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Proactive GCP Compliance 2021
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Monday, June 21
 

9:30am EDT

Virtual Environment Opens
Come Explore and Network!  
  • Explore the partner hall to understand how leading service providers are helping their clients through this challenging time
  • Catch up with colleagues in our networking lounge
  • Engage with your peers through one-on-one video and text chat 
  • Collect white papers and resources in our Resource Center
  • View the agenda in the Theater and make sure your favorite sessions are added to your calendar so you won't miss them!
  • Earn points and prizes for being top engagers and top networkers over the three days of the event

Monday June 21, 2021 9:30am - 10:00am EDT

10:00am EDT

Conference Welcome
Speakers
avatar for Sharon Reinhard, M.S.

Sharon Reinhard, M.S.

Vice President, Global Quality, AVROBIO
Experienced pharmaceutical executive with 23 years of industry experience, currently Vice President of Global Quality at AVROBIO, a gene therapy company based in Cambridge, with responsibility across all GXPs.   Previously served as Vice President of R&D Quality with CSL Behring... Read More →


Monday June 21, 2021 10:00am - 10:15am EDT

10:15am EDT

KEYNOTE: Recognizing the Inflection Point
How Data and Predictive Analytics are Modernizing R&D Quality 
  • Understand the potential of data and predictive analytics
  • Harness the power of unstructured data to enable Predictive Modeling and derive Business Value from Audit and Inspection Data
  • Beyond upskilling: Build a culture and environment that enables the digital upskilling journey

Speakers
avatar for Federico Feldstein, J.D.

Federico Feldstein, J.D.

Vice President, Head of BioResearch Quality and Compliance, JOHNSON & JOHNSON
Federico Feldstein currently leads the BioResearch Quality & Compliance (BRQC) organization across the three sectors (Pharmaceutical, Medical Device, Consumer Health) at Johnson & Johnson. He is a member of the Johnson & Johnson Quality & Compliance Leadership Team, Janssen Quality... Read More →


Monday June 21, 2021 10:15am - 10:45am EDT

10:45am EDT

SENIOR LEADERS PANEL: Clinical Quality Post-Pandemic
Discuss the Impact of the Pandemic on Quality Culture and Operations 
  • How did your company’s culture of quality play a role during the pandemic?
  • Examine the rapid adaptation of processes resulting from the pandemic and the possible implications for R&D quality
  • Identify new best practices learned during the pandemic that are here to stay  

Speakers
avatar for Jonathan Taylor

Jonathan Taylor

Vice President, Global Head Product Development Quality, ROCHE/GENENTECH
Over 20 years Quality Assurance experience (GLP, GCPv, GCP, PV) for major pharmaceutical and contract research companies.  Senior Management and Global Leadership Team experience.Experienced in conducting Investigator site, document, database, internal system, CRO, clinical laboratory... Read More →
avatar for Kristel Van de Voorde

Kristel Van de Voorde

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 →
avatar for Sharon Reinhard, M.S.

Sharon Reinhard, M.S.

Vice President, Global Quality, AVROBIO
Experienced pharmaceutical executive with 23 years of industry experience, currently Vice President of Global Quality at AVROBIO, a gene therapy company based in Cambridge, with responsibility across all GXPs.   Previously served as Vice President of R&D Quality with CSL Behring... Read More →
avatar for Peter Alain

Peter Alain

Vice President, Clinical Quality Assurance, ASTELLAS
Peter Alain has more than 35 years of experience in Quality within the pharmaceutical industry. He is currently the Global Head of Clinical Quality Assurance (CQA) within Astellas’ Medical and Development division and is a member of the Quality Assurance Leadership Team. In this... Read More →


Monday June 21, 2021 10:45am - 11:45am EDT

11:45am 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.

Monday June 21, 2021 11:45am - 12:00pm EDT

12:00pm EDT

DATA QUALITY AND PATIENT SAFETY
Optimize the Monitoring of Patient Safety Data to Effectively Uncover any Quality Issues 
    • Recognize that often patient safety monitoring methodologies are manual or primitive and must evolve
    • Understand what quality issues can be identified through effective monitoring of patient safety data
    • Discuss strategies for improving collection, review and communication of patient safety and data quality issues

Speakers
avatar for Praveen Kumar

Praveen Kumar

Senior Director, Medical Data Review, Drug Safety, COVANCE
Praveen Kumar is the Senior Director, Central Monitoring & Medical Data Review for Covance by Labcorp and based in Bangalore, India. Praveen has done his Master’s in science and has extensive work experience in the field of Clinical Research, Risk Based Monitoring and Data Management.He... Read More →
avatar for Naveen KK

Naveen KK

Head of RBM and Drug Safety, COVANCE
Dr. Naveen K.K. is the Executive Director & Global Head of Central Monitoring, Medical Data Review & Safety Solutions for Covance by Labcorp and based in Bangalore, India. He has more than a decade of Clinical research experience, and has worked across India, China, Japan and US as... Read More →


Monday June 21, 2021 12:00pm - 12:30pm EDT

12:30pm EDT

SMALL COMPANY CASE STUDY: Iterative Approach to Risk Management
How to Take Baby Steps Towards R2 Compliance  
  • Where to start: Outline practical quality strategy and tactics to get up to speed in an E6(R2) world
  • Define the approach (e.g., catalogue available tools and simplify)
  • Start small at first (e.g., isolate a few most important risks and triage)
  • Focus on your areas of personal influence (e.g., find proactive ways that you can improve the risk profile)
  • Calibrate (e.g., with cross-functional teams)
  • Learn, Improve, and Expand


Speakers
avatar for Tim Stoddard

Tim Stoddard

Senior Director, Clinical Quality Leader, SPARK THERAPEUTICS, INC.
Tim Stoddard has 18 years of broad quality experience in research (clinical, non-clinical, pharmacovigilance, real-world evidence), therapy development (drugs, biologics, cell & gene therapies, combination products, medical devices), technology (software development, computer systems... Read More →


Monday June 21, 2021 12:30pm - 1:00pm EDT

1:00pm EDT

Networking Break - Engage with our Partners, Hang out in the Networking Lounge, Video Chat with Peers and More!
This is designated staffed booth time, so if you have questions, want to earn points for prizes, or are just wanting to talk to someone (remote working can get lonely) head over to our virtual partner hall and talk to your friendly and knowledgeable colleagues.

STRATEGIC NOTE: Clinical Partners often have the complete cross-sectional industry view of how different companies are handling specific issues brought on by the pandemic. Pick their brains for suggestions and advice on how to make your job easier. 

Monday June 21, 2021 1:00pm - 2:00pm EDT

2:00pm EDT

eTMF AS AN OVERSIGHT TOOL
Leverage the eTMF as Evidence of GCP Compliance Across Partners 
  • Discuss ICH-GCP as it relates to the TMF and what evidence needs to be demonstrated in the eTMF/TMF
  • Evaluate where this evidence should be within the TMF and that it’s accessible for all relevant parties
  • Understand each stakeholder’s responsibility for compliance and how a TMF can show this
  • Outline case study examples demonstrating how the eTMF was used effectively to oversee partner compliance

Speakers
avatar for Darshan Patel

Darshan Patel

Customer Success Leader, IQVIA
Darshan Patel is a Customer Success leader for IQVIA eTMF systems. He is responsible for client relationships, training needs, system upgrades and migrations. Darshan has significant clinical experience in both CRO and sponsor settings, in several GXP environments. He has focused... Read More →


Monday June 21, 2021 2:00pm - 2:30pm EDT

2:30pm EDT

PANEL DISCUSSION: Proactive Clinical Risk Management
Examine the Critical Elements of Success for A Truly Proactive Clinical Risk Management Approach 
  • Recognize the importance of a data culture and where to start
  • Identify the elements of operational disruption with critical impacts to data integrity
  • Discuss mitigation approaches and requirements from Regulatory Agencies
  • Walk through examples of problems and mitigation recommendations

Speakers
avatar for Loreena Sadowski

Loreena Sadowski

Regional Clinical Compliance Head, Americas, BRISTOL MYERS SQUIBB
avatar for Michele Weitz

Michele Weitz

Senior Director, Clinical 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 →
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 →


Monday June 21, 2021 2:30pm - 3:30pm EDT

3:30pm EDT

Roundtable Discussions - Engage in Face-to-Face in this Video Discussion (NOT RECORDED, MUST ATTEND LIVE)
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.

Roundtable #1:  Site Quality Visit Survival Skills Learned During a Pandemic
  • Bring your success stories, your nightmares, your challenges and your questions on how your peers handled site visits over the last 15 months
  • How do pre-pandemic site visits compare to what we anticipate seeing post-pandemic?  What changes are you preparing for?

Roundtable #2: TBD

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.  

Speakers
avatar for Darshan Patel

Darshan Patel

Customer Success Leader, IQVIA
Darshan Patel is a Customer Success leader for IQVIA eTMF systems. He is responsible for client relationships, training needs, system upgrades and migrations. Darshan has significant clinical experience in both CRO and sponsor settings, in several GXP environments. He has focused... Read More →
avatar for Lou Pasquale

Lou Pasquale

Director, eTMF Delivery, IQVIA


Monday June 21, 2021 3:30pm - 4:15pm EDT

4:15pm EDT

Close of Day One Live Sessions - Virtual Environment Remains Open
  • This marks the conclusion of our live content for the day
  • The virtual environment remains open and accessible so you can download materials and view on-demand presentations at your leisure
  • Check out the “Who’s Here” to see if any of your colleagues attended today and consider reaching out to them and setting up a time to virtual chat during one of the upcoming networking breaks at the event!  

Monday June 21, 2021 4:15pm - 4:15pm EDT
 
Tuesday, June 22
 

10:00am EDT

Welcome From Today's Conference Chair
  • Meet today's esteemed Chair who will guide us through today's educational content 


Speakers
avatar for Kerstin Koenig, Ph.D.

Kerstin Koenig, Ph.D.

Vice President, Global Head Research & Development Quality, BRISTOL MYERS SQUIBB
Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol-Myers Squibb Company. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance activities the area of Product Development Quality, Good Laboratory Practice... Read More →


Tuesday June 22, 2021 10:00am - 10:15am EDT

10:15am EDT

MERCK CASE STUDIES: REMOTE QA BEST PRACTICES
Proven Methodologies and Important Considerations from Case Studies of Remote Audits 
  • Learn from Merck’s recent experiences with remote site audits and remote study-level audits
  • Discuss the challenges identified and how they were overcome
  • Share best practices and process improvements going forward 

Speakers
avatar for Jamie Bridges

Jamie Bridges

Executive Director, Infectious Disease and Vaccines Quality Assurance, MERCK
Jamie Bridges has 23 years of pharmaceutical experience. She began her career at Pfizer and spent the past 22 years with Merck based out of West Point, PA.  Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →


Tuesday June 22, 2021 10:15am - 10:45am EDT

10:45am EDT

Q&A With Morning Speaker
Tuesday June 22, 2021 10:45am - 11:00am EDT

11:00am 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.

Tuesday June 22, 2021 11:00am - 12:00pm EDT

12:00pm EDT

QUALITY BY DESIGN
Discuss Quality by Design and Proactive Quality Management As a Vehicle for Clinical Trial Modernization and ICH E8 (R1) Compliance 
  • Discuss Section 3 of ICH E8 (R1) focusing on proactive quality by design, including:
  • Identify and manage critical to quality factors (CTQs)
  • Establish and nurture a quality culture
  • Incorporate stakeholder feedback (including patient and caregiver) into trial design
  • Evaluate how the above factors can have a positive effect on quality outcomes for the trial

Speakers
avatar for Sameera Ibrahim T.

Sameera Ibrahim T.

Head, R&D Quality Strategy & Business Operations, Global R&D Quality, BRISTOL MYERS SQUIBB
Sameera is a Biochemist by training with over 17 years of experience in the pharmaceutical industry. She is a Quality Assurance auditor with extensive experience in Good Clinical Practise (GCP) and Good Pharmacovigilance Practice (GVP). She currently heads up the Quality Strategy... Read More →


Tuesday June 22, 2021 12:00pm - 12:30pm EDT

12:30pm EDT

FIRESIDE CHAT: CLINICAL DATA INTEGRITY
Prove Clinical Data Integrity During the Operational Disruption Caused by the Pandemic 
  • Recognize the importance of a data culture and where to start
  • Identify the elements of operational disruption with critical impacts to data integrity
  • Discuss mitigation approaches and requirements from Regulatory Agencies
  • Walk through examples of problems and mitigation recommendations

Speakers
avatar for Karen Travers

Karen Travers

Senior Consultant, Technology Solutions, HALLORAN CONSULTING GROUP
Karen Travers has more than 20 years of experience in a variety of technologies supporting life sciences, particularly clinical operations and regulatory affairs and most recently developing wearable medical devices utilizing complex machine learning and AIs. Prior to joining Halloran... 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 →


Tuesday June 22, 2021 12:30pm - 1:00pm EDT

1:00pm EDT

Networking Break - Engage with our Partners, Hang out in the Networking Lounge, Video Chat with Peers and More!
This is designated staffed booth time, so if you have questions, want to earn points for prizes, or are just wanting to talk to someone (remote working can get lonely) head over to our virtual partner hall and talk to your friendly and knowledgeable colleagues.

STRATEGIC NOTE: Clinical Partners often have the complete cross-sectional industry view of how different companies are handling specific issues brought on by the pandemic. Pick their brains for suggestions and advice on how to make your job easier. 

Tuesday June 22, 2021 1:00pm - 2:00pm EDT

2:00pm EDT

PANEL DISCUSSION: Issue Identification and Escalation
Discuss Best Practices for Creating Open Communication Among Stakeholders Regarding Possible Compliance Issues 
  • Foster a transparent culture that is not based on fear  
  • Share strategies for celebrating early issue discovery rather than shaming 
  • Escalation plans and communication approaches when issues are identified 
  • Evaluate follow-up and effectiveness checks    


Speakers
avatar for Dawn Lundin

Dawn Lundin

Clinical Research Compliance Director, UNIVERSITY OF PENNSYLVANIA PERELMAN SCHOOL OF MEDICINE
Over 24 years of GxP experience from quality assurance and compliance roles within both industry and academia. Current head of compliance for the Perelman School of Medicine and Director of the Quality Assurance Graduate Program of Study for the University of Pennsylvania. Previous... Read More →
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Senior Director, Clinical Quality Assurance, ASTELLAS
Michael Torok has over 20 years of experience in pharmaceutical development and has held leadership roles in Clinical Operations, Project and Portfolio Management, and Contracts and Outsourcing.  After completing coursework in data analytics and machine learning, Michael transitioned... Read More →
avatar for Liz Bodi, M.S., RQAP-GCP

Liz Bodi, M.S., RQAP-GCP

Principal Consultant, Quality, HALLORAN CONSULTING GROUP
Elizabeth Bodi has over 29 years of experience in the biopharmaceutical and medical device industry. Her career has focused primarily on clinical operations and clinical quality assurance activities to ensure excellence and consistency across phase I-V clinical trials. Elizabeth also... Read More →
avatar for Celeste Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical... Read More →


Tuesday June 22, 2021 2:00pm - 3:00pm EDT
 
Wednesday, June 23
 

10:00am 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.  

Wednesday June 23, 2021 10:00am - 10:00am EDT

10:30am EDT

10:45am EDT

PANEL DISCUSSION: GCP 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

Speakers
avatar for Michael Wieczerzak

Michael Wieczerzak

Associate Director, Clinical Quality Management Lead, EMD SERONO
Michael Wieczerzak is an Associate Director, Clinical Quality Management at EMD Serono. His main responsibilities are within inspection readiness and quality risk management. Prior to joining the Clinical Quality Management department, he was a Clinical Trial Lead running immunology... Read More →
avatar for Dawn Lundin

Dawn Lundin

Clinical Research Compliance Director, UNIVERSITY OF PENNSYLVANIA PERELMAN SCHOOL OF MEDICINE
Over 24 years of GxP experience from quality assurance and compliance roles within both industry and academia. Current head of compliance for the Perelman School of Medicine and Director of the Quality Assurance Graduate Program of Study for the University of Pennsylvania. Previous... Read More →
avatar for Joanne Spallone

Joanne Spallone

Former Senior GCP Officer, NOVARTIS
Joanne Spallone has worked in the pharmaceutical industry for over 40 years having spent most of that time in the Clinical Quality field.   She worked for CIBA-GEIGY/Novartis for 40 years and held varying roles within Research and Development and Clinical Quality including the position... Read More →


Wednesday June 23, 2021 10:45am - 11:45am EDT

11:45am 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 June 23, 2021 11:45am - 12:00pm EDT

12:00pm EDT

FIRESIDE CHAT: COMPREHENSIVE 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

Speakers
avatar for Stephanie Haley

Stephanie Haley

Associate Director, CQA, ASTELLAS
Stephanie Haley has over 29 years of experience in pharmaceutical development which includes 21 years in Clinical Quality Assurance. Her professional experience also includes roles held in pre-clinical Histology, Data Management and Pharmacokinetics. Stephanie’s current role is... Read More →


Wednesday June 23, 2021 12:00pm - 12:30pm EDT

12:30pm EDT

PANEL DISCUSSION: ASSESS QUALITY COMPETENCE
Evaluate what Skills and Attributes Make for a Successful Clinical Quality Professional
  • Discuss how the role of a quality professional has evolved
  • Recognize the importance of a team of critical thinkers to drive your culture of quality
  • Change the mindset of quality professionals from “QCing” others work to strategic, risk-based thinking
  • Ensure your quality professionals are prepared to navigate a rapidly changing research environment

Speakers
avatar for Frances DeGannaro-Culver

Frances DeGannaro-Culver

President, FDC CONSULTING
Quality Leader with a career of hands-on experience within Clinical Quality Management in developing and implementing U.S. and International clinical programs and regulatory and quality strategies for R&D while operating in effectively dynamic environments. Provides strategic input... Read More →
avatar for Sharon Reinhard, M.S.

Sharon Reinhard, M.S.

Vice President, Global Quality, AVROBIO
Experienced pharmaceutical executive with 23 years of industry experience, currently Vice President of Global Quality at AVROBIO, a gene therapy company based in Cambridge, with responsibility across all GXPs.   Previously served as Vice President of R&D Quality with CSL Behring... Read More →
avatar for Tim Stoddard

Tim Stoddard

Senior Director, Clinical Quality Leader, SPARK THERAPEUTICS, INC.
Tim Stoddard has 18 years of broad quality experience in research (clinical, non-clinical, pharmacovigilance, real-world evidence), therapy development (drugs, biologics, cell & gene therapies, combination products, medical devices), technology (software development, computer systems... Read More →
avatar for Michele Weitz

Michele Weitz

Senior Director, Clinical 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 →


Wednesday June 23, 2021 12:30pm - 1:30pm EDT

1:30pm EDT

Zoom Q&A with Speaking Faculty - Bring Your Burning Questions
You know what's missing from virtual events?  Face-to-face discussions.
You know what kind of scratches that itch? Zoom Q&A.

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.  

Wednesday June 23, 2021 1:30pm - 2:15pm EDT

2:15pm EDT

Live Conference Concludes
Access the Virtual Platform using your same login link, to view on-demand presentations and download materials for six months following the conference.  

Wednesday June 23, 2021 2:15pm - 2:15pm EDT
 
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