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Communication
Training
OversightMetrics
GCP
Site Mindset
CLINICAL TRIALS INSPECTION READINESS SUMMIT
3-4 May 2016 • Hilton London Kensington • London, UK
2ND EUROPEAN
THE ONLY EVENT FOCUSED ON GCP INSPECTION READINESS IN THE EU!
Remain inspection ready by planning your inspection tactics in advance, ensuring high document quality and improving preparation standards
TMF
TOP REASONS TO ATTEND:
• Ensure your inspection readiness SOPs are ready and will be effective in the event of an inspection
• Review regulations from around the world in order to stay up to date with regulatory agency expectations
• Utilize metrics to benchmark the success of your clinical trial and measure the performance of your CRO and trial sites
• Discuss the switch over to electronic files, and how this will affect the inspection process
• Analyze strategies to help organize files in a streamlined, comprehensive clinical trial storyboard so inspectors can recreate the trial
Inspection Readiness
Pramod Wable QA Manager, GCP, GLP,
DAIICHI SANKYO
Amer Alghabban Vice President GxP Quality
Assurance, Compliance Training,KARYOPHARM THERAPEUTICS
Nancy Meyerson-Hess Head Clinical Operations and
Compliance, GRUNENTHAL
Sameera Thanathparambil Senior Specialist, Quality
Assurance, JANSSEN
Joanne North Senior Director, Head of CDQA
Quality Data Analytics and Systems,
GLAXOSMITHKLINE
TO REGISTER: CALL +1 212-400-6227 OR VISIT WWW.EXLEVENTS.COM/EUROIR
VENUE: Hilton London Kensington 179-199 Holland Park Ave, London W11 4UL UK Phone +44 207-603-3355
Room Reservations: To make reservations please call +44 207-603-3355, option 1, and provide the group code ‘GEXLA’ to receive the negotiated rate. The group rate is available until 11 April 2016. Please book your room early as rooms available at this rate are limited.
*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 email us at [email protected]. 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.
CLINICAL TRIALS INSPECTION READINESS SUMMIT
2ND EUROPEAN
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/Monitoring/Research
• Trial Master Files
• Records/Data Management
• Clinical Trials Management
• Global Compliance
• Safety and Risk Management/Operations
• Auditing
• Clinical Project Management
• Clinical Development
• Clinical Document Coordination
• Clinical Site Management
• Global Regulatory Affairs
• CAPA Investigations
• Adverse Events
This conference is also of interest to:
• CROs
• Inspection Readiness Software Providers
• Data/Records/Archive Management Vendors
• TMF Vendors
• Quality Management Service Providers
• Electronic Signature Companies
SPONSORSHIP AND EXHIBITION OPPORTUNITIESDo you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact David Borrok, Business Development Manager, at +1 212-400-6234 or [email protected].
Dear C ol league,Having your clinical trial inspected can be very concerning for an organization unless you are properly prepared from the earliest stages. All inspections differ, and you need to be ready to handle everything from notification to execution, regardless of which regulatory authority conducts the inspection.
Clinical trial inspection readiness involves many elements, such as an inspection readiness plan, team training, site mindset and TMF completeness. One of the most challenging factors is proper oversight and communication between sponsors, CROs and research sites. Your entire organization needs to keep a mentality of constant vigilance in order to ensure compliance with good clinical practice guidelines. Industry adherence to GCP guidelines is essential; these inspections protect the rights, safety and welfare of the human research subjects participating in trials, and verify the accuracy and reliability of submitted trial data.
As technology continues to advance, we have access to ever-developing tools that can help ensure quality and give inspectors access to find and file documents electronically. While documents can be in electronic or paper form, there is currently a shift to bring everything to the digital world. The transition between the two formats has created an environment of uncertainty where inspectors are not necessarily familiar with the newest tools, which has led to concerns regarding how to train inspectors to use systems or technologies in a reasonable amount of time. Preparing for all possible scenarios — whether that means planning inspection logistics in advance or performing mock inspections — is a great way to make sure you are inspection ready.
The 2nd European Clinical Trials Inspection Readiness Summit will provide clinical trial sponsors, CROs and technology vendors with best practices in order to develop SOPs and quality control methods that will allow them to remain inspection ready. Join us this May in London to participate in thoughtful discussions with industry leaders, and gain knowledge that will help your organization be ready for its next inspection.
Sincerely,
Dio LichiardopolConference Production Director [email protected]
TO REGISTER: CALL +1 212-400-6227 OR VISIT WWW.EXLEVENTS.COM/EUROIR
8:00 REGISTRATION OPENS AND CONTINENTAL BREAKFAST
9:00 Co-Chairpersons’ Opening Remarks
Joanne North, Senior Director, Head of CDQA Quality Data Analytics and Systems, GLAXOSMITHKLINESameera Thanathparambil, Senior Specialist, Quality Assurance, JANSSEN
INSPECTION PREPARATION
9:15 Develop Best Practices for Designing SOPs that Will Allow for Inspection Readiness Preparation
• Create a document process to ensure all essential documents are filed properly
• Understand what QC needs to be performed across this document road map
• Recognize strategies to evaluate high-risk sites for inspection preparation
Emma Webby-Mears, Senior Clinical Document Manager, VECTURA
10:00 Quality Checks and Audit Utilization to Ensure Inspection Preparedness
• Analyze the most effective methods of providing an inspector with the information they request
• Utilize the self-audit process to evaluate your level of inspection readiness and determine what needs fixing
• Adopt useful quality checks and other measures to ensure that you comply with GCP standards through the entire process
• Put protection standards in place in order to keep information secure when sharing data
Michael Bean, Senior Director, Regulatory Compliance R&D, JANSSEN
10:45 NETWORKING BREAK
11:15 Sponsor Preparation for GCP Health Authority Inspections for NDA
• Focus on FDA and EMA procedures, and view the differences as they apply to emerging markets such as Taiwan
• Assess personnel qualifications and individual involvement in the trial
• Discuss computerized systems and trial master file readinessJuliet Dizon, Senior GCP Quality Assurance Manager, Global Quality Management, ACTELION
AUDIT AND RISK MANAGEMENT
12:00 Pharmacovigilance Audit and Inspection Readiness in the International Landscape
• Review methods of becoming audit or inspection ready• Understand the differences between the inspection objectives
of the various regulatory agencies in the global landscape• Determine ways to ensure an organization-wide effort for
pharmacovigilance inspection readiness• Practice approaches to establish an effective inspection
readiness systemAmer Alghabban, Vice President GxP Quality Assurance, Compliance Training, KARYOPHARM THERAPEUTICS
12:45 LUNCHEON
14:00 Risk Management Strategies for Good Clinical Practice
• Teach the correct site mentality of constant vigilance• Utilize a site risk evaluation to determine which partners to
work with most effectively• Learn about staff training techniques to ensure that they are
always ready for a clinical inspection• Identify the most common findings of inspections (protocol
noncompliance, inadequate/inaccurate records, etc.) and how to avoid them
Sameera Thanathparambil, Senior Specialist, Quality Assurance, JANSSEN
VENDOR AND STRATEGIC PARTNERSHIP OVERSIGHT
14:45 Vendor Management and Efficient Communication Methods to Improve Performance
• Collaborate with your CRO to set up mock inspection protocols
• Ensure your CRO and sponsor use proper communication channels
• Employ metrics to measure vendor success and benchmark their performance
Nancy Meyerson-Hess, Head Clinical Operations and Compliance, GRUNENTHAL
15:30 NETWORKING BREAK
16:00 Best Practices for Inspection Readiness Through Optimizing Your Ability to Gain Insights from Inspection- and Audit- Related Clinical Metrics
• Discuss trends in inspection findings so you can organize more efficiently in the future
• Analyze relevant metrics from previous in-house audits to improve your inspection readiness tactics
• Maximize presentation of metrics to enhance the overall process design
Joanne North, Senior Director, Head of CDQA Quality Data Analytics and Systems, GLAXOSMITHKLINE
16:45 DAY ONE CONCLUDES
DAY ONE | TUESDAY, 3 MAY 2016
“Throughly enjoyable and informative, I found the sessions very useful.”
—Senior Quality Assurance Specialist, JANSSEN
“Very good presenters who were engaging, which made the
material more interesting.” —Clinical Operations Manager, GLAXOSMITHKLINE
TO REGISTER: CALL +1 212-400-6227 OR VISIT WWW.EXLEVENTS.COM/EUROIR
8:00 CONTINENTAL BREAKFAST
9:00 Co-Chairpersons’ Recap of Day One
Joanne North, Senior Director, Head of CDQA Quality Data Analytics and Systems, GLAXOSMITHKLINESameera Thanathparambil, Senior Specialist, Quality Assurance, JANSSEN
9:15 Internalize the Importance of Inspector Direct Access and CRO Mindset
• Discuss how to transition to giving an inspector direct access so they can efficiently navigate the files they need
• Analyze methods of keeping your partners in the right mindset toward inspection readiness
• Review effective CRO oversight strategies• Consider approaches to a more standardized manner of
providing inspectors what they requireWendy Trimboli, Associate Director, TMF Process Management and Quality Control, EISAI
GLOBAL INSPECTIONS
10:00 Analysis of Risk Evaluation Mitigation Strategies in Preparation for an Inspection
• Address the utilization of a CRO with integrated pharmacovigilance services for the early clinical phases
• Ensure REMS program compliance with the necessary regulatory authorities in the beginning stages of clinical trials
• Assess program end-to-end effectiveness and overall efficiency regarding preparing for an inspection
10:45 NETWORKING BREAK
11:15 Management of EMA, FDA, MHRA and PMDA Regulatory Inspectorate Differences
• Analyze what is expected from each of these inspectorates• Determine the differences between each of the agencies• Identify methods of preparing for their respective inspectionsMartin Thorley, Senior Information Manager, PFIZER
TRIAL MASTER FILES
12:00 Strategies for Ensuring a Complete TMF
• Incorporate CRO oversight into the TMF governance process• Discuss the benefits of a centralized eTMF between the CRO
and sponsor• Develop efficient SOPs to integrate the TMF across all partners• Ensure quality and compliance when using an eTMF Siw Anehus, Senior GCP Advisor, LUNDBECK
12:45 LUNCHEON
13:45 Incorporate Continuous Vigilance for Your TMF to Maintain Inspection Readiness
• Evaluate inspection trends to improve TMF filing• Implement an overall governance process that incorporates
the entire TMF life cycle• Highlight the critical steps required to achieve inspection
readiness• Utilize tools to ensure your TMF is efficient and compliantPramod Wable, QA Manager, GCP, GLP, DAIICHI SANKYO
SITE PREPARATION AND MOCK INSPECTIONS
14:30 Panel: Best Practices for Mock Inspections to Ensure Your Internal Audits Are Effective
• Analyze the inspection process and learn how to effectively perform a mock inspection
• Coordinate with your vendors to ensure they are all up to date and ready for an inspection
• Examine mobilization plans for when notification of an impending inspection is received
Amer Alghabban, Vice President GxP Quality Assurance, Compliance Training, KARYOPHARM THERAPEUTICSNancy Meyerson-Hess, Head Clinical Operations and Compliance, GRUNENTHALSameera Thanathparambil, Senior Specialist, Quality Assurance, JANSSEN
15:15 Development of Site Risk Evaluation Plans for Effective Site Selection
• Gain information-gathering strategies for site selection before jumping into a clinical trial
• Review key factors to examine, such as site regulatory history, violations and outstanding audit items
• Mitigate risk when outsourcing clinical trials Rasa Bertuzis, Director, Clinical Operations, ROCHE
16:00 SUMMIT CONCLUDES
DAY TWO | WEDNESDAY, 4 MAY 2016
“Very effective, well delineated.”
—Vice President BD, PHLEXGLOBAL
“Throughly enjoyable and informative, I found the sessions very useful.”
—Senior Quality Assurance Specialist, JANSSEN
TO REGISTER: CALL +1 212-400-6227 OR VISIT WWW.EXLEVENTS.COM/EUROIR
REGISTRATION FEESEARLY BIRD RATES Register by 11 March 2016
Conference £1,295
STANDARD RATES Register After 11 March 2016
Conference £1,495
ONSITE RATES
Conference £1,695
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CLINICAL TRIALS INSPECTION READINESS SUMMIT
3-4 May 2016 • Hilton London Kensington • London, UK
2ND EUROPEANTHE ONLY EVENT FOCUSED ON GCP INSPECTION READINESS IN THE EU!
Remain inspection ready by planning your inspection logistics in advance, ensuring high document quality and improving preparation standards
Pramod Wable QA Manager, GCP, GLP,
DAIICHI SANKYO
Amer Alghabban Vice President GxP Quality
Assurance, Compliance Training,KARYOPHARM THERAPEUTICS
Nancy Meyerson-Hess Head Clinical Operations and
Compliance, GRUNENTHAL
Sameera Thanathparambil Senior Specialist, Quality
Assurance, JANSSEN
Joanne North Senior Director, Head of CDQA
Quality Data Analytics and Systems,
GLAXOSMITHKLINE
Conference Code: C777 Yes! Register me for the conference.
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TO REGISTER: CALL +1 212-400-6227 OR VISIT WWW.EXLEVENTS.COM/EUROIR
Phone: +1 212-400-6227 Online: www.exlevents.com/euroir
Email: [email protected]: ExL Events, Inc.
494 8th Avenue, Fourth Floor New York, NY 10001
