CLINICAL TRIALS INSPECTION READINESS SUMMIT. Trial Master Files. Inspection Trends. Metrics Analysis. Partner Oversight

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1 5th CLINICAL TRIALS INSPECTION READINESS Ensure Inspection Readiness Through Improved Early Preparation Standards, Organized Documentation and Continuous Vigilance from All Stakeholders August 8-9, 2016 Sonesta Hotel Philadelphia Philadelphia, PA SUMMIT Led by Our Expert Speaking Faculty: Conference Chairperson Amer Alghabban Vice President GxP Quality Assurance, Compliance Training KARYOPHARM THERAPEUTICS Trial Master Files Inspection Trends Jamie Toth Head of TMF Operations DAIICHI SANKYO Joyce Feldman Director QA, Inspection, Risk Management Pharma Development NOVARTIS Nancy Bitters GCP Inspection Manager PFIZER TOP FIVE REASONS TO ATTEND: 1. Implement inspection readiness strategies to further the effectiveness of your company s system Metrics Analysis Regulatory Compliance INSPECTION READINESS Pharmacovigilance Partner Oversight 2. Review crucial information and analyze regulations from around the world, with a focus on FDA policies 3. Discuss the application of electronic files to your TMF, and how this will affect inspections 4. Analyze strategies to help organize all files in a streamlined and comprehensive clinical trial storyboard for inspectors 5. Benchmark the success of your clinical trial through metrics analysis and enhance partnerships with all stakeholders to increase efficiency NEW SESSIONS INCLUDE: Panel Discussion: Effective Site Selection and Optimization Procedures An Analysis of Past and Present Inspection Trends in Preparation for the Future Panel Discussion: Compliance Considerations for International Regulatory Inspections Begin and Maintain a Continuously Inspection-Ready TMF The Necessity of Outsourcing Effectively in Order to Make Valuable Partnerships

2 WHO SHOULD ATTEND? This conference is designed for representatives from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas: Quality Assurance/Quality Control/Quality Compliance/Quality Management Clinical Operations Dear Colleague, Over the past few years, there has been a significant rise in the number of inspections conducted. With this increase in frequency comes stricter guidelines and higher standards from regulatory bodies. Since all inspections are different, a sponsor organization needs to be prepared for any curveballs thrown at them, regardless of the regulatory authority conducting the inspection. Preparing a robust clinical trial inspection readiness plan involves many moving parts. Included in this plan is the oversight of every partner involved in the study, which can range from a CRO to all of the different clinical sites where the trial is taking place. Proper training and management of all stakeholders is a necessary component of the preparation process. Millions of dollars are spent on the development of effective strategies to plan and execute inspections, yet many issues can still arise. Failing an inspection can lead to severe consequences and potentially result in the shutdown of a clinical trial. Between the industry s rapid evolution and the push to integrate technology into all aspects of business, it is crucial your organization stays up to speed and educated on the latest trends. The shift to etmf and eisf systems is inevitable, and the way inspectors will conduct trials in the near future is sure to follow suit. The 5th Clinical Trials Inspection Readiness Summit is the place where pharmaceutical professionals can come together to discuss developments that affect the industry as a whole. Over the course of two days, this event will provide sponsors, CROs, sites and technology vendors with best practices to ensure they remain prepared. Join us in August in Philadelphia, and take home the knowledge that will help your organization be inspection ready. Records/Data/Document Management Clinical Trials Management Global Compliance Clinical Monitoring Clinical Research Safety and Risk Management/Operations Auditing Clinical Project Management Trial Master Files Clinical Development Clinical Document Coordination Clinical Site Management Global Regulatory Affairs Adverse Events Investigator Site Files This program is also of interest to clinical QA and compliance professionals from: Sincerely, Dio Lichiardopol Conference Production Director dlichiardopol@exlevents.com ExL Pharma Scott Grossman Division Head, Conference Production sgrossman@exlevents.com ExL Pharma CROs Institutional Review Boards Investigative Sites Data Management/Computer Software Companies Consulting Firms Sonesta Hotel Philadelphia 1800 Market Street Philadelphia, PA Room Reservations: If you require overnight accommodations, please contact the hotel to book your room. ExL Events has reserved a block of rooms at a discounted rate for conference participants. We encourage conference participants to make reservations by July 18, To make reservations guests can visit or call 800-SONESTA and request the negotiated rate for ExL s August Meetings. *ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL s reserved guest room block using the details provided.

3 DAY ONE MONDAY, AUGUST 8, :00 Registration and Continental Breakfast 8:45 CHAIRPERSON S OPENING REMARKS FOUNDATIONAL CHALLENGES 12:30 Luncheon 1:30 STRATEGIES TO CLARIFY STAKEHOLDER ROLES Collaborate with CROs on all inspection readiness activities Utilize proper communication channels to ensure all parties are on the same page Enforce an inspection-ready mentality across all stakeholders Larry Fish, Clinical Quality Control and Compliance Lead, CSL BEHRING 9:00 BEST PRACTICES FOR INSPECTION READINESS THROUGH A TRIAL S LIFE CYCLE Build inspection readiness through the whole life of a clinical trial Walk through problem areas, such as inadequate drug accountability, informed consent issues and adverse event reporting, to ensure that staff is trained to handle them Analyze relevant metrics from previous studies in order to improve your inspection readiness tactics Discuss what steps need to be taken after receiving a warning letter Ann Taylor, Associate Director, Clinical Development Quality, PFIZER 9:45 CASE STUDY: FOLLOWING GOOD CLINICAL PRACTICE STANDARDS WHEN DEALING WITH PROTOCOL, AMENDMENTS AND CHANGES Facilitate a companywide effort to promote pharmacovigilance inspection readiness Learn how to not have deviations from protocol when given amendments, protocols and investigator brochures that are not IRB approved Create comprehensive checklists for GCP to prepare for an internal audit Diane Palmer, Clinical Research Professional, Site Manager, COASTAL CONNECTICUT RESEARCH LLC 10:30 Networking Break 11:00 REGULATORY GUIDANCE AND STATUTES ACROSS THE INTERNATIONAL LANDSCAPE Understand the inspector s perspective and pinpoint the specifics of what they are looking for during an inspection Review ICH standards to ensure your company is keeping up with GCP guidelines Discuss site risk evaluation plans to examine site regulatory history and find any outstanding problems Nancy Bitters, GCP Inspection Manager, PFIZER PARTNERSHIP OUTSOURCING AND VENDOR MANAGEMENT 11:45 THE NECESSITY OF OUTSOURCING EFFECTIVELY IN ORDER TO MAKE VALUABLE PARTNERSHIPS Ensure proper vendor selection through practical alignment with internal processes Effectively navigate international regulations with appropriate vendor assignments Guarantee all parties are accountable through proper oversight and effective governance of case processing vendors Angela Berns, Clinical QA Director, Head of Vendor Management, UCB PHARMACEUTICALS 2:15 SELF-ASSESSMENT GUIDANCE FOR CLINICAL INVESTIGATORS AND SITE PERSONNEL TO PREPARE FOR INVESTIGATOR INSPECTIONS Evaluate whether adequate delegation and oversight strategies are in place Confirm that the critical requirements of trial conduct are ready for an inspection Ensure protocol and informed consent requirements are documented and retrievable for inspectors Structure methods for sponsor reporting Demonstrate that all Institutional Review Boards and Independent Ethics Committees reporting requirements are in compliance Establish compliance with drug accountability requirements Joyce Feldman, Director QA, Inspection, Risk Management Pharma Development, NOVARTIS 3:00 Networking Break 3:30 PANEL DISCUSSION: EFFECTIVE SITE SELECTION AND OPTIMIZATION PROCEDURES Prepare a site risk evaluation plan to ensure you choose the best partners Employ staff training techniques to reinforce an overall mindset of constant vigilance Analyze the inspection process to determine the most efficient methods of performing a mock inspection on sites Panelists: Angela Berns, Clinical QA Director, Head of Vendor Management, UCB PHARMACEUTICALS TMF AND ISF PREPARATION 4:15 BEGIN AND MAINTAIN A CONTINUOUSLY INSPECTION-READY TMF Implement a governance process that will cover the full life cycle of the TMF Pinpoint the critical components of keeping a TMF ready for inspection Utilize an information architecture system to ensure high-quality documentation Incorporate efficient SOPs to integrate the TMF across all partners Jamie Toth, Head of TMF Operations, DAIICHI SANKYO 5:00 Conclusion of Day One

4 DAY TWO TUESDAY, AUGUST 9, :00 Continental Breakfast 12:45 Luncheon 9:00 CHAIRPERSON S RECAP OF DAY ONE GLOBAL REGULATORY AND INSPECTION TRENDS 9:15 PANEL DISCUSSION: TMF INSPECTION EXPECTATIONS AND PREPARATION STRATEGIES Evaluate the common findings of incomplete TMFs Prepare for the protocols and procedures of an etmf inspection Explore TMF requirements from all regulatory authorities (i.e., the FDA, EMA, MHRA and PDMA) Panelists: Carol Stotesbury, TMF Manager, Clinical Records, GILEAD SCIENCES Pamela Perry, Director, Clinical Management, OTSUKA Stacey Basham, Assistant Director R&D GCP Quality Assurance, ABBVIE Tipsuda Kongtong, Senior Associate, Clinical Quality Assurance, EISAI 10:00 INCORPORATE THE ISF INTO THE OVERARCHING CLINICAL TRIAL TMF Compile a criteria checklist for a complete ISF Centralize operations to enable high-quality documents and synchronization with the trial TMF Establish procedures to implement continuous vigilance regarding the ISF Pamela Perry, Director, Clinical Management, OTSUKA 10:45 Networking Break AUDITS AND MOCK INSPECTIONS 1:45 AN ANALYSIS OF PAST AND PRESENT INSPECTION TRENDS IN PREPARATION FOR THE FUTURE Discuss the increase in the frequency of inspections in the last few years and how to manage it Consider the current trends in inspections and anticipate how they will evolve Study the changeover to electronic systems and how it will impact the industry Review past inspections and go over the discrepancies that existed Stacey Basham, Assistant Director R&D GCP Quality Assurance, ABBVIE 2:30 PANEL DISCUSSION: COMPLIANCE CONSIDERATIONS FOR INTERNATIONAL REGULATORY INSPECTIONS Recognize pharmacovigilance s increased importance and recent regulation changes Maintain inspection readiness in clinical sites located in emerging markets Manage risk and adhere to compliance standards in other countries through effective communication methods Moderated by: Steve Whittaker, Executive Director, THE AVOCA QUALITY CONSORTIUM Panelists: Three industry leaders from member companies of the Avoca Quality Consortium 3:30 Conference Concludes 11:15 QUALITY CHECKS AND AUDIT UTILIZATION TO PREPARE FOR AN INSPECTION Discuss methods for establishing a companywide inspection readiness system Utilize the self-audit process to determine what processes need improvement Apply quality checks throughout the self-audit process to ensure GCP standard adherence Presentation and resulting discussions were excellent. Resulted in several take-home messages. Manager, Clinical Quality, PFIZER 12:00 UTILIZE MOCK INSPECTIONS TO ENSURE YOUR COMPANY IS READY FOR YOUR NEXT INSPECTION Analyze key factors of the inspection process to learn how to perform an effective mock inspection Employ staff training techniques that will improve the overall efficiency of the process Practice mobilization plans for when you receive a notification of an impending clinical inspection Great presentations. Presenters were very engaging and provided good examples. Very detailed information, useful to bring back and implement immediately at our company. Senior Director, Clinical Operations, MERCK Director, Clinical Trial Oversight, ABBVIE

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