Agenda – 9th Clinical Quality Oversight Forum

  • Pre-Conference Day
  • Main Conference Day One
  • Main Conference Day Two

Pre-Conference Day

 Wednesday October 16

 

MORNING WORKSHOP: QUALITY TOLERANCE LIMITS

8:30 – 12:00

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

Jonathan Rowe, Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER INC
Stacy St. John, Clinical Development Quality, GCP Quality Management Lead, PFIZER INC.

FULL-DAY SEMINAR: VENDOR RISK ASSESSMENT AND QUALIFICATION

 

 

AFTERNOON WORKSHOP: CLINICAL CAPAs

1:00 – 4:30

Effectively Respond to Noncompliance With the Proper Development and Execution of Corrective and Preventive Actions (CAPAs)

Sheila Gwizdak, M.S., Vice President, Quality, HALLORAN CONSULTING GROUP
Kathy Goldstein, Senior Director, Quality Management Lead, REGENERON PHARMACEUTICALS

FULL-DAY SEMINAR CONTINUES: VENDOR RISK ASSESSMENT AND QUALIFICATION

 


Main Conference Day One

 Thursday, October 17

9:00 – 9:30

CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE
Cheryl McCarthy, Director, Research Quality Assurance, IRONWOOD PHARMACEUTICALS

9:30 – 10:30

SENIOR LEADERS PANEL: A CULTURE OF QUALITY AND OVERSIGHT
Recognize Oversight As a Critical and Essential Part of a Quality Culture

Moderator:
Jane Wood, Quality Center of Excellence Lead, YOUR ENCORE; Former Vice President and Head, BioResearch and Quality Compliance, JOHNSON & JOHNSON

Panelists
Blake Jensen, Vice President, Quality and Compliance, G1 THERAPEUTICS, INC.
Jonathan Rowe, Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER
Christine Sahagian, Vice President, Head R&D Clinical Quality Assurance, TAKEDA

11:00 – 11:45

KEY FINDINGS FROM THE TUFTS CSDD-AVOCA VENDOR QUALIFICATION BENCHMARKING STUDY
Quantify Vendor Qualification Practices and Experiences and Identify Improvement Opportunities

Kenneth A. Getz, MBA, Director of Sponsored Programs, Associate Professor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
Dennis Salotti, Chief Operating Officer, THE AVOCA GROUP

12:30 – 1:30

Lunch

 

BEYOND RISK-BASED MONITORING (RBM)

1:30 – 2:15

Leverage Intelligent Analytics to Drive Higher Quality and Support ICH E6 R2 Compliance

Steve Young, Chief Operations Officer, CLUEPOINTS

OVERSIGHT OF DIFFERENT SUPPLIER TYPES

 

SITE-LEVEL RISK MANAGEMENT

2:15 – 3:00

Interpret Observations at the Site-Level and Develop Them Into Action Plans to Improve Operations and Mitigate Risk

Sheila Gwizdak, M.S., Vice President Quality, HALLORAN CONSULTING GROUP
Krista Tibbs, Specialist, Clinical Development, HALLORAN CONSULTING GROUP

TRIAL MASTER FILE (TMF)

2:15 – 3:00

Utilize the TMF As an Oversight Tool to Ensure Data Integrity and Maintain an Inspection-Ready State

Marion Mays, Vice President, Client Solutions and Quality Assurance, PHLEX GLOBAL

 

3:30 – 4:30

PANEL DISCUSSION: OVERSIGHT POST ICH E6 R2
Discover How Vendor and Site Oversight Practices Have Changed As a Result of ICH E6 R2

Moderator
Dawn M. Niccum, RN/MS, RQAP-GCP, CCRA, PMP, Senior Director, Quality Assurance and Compliance, INSEPTION GROUP

Panelists
Shelly Weeks-Townsend, M.S., CQA, Director, Quality Assurance, ZYNERBA PHARMACEUTICALS

Additional Panelists TBD

4:30 – 5:15

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 also have the opportunity to also sign up onsite.

  1. STORYBOARDS AS AN OVERSIGHT TOOL: Discuss How Storyboards Are Being Used to Document Oversight
  2. MOCK INSPECTIONS: Leverage Mock Inspections As an Oversight Tool
  3. GDPR COMPLIANCE: Evaluate the Impact of GDPR on Oversight and Clinical Operations
  4. DATA INTEGRITY: Examine What Practices and Tools Are Being Utilized to Ensure Data Integrity at the Site and Vendor Levels
  5. OUTSOURCED OVERSIGHT: Evaluate the Pros and Cons of Outsourced Oversight and How to Ensure It is Effective
  6. OVERSIGHT OF RISK MANAGEMENT: Discuss How to Oversee Effective Execution of Your Risk Management Plan
  7. KEY RISK INDICATORS (KRIs): Identify Key Risk Indicators That Are Being Used to Ensure Effective Oversight
  8. CRO OVERSIGHT PLAN: Evaluate the Critical Elements of an Effective CRO Oversight Plan
  9. VENDOR TRANSITION: Discuss Leading Practices for Handling and Documenting Vendor Transitions
  10. QUALITY MANAGEMENT SYSTEMS (QMS): Leverage Your QMS to Ensure Effective Oversight
  11. CRA ASSESSMENTS: Ensure Qualified and Competent Monitoring With a CRA Assessment Strategy
  12. TRAINING OPTIMIZATION: Optimize Both CRO and Site Training Initiatives to Decrease the Need for Oversight
  13. OVERSIGHT OF PREFERRED PROVIDERS: Assess Qualification and Oversight Strategies When Working Within the Preferred Provider Outsourcing Model
  14. QUALITY AGREEMENTS: Understand the Purpose and Value of Quality Agreements and Outlining the Essential Elements
  15. DATA LITERACY: Assess Your Data Literacy and How it Impacts the Effectiveness of Your Risk Management and Oversight Activities


Main Conference Day Two

 Friday, October 18

9:00 – 9:30

CHAIRPERSON’S OPEN AND KEY LEARNING POINTS FROM PREVIOUS DAY
Cheryl McCarthy, Director, Research Quality Assurance, IRONWOOD PHARMACEUTICALS

9:30 – 10:30

REGULATORY UPDATE: FDA INSPECTIONS
Evaluate Center for Drug Evaluation and Research (CDER) Bioresearch Monitoring (BIMO) Inspections of Clinical Investigators and Sponsors

Miah Jung, Pharm.D., M.S., Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA

11:00 – 11:45

RISK-BASED AUDITING STRATEGY
Develop and Implement a Risk-Based Auditing Approach to Proactively Assess Risk and Optimize Resources

Maryann Livolsi, MSN, RN, Senior Director, GCP Quality Assurance, BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE

12:30 – 1:30

Lunch

2:30 – 2:45

CHAIRPERSON’S CONCLUDING REMARKS
Cheryl McCarthy, Director, Research Quality Assurance, IRONWOOD PHARMACEUTICALS