7:45 Registration and Continental Breakfast for Morning Workshop Participants

8:30 WORKSHOP: MONITORING POST R2 (ICH E6 R2 5.18)

Outline and Execute a Risk-Based Approach for Monitoring and Trial Management Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN

› Understand the purpose of monitoring › Discuss the extent and nature of monitoring

» Achieve a systematic, prioritized, risk-based approach to monitoring that incorporates flexibility to improve effectiveness and efficiency »Document the rationale for the chosen monitoring strategy

› Evaluate types of monitoring » Describe when on-site monitoring, a combination of on-site and centralized monitoring or just centralized monitoring make sense » Examine examples of statistical analyses from centralized monitoring and the actions that resulted

› Dissect the monitoring plan » Tailor plan to specific human subject protection and data integrity risks of the trial »Describe monitoring strategy, responsibilities of all involved parties, methods, and rationale for use » Emphasis on monitoring of critical data and processes

› Manage monitoring reporting »Build a timely reporting schedule of onsite and/or centralized monitoring » Document all monitoring results to allow verification of compliance with monitoring plan and applicable regulations and standards

10:00 30-Minute Networking Break

12:00 Lunch for Morning Workshop Participants

12:30 Registration for Afternoon Workshop

1:00 WORKSHOP: QUALITY CULTURE IMPLEMENTATION

Shift to a Quality Culture and Manage the Change Effectively Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Senior Director, Quality Assurance and Compliance, INSEPTION GROUPKarin Rezzonico, Associate Director, Clinical Quality Compliance, INSEPTION GROUP

› Understand the importance of change management when it comes to initiating and sustaining a cultural shift

»Organizational » Systems » Initiatives/Processes

› Examine both the “process” and “human” sides of change and recommendations on how to address › Prepare for change by defining a clear outcome and identifying change leaders › Define what a quality culture means to your organization › Implement effective change management techniques to build that quality culture

»Move from a reactive to a proactive culture » Identify resistance and tactics to overcome

› Evaluate the result, addressing gaps and determining next steps for sustainability › Leave with a personalized strategy for shifting your company to a culture of quality

2:30 30-Minute Networking Break

4:30 Workshop Concludes

Monday, March 18, 2019 – Workshops

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Tuesday, March 19, 2019 – Main Conference Day One

8:00 Registration and Continental Breakfast

8:45 CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE April Rafkind, MS.c., Director, Pharma Clinical Quality Assurance, NOVARTIS

9:15 SENIOR LEADERS PANEL: QUALITY MANAGEMEENT POST R2Reflect on the Actions, Process Adjustments and Cultural Shifts That Have Resulted From ICH E6 R2ModeratorGreg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUPPanelistsDeb Driscoll, Vice President, Quality Assurance, MERCK RESEARCH LABS Dave Nickerson, Head of Clinical Quality Management, EMD SERONO ADDITIONAL PANELISTS TBD• Examining how operations were assessed to determine where adjustments needed to be made to ensure compliance• Developing action plans and aligning responsibilities• Identifying the challenges and obstacles and how they were overcome• Discussing lessons learned and what could have been done better

10:15 Networking Break

10:45 RISK IDENTIFICATION (ICH E6 R2 5.0.1 & 5.0.2)Identify Critical Processes and Data, and Their Associated Risks Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN• 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

11:30 RISK CONTROL AND COMMUNICATION (ICH E6 R2 5.0.4 & 5.0.5)Define Quality Tolerance Limits and Effectively Communicate These Parameters Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC • Establish quality tolerance limits that identify systematic issues that can impact subject safety or data integrity• Determine which risk to reduce and/or which to accept• Outline and incorporate risk reduction activities into necessary processes and plans• Document all risk parameters and risk management activities to all involved parties

12:15 Lunch

1:15 QUALITY BY DESIGNBuild Quality Into Clinical Trials to Proactively Identify and Mitigate Risk Sharon Reinhard, M.S., Executive Director, MRL Quality Assurance, MERCK Reetu Dandora, Executive Director, MRL Quality Assurance, MERCK • Understand the definition and purpose of quality by design• Assess how to apply a quality-by-design approach to clinical risk management• Outline proactive measures to perform in real time to avoid retrospective reactions following audits• Examine case studies of fundamental failures that would have been prevented with a quality-by-design approach

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2:00 CRO-VENDOR OVERSIGHT PLAN (ICH E6 R2 5.2.2)Define the Framework and Critical Elements of an Effective CRO-Vendor Oversight Plan Liz Wool, President, WOOL CONSULTING GROUP, INC.• Evaluate ICH E6 R2 and identify the requirements for sponsors and CROs related to CRO-vendor oversight• Examine an effective CRO-vendor management framework• Define the critical elements to a successful CRO-vendor oversight plan

2:45 Networking Break

3:15 PANEL DISCUSSION: CRO OVERSIGHT (ICH E6 R2 5.2.2) Ensure and Document Effective Oversight of CRO and Third Parties – Discuss Case Studies and Best PracticesModeratorJane Wood, Quality Center of Excellence Lead, YOUR ENCORE PanelistsJason Donnelly, Director, Clinical Quality and Compliance, SCHOLAR ROCK, LLCDan Walsh, Director, Clinical Oversight, MYLAN Michael Wieczerak, Associate Director, Clinical Quality Management, EMD SERONO• Share best practices for effective documentation of CRO oversight• Discuss lessons learned in oversight when uncovering issues at the CRO• Understand sponsor requirements when it comes to oversight of CRO’s subcontractors• Ensure subcontractors are qualified and monitored through effective oversight plans and documentation/

communication with CRO

4:15 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 have the opportunity to also sign up onsite.

1. QUALITY CONCERNS RELATED TO CLINICAL TRIAL CONDUCT: Handle Quality Issues Related to the Conduct ofClinical Trials Such As Serious Breach and Privacy Breach

2. CHINA INSPECTIONS: Share Experiences With Inspections in China and How to Prepare3. TRAINING OPTIMIZATION: Examine Different Training Methodologies and Discussing Their Effectiveness4. QUALITY BY DESIGN: Build Quality Into Trial Operations at the Onset to Ensure Quality Is the Priority and

Streamline Oversight 5. GDPR COMPLIANCE: Understand the Impact of GDPR in the Clinical Space and How to Achieve Compliance6. RISK MANAGEMENT TOOLS: Evaluate Various Systems, Tools and Processes That Have Proven Effective for

Proactively Measuring, Tracking and Managing Clinical Risk7. QUALITY METRICS: Identify Clinical Quality Metrics That Are Critical for Mitigating Risk8. RISK-BASED MONITORING: Strategize on Effective Execution of Risk-Based Monitoring and Lessons Learned

From Implementation9. OVERSIGHT OF SUBCONTRACTORS AND THIRD PARTIES: Review Requirements and Discuss Best Practices to

Effectively Oversee the Quality of Subcontractors and Third Parties10. QUALITY MANAGEMENT PLANS: Determine What Makes an Effective Quality Management Plan11. RISK-BASED AUDITING: Developing Auditing Plans That Focus Efforts on High-Risk Areas

5:15 Day One Concludes

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Wednesday, March 20, 2019 – Main Conference Day Two

7:45 Registration and Continental Breakfast

8:30 CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAYApril Rafkind, MS.c., Director, Pharma Clinical Quality Assurance, NOVARTIS

8:45 RISK REVIEW AND REPORTING (ICH E6 R2 5.0.6 & 5.0.7)Conduct Continual Review of Risk Control Measures for Needed Adjustments and Effectively Report Any ChangesSteven Whittaker, Senior Consultant, THE AVOCA GROUP• Recognize that effective risk management requires continual review• Review and mitigate anticipated risks by taking actions that may prevent reaching control limits• Conduct continual review of risk control measures for needed adjustments and effectively report any changes

-Take into account emerging knowledge and experience to adjust quality tolerance limits and risk control measuresto ensure they remain effective and relevant

• Document any deviations from original quality tolerance limits to explain implications and/or justify the subsequentadjustments

9:30 PANEL DISCUSSION: GLOBAL INSPECTION READINESS Discuss Global Challenges to Achieve a Constant State of Inspection Readiness PanelistsNancy Bitters, Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONOSheila Gwizdak, Principal Consultant, HALLORAN CONSULTING GROUPCheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN• Discuss which regulatory agencies are posing the most challenges and why

- Understand how to best handle inspections from China FDA • Identify the impact of ICH E6 R2 on inspection readiness processes• Evaluate any anticipated global regulatory changes that may impact inspections

10:30 Networking Break

11:00 PI PERSPECTIVE: QUALITY AT THE SITE-LEVEL (ICH E6 R2 4.2.5 & 4.2.6)Understand Quality Expectations From the Perspective of the Principal Investigator (PI) and How That Compares to the Sponsor Jeff Kingsley, CEO, IACT HEALTH• Identify how the PI is responsible for ensuring quality of trial-related duties and functions conducted at the site• Discuss quality and oversight expectations of the sponsor and how they may not be aligned with the PI• Understand how sponsors and investigators can collaborate effectively to ensure quality and data integrity

11:45 RISK ASSESSMENT OF DATA SYSTEMS VALIDATION (ICH E6 R2 5.5.3)Conduct Risk Assessments for Validation of Electronic Trial Data Handing and/or Remote Electronic Trial Data Systems• Understand to what trial management, data handling, and record keeping systems this applies• Outline a risk assessment to determine which systems must be validated• Examine necessary processes and documentation to show the system conforms to the sponsor’s established

requirements for completeness, accuracy, reliability and consistent intended performance• Determine that systems are secure and designed to permit and document all data changes• Ensure the integrity of the data through any changes to the systems such as upgrades or data migration

12:30 Lunch

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Wednesday, March 20, 2019 – Main Conference Day Two continued

1:30 ESSENTIAL DOCUMENTATION (ICH E6 R2 8.1)Identify the Essential Trial Documentation and How It Should Be MaintainedMichele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY • Discuss Trial Master File and Investigator Site File and what data should be included• Understand what will be required during an inspection related to essential documentation• Determine how long these documents need to be maintained following database lock• Manage legacy systems and system integration• Evaluate the use of certified copies and what is acceptable

2:15 PANEL DISCUSSION: NONCOMPLIANCE (ICH E6 R2 5.20)Address Identified Noncompliance Through Root Cause Analysis and CAPAModerator April Rafkind, M.Sc., Director, Pharma Clinical Quality Assurance, NOVARTIS PanelistsJolie Weintraub, Executive Director, MRL Quality Assurance, Therapetuic Area Head-Oncology, MERCK Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY ADDITIONAL PANELISTS TBD • Discuss case study examples of noncompliance and how it was identified• Determine if the noncompliance should result in a root cause analysis and CAPA• Share noncompliance identified through monitoring or auditing that was serious and/or persistent and resulted in

termination of the site• Outline best practices and lessons learned for handling noncompliance from the panelists’ experience

3:15 CHAIRPERSON’S CONCLUDING REMARKSApril Rafkind, MS.c., Director, Pharma Clinical Quality Assurance, NOVARTIS

3:30 Close of Conference

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