REGISTRATION AND CONTINENTAL BREAKFAST CHAIRPERSON’S OPENING REMARKS Katherine Taylor, Director, GCP Inspection Management, MERCK RECOGNIZE TOOLS TO FOSTER A CULTURE OF COLLABORATION AND INHERENT INSPECTION READINESS ò Discuss the core components of inspection readiness and how they can be built into everyday processes ò Understand the importance of your people; how prepared are they to address challenges that come up during inspections? ò Explain the necessity of interdepartmental collaboration to ensure internal preparedness ò Communicate the commitment required for change management to be a company-wide initiative that mitigates inspection risk Lydia Milne, Director, Quality Systems Inspection Program, ASTELLAS LESSONS LEARNED: LEVERAGING RESOURCES FOR SMALL TO MID-SIZE SPONSORS Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY NETWORKING BREAK INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO OPTIMIZE INSPECTION PREPARATION ò Refine processes that enable internal stakeholders to increase efficiency throughout the entire study, not just during the inspection preparation period ò Understand nuances of inspection preparation deliverables according to agency expectations ò Discuss the tools made available through technology to ascertain an accurate status of inspection readiness and facilitate inspection preparation ò Train and support the education of functional departments to ensure internal synergy ò Build credulity within your Inspection preparation team Katherine Taylor, Director, GCP Inspection Management, MERCK MOCK INSPECTIONS: A CRITICAL TOOL TO ENSURE INSPECTION READINESS ò Discuss the benefits of an ongoing state of inspection readiness throughout a trial ò Define proactive approaches for clinical operations and quality to work together to maintain inspection readiness ò Introduce mock inspection as a periodic “check-up” for overall Inspection Health ò Identify where hidden challenges may lurk and how to address them ò Formulate system/organization-level remediation plans rather than study-specific “band-aids” Kristen Bennett, Associate Director, Client Delivery, THE AVOCA GROUP Grace Crawford, VP, Clinical Quality and Compliance, ASTRAZENECA LUNCHEON BUILD EFFECTIVE TRAINING PROGRAMS FOR THE BIOPHARMA INDUSTRY ò Define governance model for effective training program ò Establish tools/LMS needed to manage the training program ò Explore the competency model and risk-based delivery model ò Examine various ways to measure training effectiveness Sharon Brower, Director Training and Process and Continuous Improvements, BRISTOL-MYERS SQUIBB 8:00 9:00 9:15 10:00 11:30 11:00 CONFERENCE DAY ONE | MONDAY, AUGUST 14 12:15 1:00 2:00 LESSONS LEARNED www.asdevents.com - www.asdevents.com/event.asp?id=20430
RECOGNIZE TOOLS TO FOSTER A CULTURE OF COLLABORATION AND INHERENT INSPECTION READINESS
ò Discuss the core components of inspection readiness and how they can be built into everyday processes ò Understand the importance of your people; how prepared are they to address challenges that come up during inspections?
ò Explain the necessity of interdepartmental collaboration to ensure internal preparedness ò Communicate the commitment required for change management to be a company-wide initiative that mitigates inspection risk
Lydia Milne, Director, Quality Systems Inspection Program, ASTELLAS
LESSONS LEARNED: LEVERAGING RESOURCES FOR SMALL TO MID-SIZE SPONSORS
INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO OPTIMIZE INSPECTION PREPARATION
ò Refine processes that enable internal stakeholders to increase efficiency throughout the entire study, not just during the inspection preparation period
ò Understand nuances of inspection preparation deliverables according to agency expectations ò Discuss the tools made available through technology to ascertain an accurate status of inspection readiness and facilitate inspection preparation
ò Train and support the education of functional departments to ensure internal synergy ò Build credulity within your Inspection preparation team
MOCK INSPECTIONS: A CRITICAL TOOL TO ENSURE INSPECTION READINESS ò Discuss the benefits of an ongoing state of inspection readiness throughout a trial ò Define proactive approaches for clinical operations and quality to work together to maintain inspection readiness ò Introduce mock inspection as a periodic “check-up” for overall Inspection Health ò Identify where hidden challenges may lurk and how to address them ò Formulate system/organization-level remediation plans rather than study-specific “band-aids”
Kristen Bennett, Associate Director, Client Delivery, THE AVOCA GROUPGrace Crawford, VP, Clinical Quality and Compliance, ASTRAZENECA
LUNCHEON
BUILD EFFECTIVE TRAINING PROGRAMS FOR THE BIOPHARMA INDUSTRY ò Define governance model for effective training program ò Establish tools/LMS needed to manage the training program ò Explore the competency model and risk-based delivery model ò Examine various ways to measure training effectiveness
Sharon Brower, Director Training and Process and Continuous Improvements, BRISTOL-MYERS SQUIBB
LESSONS LEARNED: BREAKING DOWN SILOS WITH CLINICAL OPS, TMF OPS, AND CLINICAL QUALITY — CREATING AN INSPECTION READINESS OVERSIGHT MODEL
ò Create CRO oversight review process and determine how to use eTMF systems to document oversight for inspection readiness throughout the trial
ò Show how a global cross-functional team can break down silos and increase transparency to move towards consistency across therapeutic areas and Phases
ò Work with CRO partners for input and implementation of oversight model ò Develop a change management plan for successful implementation
Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYOLaura Naranjo, Manager, TMF Operations, Clinical Development Operations, DAIICHI SANKYO
NETWORKING BREAK
SUCCESSFUL PARTNERSHIPS AND COLLABORATION WITH CROS, SPONSORS, SITES, AND VENDORS
ò Explore early expectation setting and quality agreements ò Understand the importance of collaborative and comprehensive RACI and study plans ò Analyze performance and risk indicators as well as metrics tracking ò Discuss governance meetings and their importance
Julia Moore, Associate Director, SANGAMO THERAPEUTICS
PANEL DISCUSSION: GLOBAL INSPECTION READINESS: HOW IT TRANSLATES INTO REAL-LIFE INSPECTION SUCCESS OR FAILURE
ò Discuss which regulatory agencies are posing the most challenges and why ò Identify the impact of ICH E6 R2 ò Gain industry perspective on inspection readiness and best practices ò Analyze the impact of Brexit ò Evaluate any upcoming regulations that will impact GCP ò Explore the regulatory framework of EU and ICH
CAPTURE INSPECTION READINESS THROUGH VENDOR OVERSIGHT STRATEGIES ò Discuss strategies, best practices, and general thinking principles to follow ò Ensure roles, responsibilities, and escalation pathways are clearly defined to make handoffs smoother ò Avoid dependency on vendors by using risk-based approaches to best oversee the vendor you select
Vinita Leslie, Head of Clinical Quality, Oncology, TAKEDA
PANEL DISCUSSION: INSPECTION READINESS THROUGHOUT THE LIFE CYCLE: HOW TO STAY INSPECTION-READY
ò Discuss the documentation, processes, and systems required to maintain inspection readiness throughout an entire clinical trial
ò Analyze the importance of TMF and the expectations as an active repository ò Clarify the roles and responsibilities of operational staff members ò Pinpoint the best practices for interfacing with vendors for readiness as well as actual inspections ò Compare and contrast the approaches for inspection readiness to prepare for different health organizations
Michael Wieczerzak, Associate Director, Clinical Quality Management, EMD SERONO Laura Naranjo, Manager, TMF Operations, Clinical Development Operations, DAIICHI SANKYO If you are interested in joining this panel, contact Brianna Conetta at [email protected] or 212-400-6234.
NETWORKING BREAK
NAVIGATE THE SPONSOR AND SITE RELATIONSHIP THROUGHOUT AN INSPECTION
Alyssa Gateman, Director, QA, YALE SCHOOL OF MEDICINELinda Coleman, Director, Human Research Protection Program, YALE SCHOOL OF MEDICINE
DISCUSS BEST PRACTICES FOR PREPARING, HOSTING, AND RESPONDING TO REGULATORY INSPECTIONS IN ACADEMIA
ò Execute thorough preparation to enable a strong foundation for any inspection ò Understand the culture of preparedness during an inspection and outline what to do and what not to do ò Respond to Form FDA 483 to ensure there are solutions (CAPA) following an inspection
Johanna Stamates, Executive Director, Research Compliance and Quality Assurance, UNIVERSITY OF MIAMI MEDICAL CENTER
PANEL DISCUSSION: MEETING THE CHALLENGES: WHAT CAN WE LEARN FROM OTHER COUNTRIES?
ò Gather current inspection trends and look at how companies embed inspection readiness into their culture ò Discuss the best practices for inspection readiness ò Identify how companies are training their staff to be inspection-ready at all times ò Describe some of the inspection outcomes after ICH E6 R2 as well as the challenges and lessons learned
If you are interested in joining this panel, contact Brianna Conetta at [email protected] or 212-400-6234.
MOCK INSPECTIONS: UNDERSTAND THE JOURNEY OF PREPARATION ò Understand the need to be inspection-ready at any moment ò Discuss the importance of carrying out a mock inspection and what the results could mean ò Define strategies for planning a mock inspection ò Analyze the requirements your organization should fulfill leading up to a mock inspection ò Practice adapting to questions and real-life inspection scenarios in action and prepare for FDA investigators
