pandemic
- Share communication with regulatory agencies during the pandemic
- Were you part of a hybrid or remote inspection? What did that look like?
Understand experiences with direct access to systems and the associated challenges
Receive an update on China GCP and the associated challenges

Speakers

Mike Sobczyk

Executive Director, R&D Quality and Compliance, Gilead Sciences

Mike Sobczyk has a Bachelor of Science degree in biology from the University of Nebraska at Omaha and a Master of Health Sciences from George Washington University. Mike is currently working at Gilead Sciences Inc. as the Executive Director of R&D Quality and Compliance. Over the... Read More →

David M. Potter

Clinical Inspection Readiness & Risk Management Lead, KYOWA KIRIN

David Potter has been in the Pharma Industry for the past 28 years. He is currently and has been at Kyowa Kirin USA Holdings, Inc. and has for the past 13 years. He served in the Biometrics Group as the head of Data Management and Programming while supporting the growth and development... Read More →

David Fryrear

Executive Vice President, Head of Quality Assurance, ASTELLAS

Michele Weitz

Senior Director, Clinical Operations Standards and Innovation, CLOVIS ONCOLOGY

A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around... Read More →

Thursday April 8, 2021 8:45am - 9:45am EDT

Panel Discussion