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Monday, September 27
 

8:00am EDT

Registration and Breakfast in Exhibit Area
Monday September 27, 2021 8:00am - 8:30am EDT

8:30am EDT

WORKSHOP A: Quality Tolerance Limits
Demonstrate the Steps for Defining and Implementing Appropriate Quality Tolerance Limits (QTLs) Through Case Study Examples and Hands-On Learning

Review ICH E6 R2 requirements for quality management, inclusive of risk management
  • Define critical data and processes; what matters most to GCP
  • Differentiate systemic versus clinical trial level risks
  • Establish risk management fundamentals by identifying, evaluating and controlling risks
  • Understanding failure mode effects analysis
Deep Dive into Quality Tolerance Limits
  • Define QTLs, the underlying components, and understand their purpose
  • Differentiate QTLs from Key Risk Indicators (KRIs) and Risk-Based Monitoring (RBM)
  • Evaluate the requirements driving the development of QTLs
  • Understand how QTLs fit into an overarching risk management process
QTLs in Action
  • Learn about a QTL implementation journey
  • Discuss how to monitor QTLs
  • Practice developing QTLs in an interactive session
  • Outline the reporting of QTLS

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. In this... Read More →


Monday September 27, 2021 8:30am - 12:00pm EDT

8:30am EDT

WORKSHOP B: 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 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 →


Monday September 27, 2021 8:30am - 12:00pm EDT

12:00pm EDT

Lunch for Workshop Participants
Monday September 27, 2021 12:00pm - 1:00pm EDT

1:00pm EDT

WORKSHOP C: Clinical CAPA Flavors, Which is for You?
Explore the Different Levels of Clinical Corrective and Preventive Actions (CAPAs)  
In this workshop you will learn about the different levels of CAPAs and how to apply a methodology which is right for the level of CAPA sought.
  • Explore the base of all the flavors? --- It's vanilla! (The basic problem to be solved: a regulatory compliance issue.) 
  • Determine when different flavors make sense?--- Rocky Road may mean lots of moving parts to the root cause, correction, preventative action; whereas, Coffee may mean 1 moving part and a simple resolution: formal letter asking for action.
  • How to mix the batch to get the right flavor. Escalation of approaches.
  • Determine when just the base flavor will suffice.

Speakers
avatar for Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste M. 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 →


Monday September 27, 2021 1:00pm - 4:30pm EDT

1:00pm EDT

WORKSHOP D: Risk-Based Vendor Qualification
Reexamine and Revise the Risk-Based Vendor Qualification Process 
  • Recognize that the “standard” vendor qualification process is flawed
  • Discuss the criteria for a truly risk-based approach to vendor qualification
  • Identify the core procedures that are critical and support the qualification process
  • Establish effective evaluation criteria based on the needs of the study
  • Craft a clearly defined quality agreement
  • Develop a vendor oversight protocol
  • Establish preliminary and ongoing audit procedures

Monday September 27, 2021 1:00pm - 4:30pm EDT
 
Tuesday, September 28
 

8:00am EDT

Registration and Breakfast in Exhibit Hall
Tuesday September 28, 2021 8:00am - 8:30am EDT

8:30am EDT

Chairperson's Welcome and Industry Update
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 →


Tuesday September 28, 2021 8:30am - 9:00am EDT

9:00am EDT

KEYNOTE ADDRESS: Trust Through Transparency
Modernization of Quality as An Enabler of Industry Transformation
  • Examine the huge responsibility of Health Authorities to act as the proxy patient
  • Building trust through transparency to increase confidence in the industry’s process, efficacy and assurance
  • Accelerate innovation while maintaining compliance and assurance

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 →


Tuesday September 28, 2021 9:00am - 9:30am EDT

9:30am EDT

SENIOR LEADERS PANEL: Quality Vs. Business Needs
Examine the Delicate Balance Between Quality and Business Needs in Clinical Research 
  • Understand the necessity of the natural tensions between business needs and quality needs and how they are manifested in the clinical research space
  • Discuss how the pandemic broke down the silos between departments and what this transparency can mean for the relationship between business and quality
  • Evaluate the impact of a culture of quality on the push and pull between business and quality

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 →
avatar for Jessica Lee

Jessica Lee

Senior Vice President, Clinical Science and Operations and Global Integration, INOVIO PHARMACEUTICALS
Experienced Clinical Operations and Clinical Compliance executive with demonstrated success working in the biotechnology and pharmaceutical industries. Skilled in clinical systems, vaccines, oncology, gene therapy, medical devices and Good Clinical Practice across Phase 1-3. Strong... 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 Priya Chaturvedi, Ph.D.

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, EISAI
Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai inc. She has responsibility for Global Clinical Quality Assurance (CQA), Global Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director... Read More →


Tuesday September 28, 2021 9:30am - 10:30am EDT

10:30am EDT

Networking and Refreshment Break
Tuesday September 28, 2021 10:30am - 11:00am EDT

11:00am EDT

RISK-BASED AUDITING: Improving Resource Utilization and Issue Detection
Recognize Risk-Based Auditing As The Critical Element of Clinical Risk Management 
  • Why does risk-based auditing always take a back seat to risk-based monitoring?
  • Differentiate monitoring versus auditing requirements in the guidelines
  • Examine data sets that can be used for audit planning and risk-based auditing
  • Learn about model building for identifying sites at risk
  • Review NLP and AI use cases for audit findings

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. In this... Read More →


Tuesday September 28, 2021 11:00am - 11:30am EDT

11:30am EDT

REGULATORY UPDATE: FDA Inspections
Evaluate Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Compliance and Enforcement
  • Identify recent trends in CDER-BIMO compliance and enforcement, including inspections of clinical investigators and sponsors
  • Evaluate what to expect during an inspection and how to best work with the FDA during the inspection
  • Describe key strategies for ensuring quality in clinical trials
  • Discuss approaches for responding to 483s and subsequent regulatory correspondence


Speakers
avatar for Miah Jung, Pharm.D., M.S.

Miah Jung, Pharm.D., M.S.

Acting Branch Chief, Compliance Enforcement Branch, Division of Enforcement and Postmarketing Safety, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, US FOOD AND DRUG ADMINISTRATION
Miah Jung is a lead pharmacologist in the Compliance Enforcement Branch (CEB), Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), FDA, and currently the acting Branch Chief in CEB. She has been with FDA for 9 years. In her work, she is responsible... Read More →


Tuesday September 28, 2021 11:30am - 12:15pm EDT

12:15pm EDT

Lunch
Tuesday September 28, 2021 12:15pm - 1:00pm EDT

1:00pm EDT

TRACK A: Critical To Quality Factors
Evaluate Risks to Ensure The Focus is Only On The Quality Issues That Matter
  • Understand the elements of the protocol that are critical and impact subject safety and/or data integrity
  • Evaluate the risks related to those identified critical processes and data
  • Identify risks on both the system and trial levels
  • Describe how to effectively document this identification process 

Speakers
avatar for Maria Weber

Maria Weber

Director, Risk Evaluation and Adaptive Integrated Monitoring, MERCK
avatar for Patrice Benner

Patrice Benner

Director, Risk Evaluation and Adaptive Monitoring (REAIM), MERCK
Over 20 years of Project Management, Data Management, and Clinical Trial Operations experience within pharma across multiple therapeutic areas including Vaccines, Infectious Disease and Neuroscience.  Passionate about patient safety, quality and risk evaluation, spending the last... Read More →


Tuesday September 28, 2021 1:00pm - 1:30pm EDT

1:00pm EDT

TRACK B: Clinical Trial Analytics
Identify Tools and Techniques to Reduce Risk, Monitor Progress and Increase Efficiency 
  • Identify risk factors to expose and manage with analytics
  • Define data to drive desired metrics
  • Understand general vs. trial-specific analytics
  • Evaluate individual, team and enterprise performance to increase efficiency

Speakers
avatar for Kathie Clark

Kathie Clark

Product Director, CTMS & eTMF, ENNOV
Kathie is Director, eTMF and CTMS for Ennov. She provides thought leadership for the industry and is the author of many white papers, journal articles and blog posts on eTMF, eClinical and regulatory topics. She is a member of the TMF Reference Model steering committee and has chaired... Read More →


Tuesday September 28, 2021 1:00pm - 1:30pm EDT

1:30pm EDT

TRACK A: eTMF and eISF Integration
Leverage an Integrated Approach Utilizing eTMF and eISF Purpose-Built Clinical Software to Improve Inspection Readiness
  • Discuss the benefits of a best in breed approach to delivering inspection readiness for site success
  • Understand each stakeholders’ responsibility for compliance so that internal resources are better able to manage patients
  • Case study examples of how this collaborative approach delivers compliance and inspection readiness

Speakers
avatar for Rick Arlow

Rick Arlow

CEO, COMPLION
Drawing on his engineering background and inspired by his work in clinical research through an NIH-funded MD/PhD medical scientist training program, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s... Read More →
avatar for Aaron Grant

Aaron Grant

Vice President, Solutions Consulting, PHLEXGLOBAL
Aaron Grant has been innovating in life science software for over 13 years. He is passionate about delivering practical, usable solutions that delight users and improve business practices. A technologist at heart, Aaron currently is heading Solutions Consulting at Phlexglobal helping... Read More →


Tuesday September 28, 2021 1:30pm - 2:00pm EDT

1:30pm EDT

TRACK B: Monitoring in a Decentralized World
How Digital Risk-Based Tools are Driving More Effective Study Oversight
  • Develop risk-based monitoring strategies which identifies critical to quality (CtQ) factors such as necessary data and processes
  • Understand the new data oversight strategies required for Decentralized Clinical Trials (DCTs) to detect and prevent issues earlier
  • Learn how to adopt a monitoring strategy that best aligns with the risks of a particular study

Speakers
avatar for Brian Barnes

Brian Barnes

Senior Director, Product Management, MEDIDATA
Brian Barnes is Senior Director, Product Development – RBQM for Medidata Solutions. Brian has 15 years in the clinical development space and specifically supported RBQM for the past 9 years specializing in operational solutions for small to large pharma, biopharma, and biotech companies... Read More →


Tuesday September 28, 2021 1:30pm - 2:00pm EDT

2:00pm EDT

Q&A With Previous Speakers
Tuesday September 28, 2021 2:00pm - 2:15pm EDT

2:15pm EDT

Networking and Refreshment Break
Tuesday September 28, 2021 2:15pm - 2:45pm EDT

2:45pm EDT

TRACK A PANEL: Remote QA Best Practices
Discuss Best Practices Learned During the Pandemic On Managing Clinical Quality Remotely   
  • Outline experiences with remote inspections and how this was executed from a technology standpoint
  • Identify challenges with remote site audits and remote study-level audits
  • Share thoughts on which QA practices may stay remote, even after the pandemic

Speakers
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 MyLe Hoang

MyLe Hoang

Senior Director, Clinical Quality Assurance, EISAI
MyLe Hoang has 22 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 senior... Read More →
avatar for Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste M. 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 →
avatar for Lauren Hartman, RQAP-GCP

Lauren Hartman, RQAP-GCP

Director, Clinical Quality Assurance, FIBROGEN
A well-rounded, effective, personable and team-oriented quality assurance professional with 18 years of clinical research and development experience, having overseen the conduct of complex, global clinical trials in accordance with national regulations and GCP guidelines and performed... Read More →


Tuesday September 28, 2021 2:45pm - 3:45pm EDT

3:45pm EDT

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. GLOBAL REGULATORY INSPECTIONS:  Navigate the Global Regulatory Challenges and Changing Landscape for Inspections 
  2. eTMF As An Oversight Tool: Leverage the eTMF as Evidence of GCP Compliance Across Partners
  3. MONITORING POST R2: Discuss Risk-Based Strategies for Monitoring and Trial Management
  4. VENDOR OVERSIGHT PLAN:  Identify the Critical Components of an Effective Vendor Oversight Plan
  5. NEXT GENERATION GCP AUDITING:  Leverage Internal, Site and Vendor Audits to Proactively Manage Risk
  6. ELIMINATE PROTOCOL DEVIATIONS: Discuss Proactive Strategies to Minimize/Eliminate Protocol Deviations and Effective Implementation Approaches

Tuesday September 28, 2021 3:45pm - 4:30pm EDT

4:30pm EDT

BOOZE AND SCHMOOZE NETWORKING RECEPTION
Remember face-to-face networking?  Let's do it again with a drink in hand!

Tuesday September 28, 2021 4:30pm - 5:30pm EDT
 
Wednesday, September 29
 

8:30am EDT

Registration and Networking
Wednesday September 29, 2021 8:30am - 9:00am EDT

9:00am EDT

TRACK A: Case Study of 100% Virtual COVID-19 Vaccine Trial
Journey Through the Development, Design and Execution of a Completely Remote COVID-19 Vaccine Trial 
  • Discuss the biggest challenges to clinical quality due to the necessary remote nature and how they were overcome
  • Evaluate clinical data flow and how integrity was documented
  • Detail the QA audits and GCP compliance oversight that was provided
  • Compare the execution of remote site and vendor audits and to pre-COVID norms

Speakers
avatar for Maryann Livolsi

Maryann Livolsi

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 September 29, 2021 9:00am - 9:30am EDT

9:00am EDT

TRACK B: Risk Remediation Strategies for Regulatory Inspections
Discuss Effective Risk Remediation Strategies Following an Inspection Finding
  • Walk through post-inspection actions when findings have been identified
  • Examine internal processes and systems to develop effective remediation approaches
  • Outline real life case studies to demonstrate how digitalization, migration and completeness are leveraged as keys to unlocking the TMF remediation process

Speakers
avatar for Aaron Grant

Aaron Grant

Vice President, Solutions Consulting, PHLEXGLOBAL
Aaron Grant has been innovating in life science software for over 13 years. He is passionate about delivering practical, usable solutions that delight users and improve business practices. A technologist at heart, Aaron currently is heading Solutions Consulting at Phlexglobal helping... Read More →
avatar for Sarah Tucker

Sarah Tucker

Senior Vice President, Customer Management, PHLEXGLOBAL
Sarah has 20 years’ experience working with Trial Master Files having started her career at Pfizer and moved from the Sponsor side of TMFs to Phlexglobal in 2007 to grow out TMF services. Sarah now resides in Pennsylvania, USA and is the SVP Customer Management for Phlexglobal ensuring... Read More →


Wednesday September 29, 2021 9:00am - 9:30am EDT

9:30am EDT

TRACK A: RBQM and Centralized Monitoring - Pfizer's COVID-19 Vaccine Development
How the use of RBQM and Centralized Monitoring Enabled Pfizer's Lightspeed Covid-19 Vaccine Development
  • Understand how and why RBQM principles and centralized monitoring were applied to the Pfizer Covid-19 vaccine program
  • Review key take-aways to inform RBQM centralized monitoring best practices moving forward

Speakers
avatar for Lynne Cesario

Lynne Cesario

Senior Director, Global Risk-Based Monitoring Program Lead, PFIZER
Lynne Cesario has more than 24 years of experience in clinical research and drug development in the pharmaceutical industry. She is currently a Senior Director in the Data Monitoring and Management department, leading the Global Risk Based Monitoring Program at Pfizer. As the overall... Read More →
avatar for Steve Young

Steve Young

Chief Scientific Officer, CLUEPOINTS
As CSO, Steve oversees the research and development of advanced methods for the CluePoints platform, along with providing RBQM methodology guidance to customers.  Steve worked in clinical data management over a span of 15 years, and has since focused on leading the development of... Read More →


Wednesday September 29, 2021 9:30am - 10:00am EDT

9:30am EDT

TRACK B: RBQM and TMF
Explore the Application of Risk-Based Quality Management to the Trial Master File (TMF)
  • Review of the core principles of RBQM
  • Discuss a risk-based approach to TMFs
  • Showcase real examples of risk-based approaches and interpretation of results
  • Share recommendations for the future 

Speakers
avatar for Lisa D. Mulcahy

Lisa D. Mulcahy

TMF Management, AUTOLUS THERAPEUTICS
Lisa Mulcahy has an extensive career in the pharmaceutical industry in the areas of Clinical Operations, Quality Management, and Clinical Documentation Management. For the past 14 years, she has focused on developing and operationalizing high-quality and compliant management processes... Read More →
avatar for Darshan Patel

Darshan Patel

Customer Success Leader, IQVIA TECHNOLOGIES
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 →


Wednesday September 29, 2021 9:30am - 10:00am EDT

10:00am EDT

Q&A With Previous Speakers
Wednesday September 29, 2021 10:00am - 10:15am EDT

10:15am EDT

Networking and Refreshment Break
Wednesday September 29, 2021 10:15am - 10:45am EDT

10:45am EDT

TRACK A PANEL: Documenting Oversight
Understand What Documentation Is Needed to Showcase Oversight to Inspectors 
  • Update on regulatory requirements for documenting oversight
  • Evaluate different company’s processes for documenting oversight of vendors and sites
  • Discuss experiences with regulators requesting or questioning oversight documentation
  • Recommend best practices for documenting oversight

Speakers
avatar for Eileen DiRita

Eileen DiRita

Associate Director, Quality Systems, CSL BEHRING
avatar for Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste M. 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 →
avatar for Dawn Lundin

Dawn Lundin

Clinical Research Compliance Director, UNIVERSITY OF PENNSYLVANIA PERELMAN SCHOOL OF MEDICINE
Dawn Lundin has over 24 years of GxP experience from quality assurance and compliance roles in both industry and academia. Versed in the Common Rule and clinical development regulations, currently head of compliance for the Perelman School of Medicine and Director of the Quality Assurance... 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 September 29, 2021 10:45am - 11:45am EDT

11:45am EDT

Lunch
Wednesday September 29, 2021 11:45am - 12:45pm EDT

12:45pm EDT

QUALITY MANAGEMENT SYSTEM
Strengthen your Culture of Quality with a Well-Developed Quality Management System (QMS) 
  • Discuss the correlation between a well-designed QMS and organizational culture 
  • Understand why implementing a QMS program is critical for growing organizations 
  • Optimize oversight and minimize compliance issues with an effective QMS
  • Leverage an effective QMS to streamline R&D process and culture integration from mergers and acquisitions 
  • Analyze organizational needs to implement a scalable QMS, one size does not fit all

Speakers
avatar for Anthea Dransfield, BSc, MSc, CChem, MRSC

Anthea Dransfield, BSc, MSc, CChem, MRSC

Managing Director, Quality Center of Excellence, ADVARRA CONSULTING
With over 25 years’ experience within analytical and manufacturing aspects of cGMP, operational leadership of clinical sites, and quality oversight spanning GxP, Anthea Dransfield brings a practical approach to Quality.  She advocates the need for structured, phase appropriate... Read More →
avatar for Dr. Steffen Engel

Dr. Steffen Engel

Managing Expert, Quality Center of Excellence, ADVARRA CONSULTING
Dr. Steffen Engel has served the pharmaceutical industry in various leadership roles with more than 20 years of professional international experience. His applied knowledge is focused on quality compliance and process optimization for strengthening and improving... Read More →


Wednesday September 29, 2021 12:45pm - 1:15pm EDT

1:15pm EDT

TRAINING THE NEXT GENERATION OF QUALITY PROFESSIONALS
Develop a Training and Auditing Program to Ensure our Quality Professionals Can Identify Quality Issues That Matter
  • Understand why traditional sampling and audit approaches may no longer work
  • 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 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 →


Wednesday September 29, 2021 1:15pm - 1:45pm EDT

1:45pm EDT

PANEL: 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 Maryann Livolsi

Maryann Livolsi

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 →
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 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 Donna Dorozinsky

Donna Dorozinsky

President and CEO, JUST IN TIME GCP
As the President & CEO of Just inTime GCP, Donna is responsible for running all facets of the business.   She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply... Read More →


Wednesday September 29, 2021 1:45pm - 2:45pm EDT

2:45pm EDT

CHAIRPERSON'S CLOSING REMARKS
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 →


Wednesday September 29, 2021 2:45pm - 3:00pm EDT
 
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