PANEL DISCUSSION TOPICS
Proactive GCP
Compliance
MARCH 24-25, 2015
Wyndham Philadelphia Historic District, Philadelphia, PA
• Quality by Design
• Risk-Based Monitoring
• Learning from Recent
Inspections
• Risk Management in
Global Studies
CONFERENCE CHAIR
Joanne Spallone
Global Head Clinical
Development
Quality Assurance
NOVARTIS
REPONDING TO FINDINGS
Effectively Responding to Critical Findings from Audits and/or Inspections to
Mitigate Risk
Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA
PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.
RISK-BASED AUDITING
Developing and Executing a Risk-Based Audit Approach to Optimize
Resources and Proactively Identify Areas of Noncompliance
Krista Kerr, Associate Director, Global R&D Quality & Compliance, JANSSEN
MANAGING CLINICAL CAPAs
Identifying and Utilizing Performance Metrics to Effectively Manage your
CAPA Process
Linda Sullivan, Owner & CEO, METRICS CHAMPION CONSORTIUM (MCC)
QUALITY DOCUMENTATION
Keeping and Maintaining Effective Documentation to Ensure and
Demonstrate GCP Compliance
Christine Block, Executive Director, QA-GCP, INCYTE CORPORATION
PANEL DISCUSSION: LEARNING FROM RECENT
INSPECTIONS
Experts Share Their Recent Inspection Experiences and What Lessons They
Have Learned
Moderator:
David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE
Panelists:
Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP, ALKERMES, INC.
Christine Block, Executive Director, QA-GCP, INCYTE CORPORATION
Suzanne Elliott, Director, PV Quality Management Compliance, VERTEX
PHARMACEUTICALS INC.
SPONSORS & EXHIBITORS:
• Clinical Risk Management
at Small and Mid-Sized
Companies
• GCP Education and
Training
INTERACTIVE WORKSHOPS
6
TH
ANNUAL
Effective Risk-Based Approaches for Optimizing Clinical Quality
FEATURED SESSIONS
ASSOCIATION PARTNER:
Dear Colleague,
Now in its sixth year,
Exl’s Proactive GCP Compliance
conference continues to act as the annual forum for
senior-level clinical quality and clinical operations
executives to gather, learn and discuss strategies to
achieve and maintain global GCP compliance.
Join us to learn how to effectively 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 seeing you in March and please don’t
hesitate to contact me with any questions.
Sincerely,
Kristen Hunter
Kristen Hunter
Event Director, ExL Pharma
Professionals from pharma, biotech and medical device
companies; CROs; and other clinical trial service providers whose responsibilities involve the following should attend this conference:
Who Should Attend?
Wyndham
Philadelphia
Historic District
400 Arch Street
Philadelphia, PA 19106
www.phillydowntownhotel.com
The Wyndham Philadelphia Historic District hotel is situated in the desirable and celebrated neighborhood of Old City Philadelphia. Philadelphia International Airport is a mere 12 miles away, and Philadelphia’s Central Business District is just a quick cab ride through scenic streets. Located one block from Market Street and a five-minute walk to many of the city’s iconic American Revolution landmarks — including Independence Hall and the Liberty Bell— this spacious hotel in Philly is a top choice for business and leisure travel. Take advantage of the adjacent parking garage, seasonal rooftop pool, fitness room and onsite dining, all provided with Wyndham’s signature upscale quality of service. To make reservations please call 1-877-999-3223 and request the negotiated rate for ExL’s March Meetings. You may also make
reservations online using the following weblink: http://bit.ly/1wOstWE. The group rate is available until March 2, 2015. Please book your room early as rooms available at this rate are limited.
2014 EVENT AUDIENCE BREAKDOWN
60% - Pharma, Biotech Device 12% - CROs
20% - Other Clinical Service Providers
6% - Sites 2% - Other
Who Attended Last Year?
Do You Want to Reach the
Audience at This Event?
If this audience represents your potential clients, then take
advantage of the opportunity to exhibit, present an educational
session, share your expertise on a panel discussion, host a
networking event and/or distribute promotional materials at
this event. ExL works closely with you to customize a package
that suits all of your needs. To learn more about these valuable
opportunities, please contact:
Andrew Sinetar
212-400-6237
[email protected]
“The 5th Annual 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.
• Good Clinical Practice (GCP) • Clinical Quality Assurance
(CQA)
• Clinical Quality Control (CQC) • Compliance/Global
Compliance
• Quality Management/ Global Quality Management • Clinical Operations/ Management • Clinical Monitoring • Audits/Inspections • Clinical Data • 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 50% - Quality/Compliance
35% - Operations/Management
5% - Audits/Inspections
10% - Other
ATTENDEE BY COMPANY TYPE
ATTENDEES BY FUNCTION
Day One – Tuesday, March 24
th
PANEL DISCUS
SION
CA
SE STUD
Y
WORKSHOP A
CLINICAL RISK MANAGEMENT AT
SMALL AND MID-SIZED COMPANIES
Effectively Designing and Executing Clinical Quality Risk Management
Approaches with Limited Resources
Tracey Douglass, MBA, Senior Manager, Development Quality, ALEXION R&D QA Kathy Goldstein, PharmD, CCRA, Director, Development Quality, ALEXION R&D QA
• Why a Risk-Based Approach?
§ Analyzing what a risk-based approach means at a smaller company and the potential benefits
§ Examining possible risk-based strategies for clinical quality management that make sense at a smaller company • Developing the Strategy/Plan
§ Effectively prioritizing clinical quality goals and creating applicable steps to achieve them
§ Performing a risk analysis of the program to determine where errors and challenges may occur
§ Reviewing available data, resources and infrastructure to determine what can be accomplished
§ Gaining internal buy-in along with external cooperation from CRO partners
§ Writing an effective risk-based management plan and identifying the critical components
• Executing the Strategy
§ Identifying key metrics to trend data and measure performance
§ Developing an effective oversight plan to ensure effective and compliant execution
§ Strategically monitoring site performance with available tools and resources
WORKSHOP B
GCP EDUCATION AND TRAINING
Moving Beyond Basic GCP Training to Education Methods that Support
Performance and Quality
Liz Wool, CCRA, CMT, President & CEO, QD-QUALITY AND TRAINING SOLUTIONS, INC.
• Examining GCP Training
§ Examining what the regulators — including the FDA, EMA and MHRA — are communicating and evaluating
§ Discussing why basic GCP training is no longer working
§ Understanding what types of training meet the expectations of the regulatory authorities
• Developing a Training Approach
§ Assessing your current training state and conducting a gap analysis to develop your training strategy
§ Determining if employees are deemed qualified for their roles and responsibilities
§ Designing effective education and training strategies to target role-based training requirements to meet regulatory expectations • Changing Training Needs
§ Examining the root cause of poor site performance to determine what training elements are needed
7:45 Registration Opens and Continental Breakfast for Workshop Participants
8:30 CHOOSE BETWEEN THE FOLLOWING WORKSHOPS
1:00 CHAIRPERSON’S OPENING REMARKS AND
INDUSTRY UPDATE
Joanne Spallone, Global Head, Clinical Development Quality Assurance, NOVARTIS
• Examining the changing culture of clinical research
• Evaluating the movement to optimize quality through risk-based approaches
1:30 CASE STUDY: PROACTIVE COMPLIANCE MODELS
Employing Proactive Approaches for Determining Potential
Problem Areas to Prevent Noncompliance and CAPA
Yvonne Barnes, Senior Director, Corporate Strategy Development, QUINTILES• Cost benefits of “building in” quality through prevention • Collecting the appropriate data to identify trends, determine
root causes and enact process improvements
• Developing proactive strategies based upon risks to prevent noncompliance
• Effective vendor oversight and documentation to identify potential issues
2:15 QUALITY BY DESIGN
Effective Strategies for Employing Quality by Design Principles to
Minimize Risk
Panelists:
Nicky Dodsworth, Vice President, Global Quality Assurance, PREMIER RESEARCH
Kelly Fenner, Associate Director, Portfolio Quality & Risk Management, PFIZER
Carlos Seminario, MD, Regional Director, GMD Clinical Operations, Site Management and Monitoring Americas, ASTRAZENECA PHARMACEUTICALS LP
• Defining the purpose, principles and concepts of quality by design (QbD), and its application in clinical research
• Developing strategies for implementing QbD in the clinical trial setting
§ Common implementation hurdles and how they were overcome
3:15 Networking and Refreshment Break
3:45 GxP COMPLIANCE STRATEGIES
Harmonizing GCP, GLP and GMP Compliance Strategies for
Continuous Process Improvement
Joe Goodman, Director, Solutions Consulting, SPARTA SYSTEMS
• Identifying the commonalities across GCP, GLP and GMP guidelines
• Examining how requirements transfer across each discipline • Evaluating the benefits to having one harmonized approach to
compliance
• Reviewing examples of how leading companies have created transparency across GxP
• Mitigating risk in an outsourced environment through one consistent compliance approach
4:30 QUALITY DOCUMENTATION
Keeping and Maintaining Effective Documentation to Ensure and
Demonstrate GCP Compliance
Christine Block, Executive Director, QA-GCP, INCYTE CORPORATION
• Identifying the critical documents needed to track and ensure compliance
• Determining who should be responsible for writing, owning and tracking documentation changes
• Deciding who should have access to which documents? (E.g. sites, vendors)
• Effective strategies for tracking and recording documentation changes
“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.”
10:00 30-Minute Networking and Refreshment Break
Day One – Tuesday, March 24
th
Day Two – Wednesday, March 25th
PANEL DISCUS
SION
PANEL DISCUS
SION
ROUNDT
ABLES
ROUNDT
ABLES
Each Conference Participant Selects One Topic to Discuss in an
Intimate Setting
1. RISK INDICATORS:Defining Risk Indicators that Proactively Identify Potential Areas of Noncompliance
2. AUDITING RISK-BASED MONITORED TRIALS:Best Practices and Challenges Where Auditing Trials where Risk-Based Monitoring/Management is Utilized
3. GCP QUALITY AGREEMENTS:Defining the Purpose of a Quality Agreement and the Critical Components
4. CLINICAL CAPAs:Best Practices for Defining, Developing and Executing Clinical Corrective and Preventive Actions
5. ESCALATION PLANS:Developing and Executing an Effective Escalation Plan to Mitigate Risks and Address Issues Appropriately
6. INTERNAL OPERATIONS:Ensuring Compliance and Clinical Teams Function and Communicate Effectively
7. FDA vs. EMA INSPECTIONS:Identifying the Different Areas of Focus and Interest when Being Inspected by the FDA vs. EMA 8. SMALL TO MID-SIZED COMPANY COMPLIANCE
CHALLENGES: Maintaining GCP Quality Standards in Clinical Research with Limited Resources
9. RISK-BASED MANAGEMENT PLAN:Identifying the Critical Components of a Successful Risk-Based Management Plan
7:30 Registration and Continental Breakfast for Conference Participants
8:15 CHAIRPERSON’S OPEN TO DAY TWO
Joanne Spallone, Global Head, Clinical Development Quality Assurance, NOVARTIS
8:30 RISK-BASED AUDITING
Developing and Executing a Risk-Based Audit Approach
to Optimize Resources and Proactively Identify Areas of
Noncompliance
Krista Kerr, Associate Director, Global R&D Quality & Compliance, JANSSEN
• Defining risk-based auditing and its relationship to traditional auditing
• Effectively utilizing risk-based auditing as a quality risk management tool
• Defining elements of a risk-based auditing plan
• Discussing best practices for effectively executing the risk-based auditing plan
• Evaluating the use of risk-based auditing in relation to recent noncompliance trends
9:15 RISK-BASED
MONITORING
Identifying the Challenges, Overcoming Obstacles and Sharing
Best Practices for Effective Execution of Risk-Based Monitoring
Panelists:
Yvonne Barnes, Senior Director, Corporate Strategy Development, QUINTILES
Krista Kerr, Associate Director, Global R&D Quality & Compliance, JANSSEN
Linda Sullivan, Owner & CEO, METRICS CHAMPION CONSORTIUM (MCC)
• Describe actions that have been taken at your company/ institution to enable effective risk-based monitoring • What are the challenges and obstacles associated with
risk-based monitoring and how are they being overcome? • How are sites handling this approach to monitoring? What
accommodations have been made at the site level? • What results have you seen from risk-based monitoring? • How are regulatory agencies viewing risk-based monitoring? • What are the best strategies for measuring the effectiveness of
risk-based monitoring?
10:15 Networking and Refreshment Break
10:45 PANEL DISCUSSION: LEARNING FROM RECENT
INSPECTIONS
Experts Share Their Recent Inspection Experiences and What
Lessons They Have Learned
Moderator:
David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE
Panelists:
Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP, ALKERMES, INC. Christine Block, Executive Director, QA-GCP, INCYTE CORPORATION Suzanne Elliott, Director, PV Quality Management Compliance, VERTEX PHARMACEUTICALS INC.
• Overview of panel’s recent inspection experiences
§ When was your inspection?
§ What agencies do you have recent experience with? • Do you feel there has been an increase in the number of
inspections and observations?
• What do regulatory agencies want to see or are requiring related to the quality management system (QMS)?
§ How are they evaluating the QMS?
• Identifying the differences between varying regulatory agency inspections and how that impacts preparation
• What lessons learned or advice would you give as a direct result of your inspection experience?
11:45 RESPONDING TO FINDINGS
Effectively Responding to Critical Findings from Audits and/or
Inspections to Generate an Action Plan that Mitigates Risk
Doreen McGirl, Associate Director, Clinical Quality Management, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.• Developing effective tools and methodologies for categorizing and prioritizing findings
§ Determining risk, criticality and if a CAPA is necessary • Defining actions based on the criticality of the findings and
deciding whether escalation and root cause investigation are necessary
• Utilizing risk-based decision-making to implement actions • Assigning appropriate levels of visibility regarding the findings
at sponsor, site and CRO
12:30 Lunch
1:30 MANAGING CLINICAL CAPAS
Identifying and Utilizing Performance Metrics to Effectively
Manage your CAPA Process
Linda Sullivan, Owner & CEO, METRICS CHAMPION CONSORTIUM (MCC)
• Defining the CAPA management process in clinical research • Assessing which metrics are critical to measure and improve
the CAPA process
• Integrating these metrics into your CAPA process to optimize management and streamline actions
• Utilizing the right metrics to drive improvement and prevent future CAPAs
5:30 ROUNDTABLE DISCUSSIONS
6:15 Close of Day One
“I found the conference offered a great balance of
presentations, workshops, panel and roundtable
discussions, attended by and facilitated by such a
talented group of experts – for me that was a winning
combination!”
– Anne Varker, Associate Director, ClinicalQuality Assurance, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
Important: Discount offers may not be combined. Discounts only apply to standard rate; early bird rate DOES NOT apply.
Make checks payable to ExL Events, Inc. and write code C521 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference.
Terms & Conditions
By registering for an ExL Events, Inc. (“ExL Pharma”) event, you agree to the following set of terms and conditions listed below:
Registration Fee: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.
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Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made.
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REGISTRATION INFORMATION
GROUP DISCOUNT PROGRAM
Save 25% per person when Registering Four
For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time) this is a savings of 25% per person.
Save 15% per person when Registering Three
Can only send three? You can still save 15% off of every registration.
To find out more on how you can take advantage of these group discounts, please call 866-207-6528.
QUESTIONS? COMMENTS?
• Do you have questions or comments on the agenda?
• Is there a specific topic missing that you would like to see addressed? • Would you like to get involved as a speaker, panelist or roundtable moderator? Please contact Kristen Hunter, Event Director, at 212-400-6241 or [email protected]. She is happy to discuss the above topics with you, as well as any other questions you may have about this program.
REGISTRATION FEES
EARLY BIRD PRICING REGISTER BY FRIDAY, FEBRUARY 6TH
Conference and Workshop $2,095
Conference Only $1,795
STANDARD PRICING REGISTER AFTER FEBRUARY 6TH
Conference and Workshop $2,295
Conference Only $1,995
ONSITE PRICING
Conference and Workshop $2,395
Conference Only $2,095
5 WAYS TO REGISTER
MEDIA PARTNERS
PANEL DISCUS
SION
2:15 RISK MANAGEMENT IN GLOBAL STUDIES
Effective Risk-Based Approaches for Maintaining GCP
Compliance when Working Internationally
Panelists:
Jessica Lee, Vice President, Clinical Operations & Compliance, INOVIO PHARMACEUICALS
Jodi Meck, Director, Clinical Quality and Process Management, MERCK Michael Sobczyk, Senior Director, Regulatory Compliance, GILEAD SCIENCES
• Evaluating the varying international definitions of GCP compliance
• Comparing international standards vs. country-specific regulations, guidances and practices
• Instituting strategies for staying current on important regulatory changes or updates that impact the compliance of global clinical studies
• Implementing risk-based strategies for selecting and overseeing vendors abroad
• Overcoming compliance challenges in emerging regions • Identifying quality challenges unique to the ASIAPAC region
3:15 Conference Concludes
