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11th Proactive GCP Compliance
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Monday, March 16
 

7:45am

8:30am

WORKSHOP A - DEFINE CLINICAL RISKS AND TOLERANCE THRESHOLDS
Identify Risks Related to Critical Processes and Data and Define Tolerance Limits  

  • Understand the elements of the protocol that are critical and impact subject safety and/or data integrity
  • Identify risks on both the system and trial levels
  • Evaluate the risks relate to critical process and data
  • Define study level tolerance for risk to establish thresholds  
  • Implement Quality Tolerance Limits (QTLs) and establish oversight during the trial
  • Model the components of GCP risk into an end to end approach

Speakers
avatar for Jonathan Rowe

Jonathan Rowe

Former Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER, aka The Clinical Risk Dude (Big GCP Lebowski)


Monday March 16, 2020 8:30am - 12:00pm

8:30am

WORKSHOP B - VENDOR OVERSIGHT
Ensure and Document Effective Oversight of Vendors Using Limited Resources 
  • Recognize the importance of having a formal vendor oversight plan
  • Share leading practices for effective documentation of vendor oversight
  • Discuss lessons learned in oversight when uncovering issues at CROs and other vendors
  • Understand sponsor requirements when it comes to oversight of vendor subcontractors
  • Ensure subcontractors are qualified and monitored through effective oversight plans and documentation/communication with CRO

Monday March 16, 2020 8:30am - 12:00pm

12:00pm

Lunch for Morning Workshop Participants
Monday March 16, 2020 12:00pm - 1:00pm

12:30pm

Registration for Afternoon Workshops
Monday March 16, 2020 12:30pm - 1:00pm

1:00pm

WORKSHOP C - TRIAL MASTER FILE
Develop and Maintain an Inspection-Ready Trial Master File (TMF)

  • Understand the purpose and value of a TMF
  • Define what an inspection-ready TMF means to different regulatory bodies
  • Evaluate how different regulatory agencies may interact with the TMF during an inspection
  • Assess the current state of your TMF to determine how to achieve inspection-ready status
  • Identify common areas of non-compliance
  • Develop an action plan to achieve and maintain that inspection-ready state

Speakers
avatar for Marion Mays

Marion Mays

Vice President, Expert Services and Consulting Solutions, PHLEXGLOBAL
Marion Mays in an industry leader in Information Management with over 25 years of experience in the Pharmaceutical industry.  An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the... Read More →


Monday March 16, 2020 1:00pm - 4:30pm

1:00pm

WORKSHOP D - PROACTIVE RISK MANAGEMENT AT EMERGING COMPANIES
Implement R2 Compliant Risk Management Approaches With Limited Resources

  • Outline the critical factors of ICH E6 R2 that changed the risk management approach
  • Examine how risk management has been modernized in response to ICH E6 R2
  • 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

Speakers
avatar for Shelly Weeks-Townsend, M.S., CQA

Shelly Weeks-Townsend, M.S., CQA

Director, Quality Assurance, ZYNERBA PHARMACEUTICALS
Shelly Weeks-Townsend is the Director of Quality Assurance at Zynerba Pharmaceuticals. Shelly has worked in the pharmaceutical industry for more than 27 years with experience spanning from bench chemist through product launch and post marketing surveillance. Over the past year with... Read More →
avatar for Dawn M. Niccum, M.S., RN PMP, CCRA RQAP-GCP

Dawn M. Niccum, M.S., RN PMP, CCRA RQAP-GCP

Senior Director, Quality Assurance 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 →


Monday March 16, 2020 1:00pm - 4:30pm
 
Tuesday, March 17
 

8:00am

8:45am

Chairperson's Welcome and Opening Remarks
Speakers
avatar for Joanne Spallone

Joanne Spallone

Global Development Quality Audit Head, NOVARTIS


Tuesday March 17, 2020 8:45am - 9:15am

9:15am

SENIOR LEADERS PANEL - Building Next Level Organizations
Moving An Organization To An Optimized State of Proactive Risk Management  

  • Create an organization that integrates skills to optimize processes, systems, and tools to work faster and smarter
  • Identify new skillsets that accelerate proactive risk management
  • Eliminate silos and motivate teams to think differently
  • Discuss how to drive operational change


Speakers
SC

Sharon Crugnale

Executive Director, Head of Clinical Operations, SAREPTA THERAPEUTICS
TW

Theresa Wingrove, Ph.D.

Senior Vice President, Regulatory Affairs and Quality, IMMUNOGEN
avatar for Beatrice Anduze-Faris

Beatrice Anduze-Faris

Vice President, Global Clinical Compliance and Continuous Improvement, BRISTOL-MYERS SQUIBB
Beatrice Anduze-Faris earner her Medical Degree from the Pierre and Marie Curie University Medical School in Paris, France, and spent several years in the Infectious Disease Unit of the Pitié-Salpétrière Hospital as a clinician, clinical investigator and clinical monitor. She has... Read More →
avatar for Sheila Gwizdak, MS

Sheila Gwizdak, MS

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 March 17, 2020 9:15am - 10:15am

10:15am

Networking Break in the Exhibit Area
Tuesday March 17, 2020 10:15am - 10:45am

10:45am

CASE STUDY - The Shift To A Quality Culture
Journey Through the Shift from a Reactive to an R2 Compliant Proactive Risk Management Approach and Culture of Quality 

  • Define culture of quality for your company
  • Monetize the risks of not having a culture of quality to obtain senior leadership buy-in
  • Develop a plan and educate internal and external stakeholders
  • Determine what this transition looks like and where to begin
  • Implement a long-term strategy and develop effectiveness checks to showcase success

Speakers
avatar for Kathleen L. O'Donnell, BSN

Kathleen L. O'Donnell, BSN

Head, Global R&D Clinical QMS Process Improvement, BRISTOL-MYERS SQUIBB
Kathleen L. O’Donnell, BSN, has more than 25 years of experience in regulatory affairs, clinical oncology, and strategy development within the biopharmaceutical industry - from beginning her career in oncology, including Gynecological Oncology and as Coordinator of the Breast and... Read More →


Tuesday March 17, 2020 10:45am - 11:30am

11:30am

PANEL DISCUSSION - The Latest Inspection Buzz
Share Observations and Lessons Learned From Recent Inspection Experiences and What This Means For Your Inspection Preparations  

  • Evaluate recent inspection experiences and observed trends 
  • Assess how inspections have changed regarding what inspectors expect and require
  • Identify common obstacles and challenges during an inspection and strategies for overcoming them
  • Outline best practices for managing expectations and preparation strategies

Tuesday March 17, 2020 11:30am - 12:30pm

12:30pm

Lunch
Tuesday March 17, 2020 12:30pm - 1:30pm

1:30pm

TRACK A - PANEL DISCUSSION - Clinical Data Integrity
Outline a Practical and Feasible Approach for Optimizing Clinical Data Integrity 

  • Discuss the importance of clinical data integrity and how it related to data quality 
  • Address the myth that ensuring clinical data integrity is a difficult, time and resource draining process 
  • Set and deploy a data and analytics vision
  • Evaluate how to further data accessibility and democratize the data
  • Build a data culture  

Speakers
avatar for Craig Mooney

Craig Mooney

Director, IRT, BRISTOL-MYERS SQUIBB
TV

Tom Verish

Senior Director, Global Data Strategy and Innovation, CSL BEHRING
avatar for Todd Johnson

Todd Johnson

Principal Consultant, HALLORAN CONSULTING GROUP
Todd Johnson has more than 20 years of experience in pharmaceutical development and clinical systems – from beginning his career as a clinical site monitor to developing operational performance dashboards and KPI/data reporting strategies. Having successfully managed clinical programs... Read More →


Tuesday March 17, 2020 1:30pm - 2:15pm

1:30pm

TRACK B - RISK-BASED MONITORING
Develop an Integrated Strategic Monitoring Plan to Realize the Benefits of Risk Assessment and Data Driven Monitoring
  • Discuss ICH E6 R2 and what a compliant monitoring strategy looks like
  • Understand the relationship between risk assessment data and the monitoring plan
  • Define the data journey and how different monitoring types impact data quality
  • Evaluate the evolution of the strategic monitoring plan during study execution
  • Optimize resources to drive efficiency through appropriate monitoring approaches and frequency  

Speakers
avatar for Duncan Hall

Duncan Hall

Chief Executive Officer and Founder, TRIUMPH RESEARCH INTELLIGENCE (TRI)
Duncan founded TRI with the vision of making R2 compliance and risk-based quality management accessible, affordable and operational for any organisation running clinical trials, large or small.Duncan has worked in the life sciences industry for more than 20 years and has consulted... Read More →


Tuesday March 17, 2020 1:30pm - 2:15pm

2:15pm

TRACK A - BUILD A RISK LIBRARY
Categorize Risk Data to Build a Cross-Study and Cross-Functional View of Trends and Enable Better Decision Making
  • Understand the purpose of a risk library, how it was accomplished and how it’s being used
  • Recognize the realized benefits of having a risk library through case study examples
  • Outline the steps to create your own risk library regardless of company size
  • Evaluate examples of risks that were identified using a risk library and what lessons were learned

Speakers
avatar for Steven Lang, MBA, PMP

Steven Lang, MBA, PMP

Director, Xcellerate Customer Success, COVANCE
Steven brings 14 years of experience in various project management and trial management capacities to his role of Director for the implementation and adoption of the Covance Xcellerate® Informatics suite.  Steven leads the development and advancement of the Xcellerate Risk and Issue... Read More →


Tuesday March 17, 2020 2:15pm - 3:00pm

2:15pm

TRACK B - OVERSIGHT OPTIMIZATION
Leverage Processes, Tools and Standardization to Optimize Oversight and Proactively Ensure Compliance 
  • Gain insight into how eTMFs can relieve old process burdens, identify problem areas and address quality issues
  • Discover how risk-based systems impact oversight
  • Discuss artificial intelligence and how it can be used to optimize oversight  
  • Review ideas on how to standardize oversight processes

Speakers
avatar for Louis Pasquale

Louis Pasquale

Director, Customer Success, IQVIA
Lou manages Customer Success for the Content Management group and is the Program Director for our eTMF, SiteZone, eArchive and eReg Implementations. With over 25 years’ experience in life sciences, Lou’s strengths lie in in the areas of SaaS implementation and delivery, information... Read More →


Tuesday March 17, 2020 2:15pm - 3:00pm

3:00pm

Networking Break in Exhibit Area
Tuesday March 17, 2020 3:00pm - 3:30pm

3:30pm

PANEL DISCUSSION - CRO Perspective
Discuss Effective Strategies for Ensuring Quality at the CRO-Level and Overcome Common Issues That Can Negatively Impact Proactive Risk Management  

  • Share different CRO oversight approaches and weigh the pros and cons  
  • Discuss strategies to avoid turnover or how to better manage turnover to maintain quality
  • Evaluate the use of the CRO’s tools and technology versus the sponsor’s tools and technology
  • Address the sharing of CRO SOPs with the trial sponsor
  • Advice from CROs to trial sponsors on how to optimize clinical quality and achieve effective proactive risk management

Speakers
VC

Vanesa Castillo

Senior Director, Monitoring and Data Flow Optimization, COVANCE
avatar for Liz Wool

Liz Wool

Managing Expert, Quality Center of Excellence, YOUR ENCORE
With 37 years in healthcare and 25 years in clinical research, Liz is a recognized industry expert, consultant and international speaker with a focus on solutions and added value results for her clients. Liz’s expertise is in the areas of clinical research, trial management, clinical... Read More →


Tuesday March 17, 2020 3:30pm - 4:30pm

4:30pm

ROUNDTABLE DISCUSSIONS
Each conference participant selects one topic from the following list to discuss in an intimate setting.  You’ll be asked for your topic selections via email a few weeks out from the conference and will have the opportunity to also sign up onsite.
  1. MEASURE RISK: Define Critical Quality Factors and Metrics to Accurately Assess Risk
  2. EFFECTIVENESS CHECKS:  Manage Issue Resolution to Mitigate Risk by Preventing Future Occurrences 
  3. QUALITY AGREEMENTS: Understand the Purpose of a Quality Agreement and How It Differs From a Contract
  4. QUALITY MANAGEMENT PLANS: Outline the Critical Factors of an Effective Quality Management Plan
  5. GLOBAL REGULATORY INSPECTIONS:  Navigate the Global Regulatory Challenges and Changing Landscape for Inspections 

Tuesday March 17, 2020 4:30pm - 5:15pm

5:15pm

 
Wednesday, March 18
 

8:00am

8:45am

Chairperson's Opening and Recap of Previous Day
Speakers
avatar for Joanne Spallone

Joanne Spallone

Global Development Quality Audit Head, NOVARTIS


Wednesday March 18, 2020 8:45am - 9:00am

9:00am

PANEL DISCUSSION - Risk Management Tools
Evaluate Various Systems, Tools and Processes That Have Proven Effective for  Proactively Measuring, Tracking and Managing Clinical Risk 

  • Share what’s worked and what hasn’t to measure, manage and track risk in clinical operations
    • Leverage the trial master file as a risk management tool
    • Understand how audits can be used to assess risk management
  • Review effective strategies for leveraging a quality management system to proactively identify risk

Speakers
avatar for Michael Wieczerzak, MS, MBA, CCRP

Michael Wieczerzak, MS, MBA, CCRP

Associate Director, Clinical Quality Management, 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 →


Wednesday March 18, 2020 9:00am - 10:00am

10:00am

Networking Break in Exhibit Area
Wednesday March 18, 2020 10:00am - 10:30am

10:30am

TRACK A - SMALL BIOTECH CASE STUDY - GCP Quality Risk Management
Implement GCP Risk Assessments for Clinical Protocols and Trial Execution That Align with ICH E6 R2 

  • Examine the approach taken to create standard processes and tools that align with ICH E6 R2
    • Discuss the creation of SOPs and tool development
    • Identify and manage all stakeholders throughout the development process
    • Work with CROs to ensure they are on board with any changes
    • Share how the program was implemented and the necessary training
  • Outline the challenges, obstacles, lessons learned and best practices

Speakers
avatar for Angela Repa

Angela Repa

Director, Proactive Clinical Excellence, BLUEBIRD BIO
Angela is an experienced quality and compliance professional with over 18 years of experience in the pharmaceutical and biotech industry.  She is currently Director of Proactive Clinical Excellence at bluebird bio.  bluebird is building integrated product platforms that encomp... Read More →
avatar for Alicia Wolny

Alicia Wolny

Senior Manager, Inspection and Risk Management, BLUEBIRD BIO
Alicia has over 12 years of experience in the pharmaceutical and biotech industry. The focus of her career has been on process improvement, training, and inspection readiness. She is currently overseeing Clinical inspection readiness and risk management activities as a Senior Manager... Read More →


Wednesday March 18, 2020 10:30am - 11:30am

10:30am

TRACK B CASE STUDY - TRAINING THE NEXT GENERATION OF QUALITY PROFESSIONALS
Develop a Training and Auditing Program to Ensure our Quality Professionals Can Identify Quality Issues That Matter
  • Evaluate your audit data to determine what signals it is (or is not) providing
  • Understand why traditional sampling and audit approaches may no longer work
  • Set the tone for change in your organization
  • 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
  • Evolve your quality program to focus on quality issues that matter

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

Sharon S. Reinhard, M.S.

Executive Director, MRL Quality Assurance, Strategy and Business Operations, MERCK
Sharon Reinhardhas over 20 years of industry experience comprised of a unique blend of roles in clinical development, operations, compliance and quality assurance.She has worked for large companies such as Wyeth, mid-sized companies such as Shire and Endo and small biotech companies... Read More →
avatar for Laura Herbein

Laura Herbein

Associate Director, MRL Quality Assurance, Strategy and Business Operations, MERCK


Wednesday March 18, 2020 10:30am - 11:30am

11:30am

TRACK A - QUALITY BY DESIGN
Review 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 Crissy MacDonald, Ph.D.

Crissy MacDonald, Ph.D.

Executive Director, Client Delivery, THE AVOCA GROUP
As leader of the Avoca Group’s Integrated Consulting, Crissy MacDonald provides consulting to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience... Read More →


Wednesday March 18, 2020 11:30am - 12:15pm

11:30am

TRACK B - SITE REGULATORY DOCUMENTATION QUALITY
Discuss the Automation of Essential Site Documentation Review to Optimize Quality and Avoid Common Issues
  • Evaluate the inefficiencies of the current manual process of site document review
  • Outline efficiencies to be gained 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

Speakers
avatar for JT Tan

JT Tan

Sponsor/CRO Innovation Lead, COMPLION
JT Tan is the Sponsor/CRO Innovation Lead at Complion. With a BS in Biology and an MS in Entrepreneurial Biotechnology,  as well as his work as a research assistant in Behavioral Neurobiology, JT is well suited to contribute to Complion’s mission to transform the way clinical trial... Read More →


Wednesday March 18, 2020 11:30am - 12:15pm

12:15pm

Lunch
Wednesday March 18, 2020 12:15pm - 1:15pm

1:15pm

CASE STUDY - Quality Data Analytics
Leverage Clinical Research and Regulatory Data to Proactively Identify Quality Trends and Optimize Operations 

  • Define the motivation for change
  • Discuss the initial opportunities for data quality analytics
  • Formalize the analytics program across functions and organizations
  • Evaluate IT/technology considerations and investments
  • Examine how to use data marts and data standardization
  • Share the long term vision and lessons learned during this journey

Speakers
avatar for MyLe Hoang

MyLe Hoang

Director, Quality Assurance, Infectious Disease/Vaccines, MERCK
MyLe Hoang has 20 years of experience in the pharmaceutical industry across various therapeutic areas with in depth knowledge in clinical data management, trial management, clinical operations, process and quality management, GCP auditing and GCP inspections. MyLe is currently a director... Read More →
avatar for Daniel Khordi

Daniel Khordi

Executive Director, Technology and Vendor QA, MERCK
Daniel Khordi has 20 years of experience in the pharmaceutical industry across both clinical research and manufacturing with in depth knowledge in GxP Quality, Computer Validation, IT, Manufacturing Automation, technologies used in Clinical Trials, and Quality Analytics.Daniel is... Read More →


Wednesday March 18, 2020 1:15pm - 2:00pm

2:00pm

PANEL DISCUSSION - Clinical Trial Conduct Quality Issues
Identify Best Practices for Handling Quality Issues Related to the Conduct of Clinical Trials, Such as Serious Breach and Privacy 
  • Discuss the most common quality issues found at the site-level
  • Evaluate how these issues are identified
  • Determine what qualifies as serious breach and actions that must be taken 
  • Examine proactive approaches to avoid these issues

Speakers
avatar for Maryann Livolsi, MSN, RN

Maryann Livolsi, MSN, RN

Senior Director, GCP Quality Assurance, BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE
Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized, large pharmaceutical/bio-pharmaceutical and a non-profit bio-pharmaceutical company, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP... Read More →


Wednesday March 18, 2020 2:00pm - 3:00pm

3:00pm

Chairperson's Concluding Remarks
Speakers
avatar for Joanne Spallone

Joanne Spallone

Global Development Quality Audit Head, NOVARTIS


Wednesday March 18, 2020 3:00pm - 3:15pm