GCP WEBCAST SERIES

How to Optimize Clinical Quality During a Global Pandemic

  JULY 7–9, 2020   VIRTUAL EVENT
 

Register Today Group

BROUGHT TO YOU BY

Fierce Pharma Logo

About

 

As the world adjusts to the new normal of a global pandemic, clinical research has continued to try and find a way to fight this virus. Ensuring trial integrity as processes and operations are disrupted by new safety mandates, poses significant challenges. We've developed a three-day event featuring perspectives from varying stakeholders as they share their experiences optimizing clinical quality during these trying times.

Registration is complimentary for professionals from pharmaceutical, biotech, and medical device organizations. Others are welcomed to register for a small fee which gives you full access to all three days. We anticipate this being an interactive live experience, so greatest value will come from being there the day of the event.

Thank you to our sponsors Group
July 7

TUESDAY, JULY 7
 

10:00AM EST
Expert Panel: How to Assure Clinical Quality During and Post-Covid

 

11:00AM EST
Case Study: Describe Risk Assessments for Continuing Clinical Studies During a Pandemic and Current Update on Their Status

July 8

WEDNESDAY, JULY 8
 

10:00AM EST
Training the Next Generation of Quality Professionals

 

11:00AM EST
Expert Panel: The Virtual Clinical World

July 9

THURSDAY, JULY 9
FOR SMALL AND EMERGING COMPANIES

 

10:00AM EST
Emerging Company Case Study: How to Pandemic Proof Your Clinical Trial

 

10:45AM EST
Clinical Trial Resilience And Efficiency

 

11:15AM EST
Site Regulatory Documentation Quality

1:00PM EST
Mid-Study Shift from Full SDV to Remote Risk-Based Monitoring

 

1:30PM EST
The New Monitoring Model

2:00PM EST
Panel Discussion: Proactive Risk Management at Emerging Companies

REGISTER FOR THIS FREE EVENT Group

AGENDA
TUESDAY, JULY 7

10:00AM-11:00AM
EXPERT PANEL: HOW TO ASSURE CLINICAL QUALITY DURING AND POST-COVID
Discuss What the “New Normal” Could Look Like for Clinical Trials and Strategies for Optimizing Quality in This Different Environment

  • Has COVID forever changed clinical trials?
  • What are effective approaches to assuring quality in the new environment?
  • What is an “audit” when entry to sites is banned and planes don’t fly?
  • Remote Audits – How can we do better than replicating the traditional site audit?
  • How can the new reality drive to truly paperless records?
  • How do we overcome the things “you have to see for yourself,” like informed consent, IMP integrity and accountability, and the paper site files?
fryear

MODERATOR
David Fryrear
Senior Vice President, Head of Clinical & Research Quality Assurance
ASTELLAS

Feldstein

Federico Feldstein, J.D.
Vice President, Head of BioResearch Quality and Compliance
JOHNSON & JOHNSON

Sheila

Sheila Gwizdak, M.S.
Vice President, Quality
HALLORAN CONSULTING GROUP

Spallon

Joanne Spallone
Senior Quality Officer, Global Development Quality
NOVARTIS

Saprin

Melissa Suprin
Head of Quality Risk Management, Clinical Development
PFIZER

11:00AM-12:00PM
CASE STUDY PRESENTATION
Determine Risk Assessments for Continuing Clinical Studies During a Pandemic and Current Update on Their Status

  • Understand the principles and objectives of risk-based approaches in clinical research
  • Learn strategies for engaging and orienting teams to the process
  • Delve into details of a clinical trials risk assessment during the COVID-19 pandemic
  • Consider initial outcomes from the risk assessment and the path forward
Weitz

Michele Weitz
Senior Director, Clinical Standards and Innovation
CLOVIS ONCOLOGY

Unger

Caro Unger
Clinical Operations
TELIOS PHARMA

AGENDA
WEDNESDAY, JULY 8

10:00AM-11:00AM
TRAINING THE NEXT GENERATION OF QUALITY PROFESSIONALS
Understand Why It’s More Important Than Ever to Develop Quality Professionals That Can Identify Quality Issues That Matter

  • Set the tone for change in your organization
  • Evaluate your audit data to determine what signals it is (or is not) providing
  • Identify what skills and attributes are needed from our quality professionals of the future
  • 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
reinhard

Sharon S. Reinhard, M.S.
Vice President, R&D QA
CSL BEHRING

11:00AM-12:00PM
EXPERT PANEL: THE VIRTUAL CLINICAL WORLD
Overcome Technology, Process and Behavior Barriers as We Shift to Virtual Trials and Remote Audits and Inspections

  • Discuss the impact of the global pandemic on clinical data, operations and people
  • Evaluate the sudden shift to virtual and remote technology options and the impact on clinical data integrity
  • Identify the process and conceptual obstacles to virtual and remote options and how to overcome them
  • Understand the site perspective and what is needed to facilitate efficient remote and virtual options
  • Strategize on technology options and solutions to streamline remote monitoring and virtual inspection
Lownie

MODERATOR
Ken Lownie
General Manager US
AGATHA

mccarthy

Cheryl McCarthy, CQA, CBA, RQAP-GCP
Director, Research Quality Assurance
IRONWOOD PHARMACEUTICALS 

Gonzalez

Celeste Gonzalez
Principal Specialist, Clinical Quality Assurance and Compliance
BOSTON SCIENTIFIC  

Heinz

Jill Heinz, MHS, CCRC, CRCP
President
FAMILY CARE RESEARCH and INJURY CARE RESEARCH

AGENDA
THURSDAY, JULY 9

10:00AM-10:45AM
EMERGING COMPANY CASE STUDY: HOW TO PANDEMIC PROOF YOUR CLINICAL TRIAL
Identify and Leverage Available Resources to Shift to a Study Model that Can Withstand a Pandemic

  • Learn from Palvella Therapeutics as they share their story of successfully pivoting their study to a functional model that can work during a pandemic
  • Understand when they took action in response to COVID-19
  • Discuss the use of home health providers, local testing facilities and telehealth capabilities
  • Evaluate which endpoints can be completed by the patient in their home or in their community
  • Examine how clinical trials will change moving forward
Goin

Kathy Goin
Vice President, Development Operations
PALVELLA THERAPEUTICS, INC.

10:45AM-11:15AM
CLINICAL TRIAL RESILIENCE AND EFFICIENCY  
Small Companies Can Survive the Lockdown and Future Proof Trials Post COVID-19

  • Accelerate decision making and documentation during lockdown
  • Optimize trials through risk assessment and strategic monitoring plans using available resources  
  • Reduce trial fragility and exposure to global events
Hall

Duncan Hall
Chief Executive Officer and Founder
TRIUMPH RESEARCH INTELLIGENCE (TRI)

11:15AM-11:45AM
SITE REGULATORY DOCUMENTATION QUALITY
Automate Remote Review of Essential Site Documentation to Optimize Quality During a Pandemic and Beyond

  • Evaluate the inefficiencies of the current manual process of site document review
  • Outline efficiencies to be gained and costs to be saved, with automated monitoring of site documentation
  • Develop a strategy for automation that involves all stakeholders
  • Share realized benefits from case studies of this new approach to quality control
Loch

Dylan Loch
Director, Industry Business Development
COMPLION

1:00PM-1:30PM
MID-STUDY SHIFT FROM FULL SDV TO REMOTE RISK-BASED MONITORING
Streamline the Transition from Full Source Data Verification (SDV) To A Risk-Based Approach

  • Evaluate and document the risks of the study
  • Determine the important components of a risk-based approach and the transition plan
  • Document and ensure inspection readiness
Stallcup

Kristin Stallcup
Senior Director, Xcellerate Customer Success
COVANCE 

Keenan

Gayle Keenan
Senior Manager, Xcellerate Customer Success
COVANCE 

1:30PM-2:00PM
THE NEW MONITORING MODEL
Utilize Resources Available to Small Companies to Conduct Remote Monitoring During COVID and Beyond

  • Identify what things need to take place to conduct remote monitoring
    • Evaluate the site’s remote monitoring readiness with an assessment checklist
    • Do they have external EMR access?
    • Discuss the necessity of a shared file area (SFA) platform
  • Determine what actions need to be taken to implement using available tools
  • Oversee and follow-through to ensure remote monitoring is effective
Gonzalez

Celeste Gonzalez
Principal Specialist, Clinical Quality Assurance and Compliance
BOSTON SCIENTIFIC  

2:00PM-3:00PM
PANEL DISCUSSION: PROACTIVE RISK MANAGEMENT AT EMERGING COMPANIES
Implement Compliant Risk Management Approaches With Limited Resources in a Remote/Virtual Clinical World

  • Understand how COVID-19 has impacted clinical risk management at companies with limited resources
  • Examine how risk management has been modernized in response to the pandemic
  • Leverage risk management to predict GCP risk and the impact on monitoring and auditing planning
  • Describe an approach for identifying important questions to ask about a protocol that can identify risk
Lazaro

Manny Lazaro
Vice President, Clinical Operations
JOUNCE THERAPEUTICS

Wool

Liz Wool
Managing Expert, Quality Center of Excellence
YOUR ENCORE

Krista

Krista Kerr
Director, Quality Management
CEREVEL THERAPEUTICS