Clinical Trials Inspection Readiness Summit

Registration and Continental Breakfast For Workshop Participants

PRE-CONFERENCE WORKSHOP
Avoid FDA 483: Learn to Identify the Most Common Deficiencies at Clinical Sites and the Steps to Prevent Them

CHAIRPERSON’S WELCOME & OPENING REMARKS

Christine E. Buben, MS, MBA, Director, Clinical Operations,
TARSA THERAPEUTICS, INC.

Proactive Strategies to Ensure Continuous Compliance during Pre-Approval

Mark E. Lloyd, Program Section Leader, Primary Care Development Franchise, NOVARTIS PHARMACEUTICALS CORPORATION

Wayne Sadowski, Clinical QA Compliance Head, NOVARTIS PHARMACEUTICALS CORPORATION

Proactive Strategies to Avoid Protocol Non-Adherence

• Analysis of Site and Sponsor Drivers Of Protocol Non-Adherence 
• Practical Study Tools to Mitigate Protocol Non-Adherence and Enhance Site Quality
• Operational Risk Management Tactics to Complement Study Strategie 

Christine E. Buben, MS, MBA, Director, Clinical Operations,
TARSA THERAPEUTICS, INC.

Conducting Mock Inspections: Key Elements to Include for Training Improvement

• Establishment of Clear Roles and Responsibilities for All Functions Involved
• Advance Training of Individuals Who Will Be Involved to Set Proper Expectations
• Preparation of Individuals Who Will be Interviewed
• Structure of Audit and Preparation Rooms for Maximum Efficiency
  

Joseph Pollarine, Head of Compliance, Neuroscience Therapeutic Area,
JANSSEN R&D

Utilize Internal Audits as a Proactive Risk Management Strategy to Prepare for Inspections

• Manage and Implement an Effective Internal Audit System that Properly Prepares for Inspection
• Determine What to Look for Throughout an Audit and How Important Each Piece is
• Steps to Enhancing the Overall Success of Your Sponsor Audit

Peggy J. Berry, MBA, RAC, Vice President, Head of Quality & Regulatory Affairs, AMARIN CORPORATION

INTERACTIVE ROUNDTABLE DISCUSSIONS
Choose your preferred topic and discuss in an intimate, break-out style setting:

1. Inspection Readiness Europe: Discuss the protocol for a site inspection & GCP compliance in Europe
   Led by: Val Mikhailovski, Associate Director, Global Clinical Quality & Compliance, NOVARTIS VACCINES & COMPLIANCE
   
   
2. Inspection Readiness Asia: Discuss the protocol for a site inspection & GCP compliance in Asia
   Led by: Sunil Kotecha, Corporate Audit, PFIZER
   
   
3. Inspection Readiness Latin America: Discuss the protocol for a site inspection & GCP compliance in Latin America
   Led by: Clara Cordoba, Senior Manager, CQA Auditing, NOVARTIS
   
   
4. Investigator Responsibility: Define the various responsibilities of clinical investigators that tie into regulatory compliance at the site
   Led by: Leigh Gray, Clinical Research, Coordinator, NEURORADIOLOGY RESEARCH
   
   
5. Open Table: Discuss general challenges that emerge in any part of your inspection process

Chairperson’s Recap of Day One

Christine E. Buben, MS, MBA, Director, Clinical Operations,
TARSA THERAPEUTICS, INC.

Participating In a Site Inspection: Manage an Inspection and Overcome Challenges as They Occur

• Learn the Proper Steps to Follow During an Inspection
• Work with the Inspectors as they Approach Each Step in Their Inspection
  
• Determine Ways to Contain and Overcome Challenges as They Occur During the Inspection

Sina Djali, Director, Quality Monitoring & Compliance,
JANSSEN R&D

Allocate the Right Resources During an Inspection to Ensure Continuous Process Improvement with Duplicate Inspections

• How to manage multiple inspections taken place at the same time from various agencies
  
• Ensuring trial process improvement remains continuous during these multiple inspections
  
• Understanding priorities during each inspection

Karen J. Footit, MSM, MT (ASCP), Sr. Clinical Quality Systems Manager,
BOSTON SCIENTIFIC CORPORATION

Oversee the Quality of the Trial Master File in Inspection Readiness Preparation

• Conducting the TMF/Document QC
  
• Ensure file management, structure, and storage are ready from the start
  
• Provide the proper TMF plan and training to ensure compliance and inspection readiness
  

Val Mikhailovski, Associate Director, Global Clinical Quality & Compliance, NOVARTIS VACCINES & COMPLIANCE

Collaborative Communication to Support Enhanced Clinical Trial Oversight During Inspections: A Case Study from the Site and Sponsor Perspective

• Review best practices to ensure optimal clinical trial oversight and performance  
• Setting working standards that support long-term, collaborative relationships between sites and sponsors
  
• Steps to ensure communication is a two-way process in support of successful study execution
  
• Setting contingency plans to overcome inevitable challenges during study conduct

Joseph Popowicz, Director, Clinical Operations,
STRYKER

Alison Kilka, Research Program Manager,
CLEVELAND CLINIC

Engaging with CROs: Best Practices in the Selection and Oversight Processes to Ensure Inspection Compliance

• Understand the requirements needed from your CRO to fulfill and which CRO works best for you
  
• Ensure the site you choose is right for your organization and can meet your compliance needs
  
• Constantly engage with your site to ensure compliance throughout your trial
  

Sheila Wilson, MBA, Vice President, Clinical Operations
VERTEX PHARMACEUTICALS

Closing Panel Discussion: Discuss the Value of Post-Inspection Findings for Future Clinical Trial Inspections

Moderator:
Terrance J. Stevens, MS, Director, CQA,
ARRAY BIOPHARMA

Panelists:
Maryann Livolsi, MSN, RN, Director, R7D Compliance & Process,
SHIRE

Peggy J. Berry, MBA, RAC, Vice President, Head of Quality & Regulatory Affairs, AMARIN CORPORATION

Katie Alberta, Senior Director, Worldwide QA, Good Clinical and Pharmacovigilance Practices, CEPHALON, INC.

Leigh Gray, Clinical Research, Coordinator, Neuroradiology Research, MAYO CLINIC