gcp conference
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Proactive GCP Compliance8th
Effective Risk-Based Approaches for Optimizing Clinical Quality and Achieving Inspection Readiness
April 5-7, 2017 | Sonesta Philadelphia Rittenhouse Square | Philadelphia, PA
Joanne Spallone Global Development Quality Audit Head NOVARTIS
CONFERENCE CHAIR
www.exlevents.com/gcp
THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE Conceptualizing the Future State of Clinical Quality and Compliance, and Taking Actions Today to Get There
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Sunil Kotecha, Director, Regulatory Inspection Management, PFIZER
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
Ann Meeker-O’Connell, Head, BioResearch Quality and Compliance, JOHNSON & JOHNSON
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Sponsors:
FEATURED SESSIONS
ALEXION CASE STUDY: QUALITY BY DESIGN Utilizing Quality by Design Principles to Optimize Compliance and Data IntegrityKathy Goldstein, Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALS
MERCK CASE STUDY, ONE YEAR LATER: SUCCESSFUL RBM IMPLEMENTATION Reporting on the Progress of Executing a Risk-Based Monitoring Approach and Effectively Overcoming Implementation Challenges Suzanne Lukac, Associate Director, Risk-Based Monitoring Implementation, MERCK
EISAI CASE STUDY: CLINICAL QUALITY MANAGEMENT PLAN Developing and Executing an Effective Clinical Quality Management Plan to Ensure GCP Compliance Fiona Jeitner, Senior Manager, Global Clinical Quality Assurance, EISAI INC. Twitter
#GCPConference
LinkedIn Proactive GCP Compliance Discussion Group
TRAINING OPTIMIZATION Optimizing Performance Effectiveness Through Harmonized Training Kristy Nease, Senior Director and Department Head of Clinical Compliance and Training, REGENERON PHARMACEUTICALS, INC.
AGENSYS CASE STUDY: TRIAL MASTER FILE Leveraging the Trial Master File as a Tool to Proactively Identify Risk Areas Jennifer J. Poulakos, Ph.D., Director, Development Quality Assurance, AGENSYS, INC., an affiliate of ASTELLAS PHARMA, INC.
®
www.exlevents.com/gcp
AUDIENCE PROFILE
2016 Audience Breakdown by Company Type
More Than 70% of the 2016 Audience Represented Director-Level and Above
2016 Audience Breakdown by Function
60%
20%
10%
10%
70%11%
17%
2%
70% - Pharma, Biotech, Device Companies
11% - CROs 17% - Other Clinical Service Providers 2% - Other
60% - Quality/Compliance 20% - Operations/Management 10% - Audits/Inspections 10% - Other
SPONSORSHIP AND EXHIBITION OPPORTUNITIES Do you want to spread the word about your organization’s solutions to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, participate as a panelist, moderate a roundtable, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that aligns with your specific thought leadership, education, business development and brand awareness goals. To learn more about these opportunities, contact:Justin KreamerBusiness Development Manager 917-932-0429 / [email protected]
WHO SHOULD ATTEND?
This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:
- Good Clinical Practice (GCP)- Clinical Quality Assurance (CQA)- Clinical Quality Control (CQC)- Clinical Trial Operations/Management- Clinical Research- Quality Management/Global Quality
Management- Audits/Inspections- Compliance/Global Compliance- Data Management/Systems Operations- Clinical Monitoring- Regulatory Affairs- Safety and Risk Management/Operations
This conference is also relevant to clinical QA, compliance and operations professionals from:
- Quality Service Providers and Consulting Companies
- Central, Imaging and ECG Labs - Investigative Sites - IRBs- Data Management and Software Vendors - Safety Reporting Vendors
Dear C ol league, Now in its eighth year, ExL’s Proactive GCP Compliance conference continues to act as the annual forum where senior-level clinical quality and clinical operations executives can gather, learn and discuss strategies to achieve and maintain global GCP compliance. In keeping with the industry’s changing needs, this year’s conference focuses on how companies are interpreting and responding to new global regulations, actions that are being taken to ensure data integrity, evolving monitoring methodologies and their impact on operations, and the development of effective strategies for achieving inspection readiness. Join us to learn how to proactively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety.
I look forward to greeting you in April, and don’t hesitate to contact me directly with any questions.
Sincerely,
Kristen Hunter Kristen Hunter, Event Director212-400-6241 // [email protected]
www.exlevents.com/gcp
Wednesday, April 5, 2017 // Full-Day Seminar
7:45 Registration and Continental Breakfast for Seminar Participants
8:30 THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE Conceptualizing the Future State of Clinical Quality and Compliance, and Taking Actions Today to Get There Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Sunil Kotecha, Director, Regulatory Inspection Management, PFIZER Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN Ann Meeker-O’Connell, Head, BioResearch Quality and Compliance, JOHNSON & JOHNSONChanging Regulations
• Evaluating the impact of global regulatory changes on clinical quality and compliance - Examining how ICH E6 R2 affects clinical quality and vendor oversight - Navigating the relevant ISO 14155 revisions - Discussing the new Clinical Trial Regulation’s replacement of the Directive
Predicting the Future of eClinical and eHealth• Defining the future state of quality data management and mapping out the process to get there
• Analyzing how eClinical and eHealth are evolving and how we can anticipate future changes
Evolving Inspections • Examining the changing landscape of regulatory inspections and the future of inspection management
• Identifying what countries and areas are undergoing the most significant changes in inspection processes
• Predicting how and where global regulatory inspections will continue to change Redefining Quality
• Outlining how today’s definition of quality differs from past definitions • Predicting how quality will continue to change• Assessing industry shifts and changes that impact how quality is defined • Exploring the role of quality by design (QbD) in driving compliance and effective risk management
12:00 Lunch for Seminar Participants1:00 THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND
COMPLIANCE (Continued) Assessing Compliance Needs Today and Tomorrow
• Outlining current compliance needs and wants from sponsors and CROs, and anticipating what their future needs and wants are likely to be
• Recognizing what metrics will and will not be meaningful as the compliance and regulatory landscapes evolve
• Addressing compliance at the patient level and the future of informed consent Discussing Actions That Need to Be Taken Today to Get to This Future State
• Discussing what shifts in variables mean for clinical compliance and quality today • Exploring how risk management is changing and the evolving roles of auditing and quality/compliance
• Embedding quality within operations to streamline processes and achieve compliance
4:30 Seminar Concludes
www.exlevents.com/gcp
Thursday, April 6, 2017 // Main Conference Day One
7:45 Registration and Continental Breakfast
8:30 CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE Joanne Spallone, Global Development Quality Audit Head, NOVARTIS
9:00 PANEL DISCUSSION: REGULATORY CHANGES TO GCP
Identifying the Regulations Driving Change in Clinical Quality and Compliance Operations and How Companies Are Responding Panelists:Kathy Goldstein, Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALSCheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGENMike Townsley, Director, Clinical Quality Assurance, TREVENA • Defining what regulatory changes are having the
greatest impact on GCP operations• Determining which global areas pose the most
challenges • Assessing how companies are responding to
regulatory changes and which operational changes have occurred as a result
• Predicting future regulatory changes, their impact and how to prepare today
10:00 Networking and Refreshment Break
10:30 APPLYING BEST PRACTICES FROM GMP Examining Operational Efficiencies Achieved in
the GMP Space and Effectively Translating Them to GCP Patricia Santos-Serrao, RAC, Market Segment Director, Global Pharmaceutical, Blood and Biologics, MASTERCONTROL • Recognizing that many commonplace methodologies
and practices in GMP achieve the same end results needed for GCP and can be repurposed and effectively implemented in the clinical space
• Evaluating effective vendor auditing approaches and how they can be used in GCP
• Incorporating methodologies for identifying deviations and assigning risk levels, and applying those methodologies to protocol review
• Designing a training approach that focuses on high-risk areas
• Walking through the CAPA methodology and applying similar processes to CAPAs in GCP operations
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11:15 ALEXION CASE STUDY: QUALITY BY DESIGN Utilizing Quality by Design Principles to Optimize
Compliance and Data Integrity Kathy Goldstein, Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALS • Defining quality in a clinical trial• Understanding the key principles of QbD• Using a closed-loop system to manage quality in a
clinical trial• Identifying, assessing and managing risk• Recognizing the challenges in implementing QbD at a
small to mid-sized company
12:15 Lunch
1:15 EISAI CASE STUDY: CLINICAL QUALITY MANAGEMENT PLAN
Developing and Executing an Effective Clinical Quality Management Plan to Ensure GCP Compliance Fiona Jeitner, Senior Manager, Global Clinical Quality Assurance, EISAI INC. • Evaluating the purpose of a clinical quality
management plan • Establishing objectives and drivers to design a clinical
quality management plan that meets your needs -Examining the critical components -Determining who should develop and oversee execution
• Incorporating tracking and trending techniques to mitigate risk throughout
2:00 CLINICAL DATA INTEGRITY Optimizing Data Integrity by Ensuring Compliant
Documentation of All Data Entries and Changes Nathalie Bourgouin, PMP, Director, SKILLPAD • Identifying the regulations driving an increased focus
on data integrity • Evaluating the results from site audits indicating
confusion about how changes should be tracked, documented and escalated
• Defining an internal quality approach with tools and systems
• Communicating your quality expectations to your CRO and site partners to guarantee data integrity
• Assigning proper roles, responsibilities and access to data to ensure integrity
• Conducting a gap analysis of processes to identify issues surrounding data integrity and develop process improvement measures
2:45 Networking and Refreshment Break
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www.exlevents.com/gcp
Thursday, April 6, 2017 // Main Conference Day One
Friday, April 7, 2017 // Main Conference Day Two
7:45 Registration and Continental Breakfast
8:30 CHAIRPERSON’S OPENING AND RECAP OF PREVIOUS DAYJoanne Spallone, Global Development Quality Audit Head, NOVARTIS
8:45 MERCK CASE STUDY, ONE YEAR LATER: SUCCESSFUL RBM IMPLEMENTATION
Reporting on the Progress of Executing a Risk-Based Monitoring Approach and Effectively Overcoming Implementation Challenges Suzanne Lukac, Associate Director, Risk-Based Monitoring Implementation, MERCK • Collaborating with stakeholders from different
functional areas to keep them engaged and invested
• Leveraging stakeholder influence to overcome challenges and obstacles
• Defining the approach and aligning team members through face-to-face workshops
• Structuring and assigning process implementation teams
• Successfully navigating vendor identification and selection
• Outlining the approach for pilot study selection-Assessing implementation in start-up studies versus ongoing studies
• Initiating a pilot and translating the results into RBM process improvements
• Designing a communication map for internal teams, CRAs, investigators and other partiesCA
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3:15 PANEL DISCUSSION: LEARNING FROM INSPECTIONS
Discussing Observations and Lessons Learned from Panelists’ Inspection Experiences and Providing Guidance to Optimize Preparation Efforts Panelists:Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Jennifer J. Poulakos, Ph.D., Director, Development Quality Assurance, AGENSYS, INC., an affiliate of ASTELLAS PHARMA, INC. Liz Szczesniak, Director of Compliance, Vaccines Clinical Research and Development, PFIZER• Evaluating recent inspection experiences and
observed trends • Assessing how inspections have changed regarding
what inspectors expect and require • Identifying common obstacles and challenges during
an inspection and strategies for overcoming them • Outlining best practices for managing expectations
and preparation strategies
4:15 ROUNDTABLE DISCUSSIONS Each conference participant selects one topic
from the following list to discuss in an intimate setting:
1. RESULTS OF RISK-BASED MONITORING: Examining the Outputs of RBM in Practice That Have Resulted in Changes
2. GMP VERSUS GCP: Delving into GMP Versus GCP Expectations
3. PATIENT ENGAGEMENT: Soliciting Feedback from Patients to Optimize Trial Design and Compliance
4. QA AND OPERATIONS COMPLIANCE: Discussing How to Have a Synergistic Existence
5. RISK CATEGORIES: Determining Different Categories of Risk
6. TMF INSPECTION READINESS: Implementing Best Practices to Ensure Your TMF Is Inspection-Ready
7. RISK MANAGEMENT BEST PRACTICES: Sharing Effective Strategies to Identify and Manage Risk
8. QUALITY CULTURE DEVELOPMENT: Establishing and Building a Culture of Quality
9. RISK-BASED AUDITING: Designing Auditing Plans That Focus Efforts on High-Risk Areas
10. REMOTE MONITORING: Discussing Methodologies for Proactively Ensuring Compliance When the Study Is Remotely Monitored
11. CLINICAL QUALITY METRICS: Evaluating How Metrics Are Driving Risk Management
12. CLINICAL SAFETY MANAGEMENT: Discussing Challenges for Compliant Clinical Safety Management and Reporting
13. COMPLIANCE DOCUMENTATION: Determining Effective Practices for Compliant Documentation of GCP
5:15 Day One Concludes
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“This is one of the few conferences that continually provides focused discussions amongst a diverse group. Once again I’ve gained many takeaways that my team will look at implementing.” – Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA
“This was probably the best industry conference I have attended. It was well worth attending and featured many talented speakers who shared their valuable expertise. I learned a great deal.”
– Lisa Murphy, Associate Director, R&D Compliance, BIOGEN
www.exlevents.com/gcp
MEDIA PARTNERS ASSOCIATION PARTNER
36OPMTHE FULL SPECTRUM OF PRODUCT MANAGEMENT
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Friday, April 7, 2017 // Main Conference Day Two
9:30 AGENSYS CASE STUDY: TRIAL MASTER FILE Leveraging the Trial Master File as a Tool to
Proactively Identify Risk Areas Jennifer J. Poulakos, Ph.D., Director, Development Quality Assurance, AGENSYS, INC., an affiliate of ASTELLAS PHARMA, INC. • Defining the purpose and understanding the value of
the trial master file (TMF) • Utilizing the TMF to identify areas of risk
-Conducting risk-based QC of the TMF -Performing ongoing TMF reviews -Examining the TMF for quality gaps
• Evaluating the role of the TMF during an inspection • Identifying best practices for maintaining an
inspection-ready TMF
10:15 Networking and Refreshment Break
10:45 PANEL DISCUSSION: VENDOR OVERSIGHT Discussing What Measures and Processes
Companies Are Taking to Ensure and Document Vendor OversightPanelists:Dwayne Brazelton, Director, Clinical Quality Assurance, MACROGENICS, INC.Dan Walsh, Director, Clinical Oversight, MYLANCheri Wilczek, President, CLINAUDITS, LLC• Assessing how companies define the scope of their
vendor oversight and whether oversight measures vary depending on the type of vendor
• Analyzing regulatory inspection observations related to vendor oversight
• Examining the tools in use to ensure proper oversight • Defining internal responsibilities to establish oversight
processes and safeguard their ongoing execution • Discussing documentation strategies to ensure
you can demonstrate effective oversight during an inspection
11:45 TRAINING OPTIMIZATION Optimizing Performance Effectiveness Through
Harmonized TrainingKristy Nease, Senior Director and Department Head of Clinical Compliance and Training, REGENERON PHARMACEUTICALS, INC.• Discussing traditional training methods and
understanding why they are no longer effective • Recognizing inefficiencies in training methodology
and the need for a harmonized approach • Determining which types of training methods meet
regulators’ expectations
12:30 Lunch
1:30 PANEL DISCUSSION: TOP CONCERNS AND CHALLENGES
Discussing the Biggest Challenges, Concerns and Obstacles to Achieving GCP Compliance Panelists: Katie Alberta, Global Head Clinical and Pharmacovigilance Quality, ALKERMES Anne Verrocchi, Senior Associate Director/Principal Auditor, BOEHRINGER INGELHEIMAdditional Panelists to Be Determined• Evaluating responses from pre-event audience polling
to determine which issues are the most important to discuss with this expert panel
• Exploring topics such as:-Ensuring a compliant TMF-Assessing proper clinical safety management -Verifying data integrity across stakeholders
2:30 CHAIRPERSON’S CONCLUDING REMARKSJoanne Spallone, Global Development Quality Audit Head, NOVARTIS
2:45 Close of Conference
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“The GCP Compliance conference delivered on all fronts. The speakers and attendees were knowledgeable and many were influencers or directors of strategy in their respective organizations. The mixed format (talks, workshops, panels, roundtables kept us all engaged and afforded excellent opportunities for the exchange of ideas as well as networking. I hope to be back next year!”
– Nicholas Hargaden, President, ALGORITHM, INC.
“One of the most vibrant and interactive conferences I have attended — it was most impressive and I am keen to attend next year!” - Nicky Dodsworth, Vice President, Global Quality Assurance,
PREMIER RESEARCH
www.exlevents.com/gcp
Additional Information
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Pricing information for the 8th Proactive GCP Compliance conferenceEARLY BIRD PRICING — Register by February 17, 2017
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Proactive GCP Compliance8th
Effective Risk-Based Approaches for Optimizing Clinical Quality and Achieving Inspection Readiness April 5-7, 2017 | Sonesta Philadelphia Rittenhouse Square | Philadelphia, PA
www.exlevents.com/gcp
Sponsors:
®
Twitter #GCPConference LinkedIn Proactive GCP Compliance Discussion Group
Joanne Spallone Global Development Quality Audit Head NOVARTIS
CONFERENCE CHAIRCASE STUDY PRESENTATIONS:〉 The Development of a Clinical Quality
Management Plan at Eisai
〉 RBM Implementation One Year Later at Merck
〉 Leveraging the TMF to Identify Risk at Agensys
〉 Quality by Design at Alexion
THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE
FULL
-DAY
SEM
INAR
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, BOSTON SCIENTIFIC
Sunil Kotecha, PFIZER
Cheryl McCarthy, RQAP-GCP, CQA, CBA, BIOGEN
Ann Meeker-O’Connell, JOHNSON & JOHNSON
Conceptualizing the Future State of Clinical Quality and Compliance, and Taking Actions Today to Get There