Global Clinical Quality Conference 2021: Full Schedule

8:45am EDT

CRITICAL THINKING IN CLINICAL RESEARCH

Create an Environment That Fosters Critical Thinking to Optimize Global Clinical Quality

Understand how the pandemic has forced us to think critically about how we adapt clinical research and quality oversight approaches in the most pragmatic, timely, and compliant way putting our patients, consumers, and customers first.
Create the burning platform for critical thinking through evolution and greater availability of data, documentation, and adoption of new technology in clinical research
Recognize the importance of fostering a culture that values critical thinking, creates the opportunity for Quality to transform itself and its capabilities, and enables Quality to differentiate itself as a valuable partner

Speakers

Paul Houri

Vice President, Head of BioResearch Quality Assurance, JOHNSON & JOHNSON

Paul Houri is currently the Vice President, Head of BioResearch Quality Assurance at Johnson & Johnson. Paul is responsible for setting the vision and strategy for BioResearch Quality Assurance, a global team focused on execution of non-regulated, GLP, GCP and PV audits and quality... Read More →

Wednesday April 7, 2021 8:45am - 9:15am EDT

Presentation

9:15am EDT

OPTIMIZE SITE TRAINING

Teach Critical Thinking and Minimize Risk Through Simulation-Based Protocol Training with Proven Knowledge Retention

Define simulation-based training and what that means in the clinical research space
Monitor human performance at the protocol-level
Reduce risks through automated protocol amendment communication
Recognize the knowledge retention benefits of adaptive learning

Speakers

David Hadden

President and Co-Founder, PRO-FICIENCY

David is an entrepreneur and technology innovator known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS).Since selling TheraSim, the first successful online VPS system for physicians, to WebMD in 2014, he has... Read More →

Wednesday April 7, 2021 9:15am - 9:45am EDT

Presentation

11:15am EDT

KRI vs. QTL

Distinguish Key Risk Indicators (KRIs) from Quality Tolerance Limits (QTLs) and Why This is Important

Identify the critical differences between KRIs and QTLs
Examine examples of both KRIs and QTLs and discuss how they are different

Speakers

Brigid Flanagan

Senior Consultant, THE AVOCA GROUP

Brigid Flanagan BA, RN, CCRC, MSB, MRQA, a senior consultant for The Avoca Group, is a research professional with 20+ years’ experience in clinical operations.Brigid has been an active member of ACRP since 1998 and served on their Professional Ethics Committee for 5 years.She has... Read More →

Wednesday April 7, 2021 11:15am - 11:45am EDT

Presentation

1:00pm EDT

CASE STUDY: GOVERNANCE OF QUALITY

From Site to CEO; A Pathway for Prioritizing and Communicating Enterprise GCP Quality Risk

Transform information into a language that engages senior leadership about issues and risks
Synthesize millions of data points into a clear picture of where the risks lie across the processes, the portfolio, vendor partners, etc.
Walk through a case study demonstrating a data driven approach to renovating the GCP Quality Review meeting

Speakers

Jonathan Rowe

Head of R&D Quality Risk Management, ZS

Jonathan Rowe has 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of R&D Quality and Risk Management at ZS Associates. From 2014-2019... Read More →

Wednesday April 7, 2021 1:00pm - 1:30pm EDT

Presentation

9:45am EDT

NEXT GENERATION GCP AUDITING

Leverage Internal, Site and Vendor Audits to Proactively and Remotely Manage Risk

Uncover how GCP auditing has evolved and identify the drivers
Understand how risk-based auditing fits into your risk management plan
Evaluate how auditing data can assist in proactively identifying issues and mitigating risk
Develop and adjust your risk-based auditing approach to optimize effectiveness

Speakers

Carol Bognar

CEO and QA Consultant, CAROL BOGNAR CONSULTING, INC.

Carol Bognar is an Independent GCP Consultant and was formerly Vice President for GCP Services at The Weinberg Group. Carol is a recognized industry expert in Clinical Quality Assurance with a broad range of experience, having over 25 years of experience working as a QA auditor and... Read More →

Thursday April 8, 2021 9:45am - 10:15am EDT

Presentation

10:30am EDT

CASE STUDY: RISK-BASED CLINICAL CAPA MANAGEMENT

Learn a Step-by-Step Approach for Emerging Out of “Death by CAPA” through a Risk-Based Categorization and Prioritization Approach

Define specific criteria for what should and should not be a CAPA
Build an enterprise-wide system/plan for housing and tracking CAPA
Design a process flow for handling CAPA and those issues that do not qualify as a CAPA
Lessons learned from the experience and advice for those currently overwhelmed with too many CAPA

Speakers

Pearl Boayke

Head, Compliance Management, BAYER HEALTHCARE UK

Pearl joined Bayer UK in 1993 as a Clinical Research Scientist, and over the years has held positions within Monitoring, Study Management, Line Management, Outsourcing and Operational Support across a variety of therapeutic areas. She spent a year working in Bayer’s New Jersey office.In... Read More →

Thursday April 8, 2021 10:30am - 11:00am EDT

Presentation

11:00am EDT

CASE STUDY: FIVE BIO-EQUIVALENCE STUDIES DURING COVID

Health Authority Inspection Uncovered Critical Gaps in Quality and Forced Accelerated Re-Performance of Five Bioequivalence (BE) Studies During COVID

Discuss background of study and inspection of previous In-Vivo BE studies for already established products
- Gaps observed regarding efficacy and safety variables as well as data quality assurance
- Lack of CRO oversight during original study
Understand the corrective action plan and GCP challenges related to having to redo the studies in an expedited nature and during COVID
Evaluate preventive action and lessons learned

Speakers

Ahmed Bashtar

Quality Unit Lead, Dubai Hub, Middle East & Africa, BRISTOL-MYERS SQUIBB

Ahmed has ten years of experience in the pharmaceutical industry. He’sheld many posts in different fields e.g. R&D, quality control, quality assurance, Compliance auditing, supplier Quality Management, third parties Management, and supply chain management. He’s had experience... Read More →

Thursday April 8, 2021 11:00am - 11:30am EDT

Presentation

1:00pm EDT

EXCLUSIVE ACCESS: Vendor Oversight During the Pandemic

Understand how to Ensure and Document Effective Oversight of Vendors During The Pandemic and Beyond

Recognize the importance of having a formal vendor oversight plan and how that adapted during the pandemic
Share leading practices for effective documentation of remote vendor oversight during the pandemic
Understand sponsor requirements when it comes to oversight of vendor subcontractors and ensure subcontractors are qualified and monitored through effective oversight plans and documentation/communication with CRO

Speakers

Leslie M. Sam, BA, CSSBB

President, LESLIE SAM & ASSOCIATES, LLC

Accomplished, results-driven, passionate Clinical Research and Quality Professional with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →

Stacey Basham

Director, Clinical Quality Assurance, ABBVIE

Stacey Basham is currently Director, Clinical QA Audit and QA Vendor Management at AbbVie, Inc. in North Chicago, Illinois. In her role Stacey oversees GCP Vendor Quality assessment activities as well as supports clinical quality efforts for study activities across several therapeutic... Read More →

Thursday April 8, 2021 1:00pm - 1:30pm EDT

Presentation

1:30pm EDT

EXCLUSIVE ACCESS: Decentralized Trials

Discuss Pandemic-Driven Decentralized Trials and How to Build In Clinical Quality

Understand what decentralized means and how the pandemic accelerated adoption
Identify gaps in quality that could come from a decentralized approach
Discuss strategies for building in quality to proactively mitigate risk

Speakers

Laurie Berry, Ph.D., PMP

Director, Clinical Innovation & Strategic Partnerships, Global Product Development Operations COE, PFIZER

Laurie Berry, Ph D, PMP is Director, Clinical Innovation & Strategic Partnerships, in Pfizer’s Global Product Development Operations Center of Excellence. She is responsible for leading Pfizer’s Direct to Patient Initiative as part of the Pfizer’s Decentralized Clinical Trials... Read More →

Thursday April 8, 2021 1:30pm - 2:00pm EDT

Presentation