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Wednesday, April 7
 

8:00am EDT

Virtual Environment Opens, Come Explore and Network!
Navigate around our virtual environment to:
  • Catch up with colleagues and engage in in our networking lounge while discussing today’s hottest topics
  • Private text or video chat with fellow attendees, speakers and sponsors 
  • Collect valuable white papers and other clinical quality resources from our Content Hub
  • Peruse available job opportunities and post your own in our networking lounge
  • Add sessions to your agenda to ensure you don't miss any important content

Wednesday April 7, 2021 8:00am - 8:30am EDT

8:30am EDT

Chair's Welcome to the Day
Speakers
avatar for Kristel Van de Voorde

Kristel Van de Voorde

Vice President, Vice President, Global Clinical Quality and PV, BRISTOL-MYERS SQUIBB
Kristel Van de Voorde has 25 years of experience in the quality area in Bristol-Myers Squibb covering GCP, GPvP and interfaces in R&D with GLP and GMP. Currently, Kristel is the global head of the R&D quality function for clinical trials at Bristol-Myers Squibb. Kristel has set up... Read More →


Wednesday April 7, 2021 8:30am - 8:45am EDT

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
avatar for Paul Houri

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

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
avatar for David Hadden

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

9:45am EDT

Q&A With Previous Speakers
  

Wednesday April 7, 2021 9:45am - 10:00am EDT

10:00am EDT

Energizer Break
Let's get moving in between sessions to prepare our mind and our body for optimal learning in the next sessions. Get some coffee, walk around, grab some fresh air and come back ready to focus.

Wednesday April 7, 2021 10:00am - 10:15am EDT

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
avatar for Nabil Girgis, MD, CQA

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 →
avatar for Dr. Hanna Preus

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 →
avatar for Sheila Gwizdak, M.S.

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 →
avatar for David Fryrear

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

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
avatar for Brigid Flanagan

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

11:45am EDT

Networking Break
  • Still have questions?  Head over to the networking lounge to chat with some of the speakers!   
  • Hiring?  Looking for a new job?  Check out the job postings in our networking lounge and feel free to post any positions from your own company.   


Wednesday April 7, 2021 11:45am - 1:00pm EDT

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
avatar for Jonathan Rowe

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

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
avatar for Sharon Reinhard

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 →
avatar for Bhausaheb Patil

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 →
avatar for Dawn Niccum

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 →
avatar for Kristin Stallcup

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 →
avatar for Kimberly Washburn

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

2:30pm EDT

ZOOM ROUNDTABLES: Grab a Cocktail!
You know what's missing from virtual events?  Face-to-face discussions.
You know what kind of scratches that itch? Zoom roundtables.

Get ready to turn on your camera and let people see you! Engage in an intimate and informal discussion around some of today's hottest topics. Bring your questions, best practices, lessons learned and let's discuss while unwinding after a productive day of sessions.

STRATEGIC NOTE:  What is said at the roundtable, stays at the roundtable.  These sessions are NOT recorded to optimize candid conversation and sharing, so you must participate LIVE to be part of these valuable discussions.  

Roundtable Topics:

Reimagine the Risk-Based Vendor Qualification Process 
The vendor qualification process is problematic, resulting in many wasted resources, especially time and money. Please join this discussion ready to share your challenging experiences so that we can work through the following solutions together:
  • Procedures to support the qualification process
  • Establishing evaluation criteria
  • Creating a clearly defined quality agreement
  • Developing vendor oversight protocol
  • Establishing audit procedures

Guideline Changes and COVID, Did They Raise the “Street Cred” of the Quality Risk Management Professional?
Come to this roundtable to discuss:
  • How proactive risk management has changed and how to overcome remaining barriers to implementation
  • The use of data to oversee quality and communicate risk to senior leadership
  • Setting risk tolerance and influencing quality culture


Wednesday April 7, 2021 2:30pm - 3:15pm EDT

3:15pm EDT

Day One Concludes
Our platform remains open so you can access the on-demand versions from all of the day’s presentations and download materials at your convenience.  

Wednesday April 7, 2021 3:15pm - 3:15pm EDT
 
Thursday, April 8
 

8:00am EDT

Virtual Environment Opens, Come Explore and Network
Navigate around our virtual environment to:
  • Catch up with colleagues and engage in in our networking lounge while discussing today’s hottest topics
  • Private text or video chat with fellow attendees, speakers and sponsors 
  • Collect valuable white papers and other clinical quality resources from our Content Hub
  • Peruse available job opportunities and post your own in our networking lounge
  • Add sessions to your agenda to ensure you don't miss any important content

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

8:30am EDT

Chair's Welcome To the Day
Speakers
avatar for David Fryrear

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 →


Thursday April 8, 2021 8:30am - 8:45am EDT

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
avatar for Mike Sobczyk

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 →
avatar for David M. Potter

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 →
avatar for David Fryrear

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 →
avatar for Michele Weitz

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

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
avatar for Carol Bognar

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

10:15am EDT

Energizer Break
Let's get moving in between sessions to prepare our mind and our body for optimal learning in the next sessions. Get some coffee, walk around, grab some fresh air and come back ready to focus.

Thursday April 8, 2021 10:15am - 10:30am EDT

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
avatar for Pearl Boayke

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

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
avatar for Ahmed Bashtar

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

11:45am EDT

Networking Break
  • Still have questions?  Head over to the networking lounge to chat with the some of the speakers! 
  • Hiring?  Looking for a new job?  Check out the job postings in our networking lounge and feel free to post any positions from your own company. 
  • Access the Content Hub to download a plethora of related resources

Thursday April 8, 2021 11:45am - 1:00pm EDT

1:00pm EDT

Advanced Content with Exclusive Access - Requires Separate Registration
We now begin the exclusive portion of our event.  Access to these sessions requires a separate paid registration.  If you are already registered for the conference as a complimentary attendee and would like to pay to add-on this portion of the content, you'll locate a link to do so in your registration confirmation email.  If you can't locate this email, have questions, or need any assistance, please contact Kristen Hunter at khunter@questex.com.  

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

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
avatar for Leslie M. Sam, BA, CSSBB

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 →
avatar for Stacey Basham

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

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
avatar for Laurie Berry, Ph.D., PMP

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

2:00pm EDT

EXCLUSIVE ACCESS: Zoom Q&A with Speakers - Grab a Cocktail and Bring All Your Unanswered Clinical Quality Questions
Join speakers and attendees for an intimate and informal discussion around some of today's hottest topics. Participants will vote on which topic(s) they want to discuss.  Bring your questions, best practices, lessons learned and let's discuss while unwinding after a productive day of sessions.

STRATEGIC NOTE:  This session is NOT recorded to optimize candid conversation and sharing, so you must participate LIVE to be part of these valuable discussions.  

Thursday April 8, 2021 2:00pm - 3:00pm EDT

3:00pm EDT

Conference Concludes
Our platform remains open and accessible for 6 months following the event, so you can access the on-demand versions from all of the day’s presentations and download materials at your convenience.  

Thursday April 8, 2021 3:00pm - 3:00pm EDT