Agenda – 9th Proactive GCP Compliance

  • Workshops
  • Day One
  • Day Two

Workshops

 Monday, March 19

10:00AM – 10:30AM

30-Minute Networking Break

10:30AM – 12:00PM

Workshop Resumes

1:00PM – 2:30PM

WORKSHOP B: ENSURING DATA INTEGRITY
Examining Effective Strategies for Ensuring Data Integrity When Executing Risk-Based Management Approaches

Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
Besty Fallen, Regulatory and Clinical Process Consultant, BAFALLEN CONSULTING, LLC

3:00PM – 4:30PM

Workshop Resumes


Day One

 Tuesday, March 20

8:45AM – 9:15AM

CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE
Joanne Spallone, Global Development Quality Audit Head, NOVARTIS

9:15AM – 10:15AM

SENIOR LEADERS PANEL: PROACTIVE RISK MANAGEMENT
Understanding How Senior Leaders are Developing a Culture of Quality to Drive a Proactive Risk Management Approach

Moderator
Laurie Halloran, President and CEO, HALLORAN CONSULTING GROUP

Panelists
Katie Alberta, Global Head, QA, GLP, GCP, GPvP and PDMA, ALKERMES
Fred Feldstein, Vice President, Global Head of BioResearch Quality and Compliance, JOHNSON & JOHNSON
Simon Trowell, Vice President, Quality and Risk Management, R&D Projects, Clinical Platforms and Sciences, GSK

10:15AM – 10:45AM

Networking Break

10:45AM – 11:30AM

PFIZER CASE STUDY: RISK MANAGEMENT MODERNIZATION
Examining the Evolution of Risk Management Post-ICH E6 R2 and Outlining the Critical Changes That Have Occurred

Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

12:15PM – 1:15PM

Lunch

2:00PM – 2:45PM

ACADIA CASE STUDY: SHIFTING TO PROACTIVE RISK MANAGEMENT
Examining a Small Company’s Transition From Reactive Issue Resolution to ICH E6 R2 Compliant Proactive Risk Management and a Continual State of Inspection Readiness

Maryann Livolsi, MSN, RN, RQAP-GCP, Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALS
Stefan van den Akker, M.Sc., Director, R&D Quality and Risk Management, ACADIA PHARMACEUTICALS

2:45PM – 3:15PM

Networking Break

3:15PM – 4:15PM

PANEL DISCUSSION: GLOBAL REGULATORY INSPECTIONS
Navigating the Global Regulatory Challenges and Changing Landscape for Inspections

Panelists
Nancy Bitters, Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONO
Mike Sobczyk, Senior Director, Regulatory Compliance, GILEAD SCIENCES
Steven Talerico, M.S., Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK

4:15PM – 5:15PM

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. RISK-BASED AUDITING: Developing Auditing Plans That Focus Efforts on High-Risk Areas
  2. QUALITY AGREEMENTS: Understanding the Purpose of a Quality Agreement and How It Differs From a Contract
  3. QUALITY MANAGEMENT PLANS: Outlining the Critical Factors of an Effective Quality Management Plan
  4. MEASURING RISK: Defining Critical Quality Factors and Metrics to Accurately Assess Risk
  5. RISK-BASED MONITORING: Implementing an Effective Risk-Based Monitoring Approach
  6. INSPECTION READINESS: Building Inspection Readiness As a Continual State, Not a Process
  7. ELECTRONIC INFORMED CONSENT FORMS (eICF): Understanding Expectations and the New Guidance Document Surrounding eICFs
  8. REMOTE MONITORING: Discussing Best Practices and Lessons Learned When Monitoring Remotely
  9. QUALITY MANAGEMENT SYSTEMS (QMS) AT SMALL COMPANIES: Implementing an Effective QMS When Working With Limited Resources at a Small Company
  10. OVERSIGHT OF SUB-CONTRACTORS AND THIRD PARTIES: Reviewing Requirements and Discussing Best Practices for Effectively Overseeing the Quality of Sub-Contractors and Third Parties


Day Two

 Wednesday, March 21

8:30AM – 8:45AM

CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAY
Joanne Spallone, Global Development Quality Audit Head, NOVARTIS

9:30AM – 10:30AM

PANEL DISCUSSION: RISK MANAGEMENT TOOLS
Evaluating Various Systems, Tools and Processes That Have Proven Effective for Proactively Measuring, Tracking and Managing Clinical Risk

Panelists
Richard Azueta, Head, GxP Audit, NOVARTIS
Cheri Wilczek, President, CLINAUDITS, LLC
Pamela Gustafson, Vice President, Clinical Research, PROTEON THERAPEUTICS, INC.

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

TRANSCELERATE’S FREE RISK ASSESSMENT CATEGORIZATION TOOL (RACT)
Leveraging RACT to Define, Categorize and Quantify Clinical Trial Risk

Karine Julien, Executive Director, Quality Assurance Therapeutic Area Head, Primary Care, MERCK

11:45AM – 12:45PM

PANEL DISCUSSION: TRAINING OPTIMIZATION
Evaluating Effective Strategies to Optimize GCP Training and Mitigate Risk of Non-Compliance

Panelists
Jennifer Clark, Director, Quality Systems, FERRING PHARMACEUTICALS, INC.
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
Shari Zeldin, B.S., CCRC, Clinical Research Compliance Officer, Department of Medicine, UNIVERSITY OF WISCONSIN

12:45PM – 1:45PM

Lunch

2:30PM – 3:30PM

PANEL DISCUSSION: ESCALATION PLANS AND CLINICAL CAPAs
Discussing Effective Procedures for Handling and Resolving Issues Once They’ve Been Identified

Panelists
Teresa DeVincentis, Senior Director, Clinical Quality Management, CELGENE
Dawn Lundin, Director, Quality Assurance, MERCK
Doreen McGirl, Director, Quality Assurance, CARDIOVASCULAR RESEARCH FOUNDATION

3:30PM – 3:45PM

CHAIRPERSON’S CONCLUDING REMARKS
Joanne Spallone, Global Development Quality Audit Head, NOVARTIS