CLINICAL QUALITY O V E R S I G H T FORUM

October 15-17, 2014 – Sonesta Hotel, Philadelphia, PA
5th Annual
CLINICAL QUALITY
OVERSIGHT
FORUM
ENSURING TRIAL INTEGRITY BY EFFECTIVELY ASSESSING,
OPTIMIZING AND MANAGING THE QUALITY OF CLINICAL VENDORS AND SITES
FEATURED PRESENTATIONS
Conference Chair
Sharon Reinhard
Director, Clinical Operations &
Compliance
iCEUTICA, INC.
INDUSTRY UPDATE
Overview of Outsourcing Trends, Evaluating the
Drivers and Understanding the Impact on Clinical
Oversight Strategies
Mitchell Katz, PhD, Executive Director, Medical Research
EXPERT PANEL DISCUSSIONS:
Operations, PURDUE PHARMA
GCP Quality Management Systems
QUALITY BY DESIGN
Risk-Based Monitoring
Utilizing Protocol Design to Facilitate Quality
Oversight and Optimize Compliance
Effective Clinical Auditing
Donna Edgerton, Senior Director, Global Clinical Development,
Inspection Readiness
Compliance and Training, ALLERGAN
PFIZER CASE STUDY:
ASSESSING SITE HEALTH
HALF-DAY INTERACTIVE
WORKSHOPS:
Development and Early Implementation of a New
Site Health Assessment Program that Identifies
Risk Using Predictive Analytics
Quality Management Between Sponsors
and CROS
Risk-Based Auditing
Cheryl Small, Senior Director & Global Lead, Compliance,
Analytics and Intelligence, PFIZER
CASE STUDY: COMPREHENSIVE AUDIT
STRATEGY PLAN
Designing a Comprehensive Audit Consisting
of Multiple In-Process Vendor Audits and
Internal Process Audits to Effectively Determine
Compliance and Performance
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Sponsors and Exhibitors:
C O M P L I A N C E
IMPLEMENTATION SERVICES
Angela Berns, Director and Head of Vendor Management,
Clinical Quality Assurance, UCB BIOSCIENCES, INC.
Association Partners:
To Register Call 866-207-6528 or visit www.exlpharma.com/qualityoversight
1
5th Annual
CLINICAL QUALITY
OVERSIGHT
FORUM
ENSURING TRIAL INTEGRITY BY EFFECTIVELY ASSESSING,
OPTIMIZING AND MANAGING THE QUALITY OF CLINICAL VENDORS AND SITES
WHO SHOULD ATTEND?
The event is designed for C-Level, Vice President,
Director & Manager level executives at Pharma/Biotech/
Medical Device companies, CROs, and other Clinical
Service Providers with responsibilities in the following
areas:
•Q
uality Management/ Clinical Quality
Management
– Clinical Quality Assurance/ QA/ CQA
– Clinical Quality Control/ QC/ CQC
Dear Colleague,
•C
linical Operations/ Management/ Research/
Development
An effective clinical oversight strategy is critical to the success of your trial. With clinical
outsourcing at an all-time high and continuing to rise, risk-based monitoring and other riskdriven quality management approaches being implemented industry-wide, and new GCP
quality management systems and processes being adopted, the complexities are many and
the challenges great to effectively assessing, optimizing and managing the quality of your
clinical partners. Now in it’s celebrated 5th year, ExL’s Clinical Quality Oversight Forum
provides a unique interactive forum for clinical professionals to share, discuss and develop
ideas and strategies for identifying and mitigating clinical risk when working with clinical
vendors and sites.
•C
ompliance/Clinical Compliance/ Regulatory
Compliance
Join us and engage with like-minded professionals to take-away practical tools to improve
your clinical quality oversight strategies.
• Clinical Risk/ Risk Assessment
I look forward to greeting you in October and please don’t hesitate to contact me with any
questions.
• Medical Affairs
Sincerely,
Kristen Hunter
Event Director
212-400-6241
[email protected]
HOTEL INFORMATION
Sonesta Hotel Philadelphia
1800 Market Street
Philadelphia, PA 19103
Phone: (215) 561-7500
http://www.sonesta.com/Philadelphia/
The Sonesta Hotel Philadelphia offers a spectacular downtown location that is convenient to
whatever brings you to the city. Located near Rittenhouse Square, in Center City, the hotel
is within the business district and many popular Philadelphia attractions. With 445 well
appointed guest rooms, 24-hour fitness center, roof top swimming pool, and 16,000 square
feet of meeting space, the Sonesta Hotel Philadelphia is a wonderful location from which to
explore all that.
•M
onitoring/Site Management/ Study
Management
•C
linical Outsourcing/ Vendor Management/
Third Party Management
• Good Clinical Practice/ GCP
• Auditing/Auditor
• Regulatory Affairs
The event is also of interest to:
• Investigative Sites
• Academic Research Organizations
• Central, Imaging and ECG Labs
• IVRS Companies
• EDC Companies
• Other Clinical Service Providers
2013 AUDIENCE PROFILE
Attendees by Company
11%
65% Pharma, Biotech, Device
15%
65%
9%
Providers
To make reservations guests can call 800-766-3782 and request the negotiated rate for
“Exl’s October Meetings”
The group rate is available until September 23rd, 2014. Please book your room early as
rooms available at this rate are limited.
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.
11% CROs
15% Other Clinical Service
9% Other
Attendees by Department
14%
7%
32%
7% Clinical Quality/
4
Compliance
47%
2% Clinical Operations/
3
Management
% Outsourcing/ Supplier
7
Management
14% Other
2
WEDNESDAY, OCTOBER 15, 2014 WORKSHOPS
8:00Registration and Continental Breakfast for Conference Participants
8:30
12:00
Workshop Concludes/ Lunch for Morning Workshop Participants
WORKSHOP A: QUALITY MANAGEMENT BETWEEN
12:30
Registration for Afternoon Workshop
Approaches to Effective Oversight & Operationalizing
Best Practices for Quality Management between Sponsors
and CROs
1:00
WORKSHOP B: RISK-BASED AUDITING
Developing and Executing an Effective Risk-Based Auditing
Plan to Proactively Identify Risk and Ensure Site and
Vendor Compliance
SPONSORS AND CROs
Janis L. Hall, MBA, COP, Senior Consultant, THE AVOCA GROUP
Janice Hutt, Chief Operating Officer, THE AVOCA GROUP
Elizabeth Ronk Nelson, President, REGULATORY RISK
MANAGEMENT, LLC
• Aligning quality expectations between sponsors and CROs
• Defining what constitutes effective oversight
–Strategies for avoiding micromanagement and duplication of
efforts
• Auditing and monitoring: Separate (but complementary)
responsibilities for ensuring compliance
• Defining risk-based auditing and its relationship to traditional
auditing
• Effectively utilizing risk-based auditing as a quality risk
management tool
– Assessing risk when selecting vendors and sites
• Overview of the Quality Agreement core components and how to
operationalize the agreement
–Walk through the Avoca Quality Consortium’s Quality
Agreement template
–In-depth discussion of the areas of the Agreement that
generate the most discussion during negotiations regarding
quality expectations
–R
isk management through ongoing examination of metrics
and endpoints
– Setting risk acceptance thresholds
–Understanding how different companies are using these
Agreements
– Reporting on identified risk areas
• Elements of a risk-based auditing plan
– Comparison to the risk-based monitoring and vendor oversight
plan
• Sharing of relevant data from the Avoca Quality Consortium
benchmarking research and the eight-component framework for
effective oversight
• Lessons learned from the implementation of proactive approaches
to quality management and applying best practices for effective
oversight
• Engage in an interactive exercise where sponsors and CROs reverse
their roles in a mock meeting
–Discuss operationalizing best practices regarding quality to
ensure there is complete clarity from both the sponsor and
CRO perspectives
10:30
• Best practices for effectively executing the risk-based auditing plan
– Optimizing the timing
– Auditing of monitoring procedures and activities
– Adjusting the auditing plan based on collected data
• Evaluating the use of risk-based auditing in relation to recent
noncompliance trends
• Interactive exercise analyzing a protocol to identify areas of risk
and then developing an effective risk-based auditing plan
30-Minute Networking Break
2:30
30-Minute Networking Break
4:30
Workshop Concludes
THURSDAY, OCTOBER 16, 2014
7:30Registration and Continental Breakfast for Conference Participants
8:15
CHAIRPERSON’S WELCOME AND OPENING REMARKS
MAIN CONFERENCE
8:45 INDUSTRY UPDATE
Overview of Outsourcing Trends, Evaluating the Drivers and
Understanding the Impact on Clinical Oversight Strategies
Sharon Reinhard, Director, Clinical Operations & Compliance,
ICEUTICA, INC.
Mitchell Katz, PhD, Executive Director, Medical Research
Operations, PURDUE PHARMA
• Why is clinical oversight necessary?
• Elements to consider when determining the optimal level of
oversight
–Defining differences and similarities when overseeing
outsourced services such as monitoring, data management,
statistics, eDiary, labs, etc.
• Examining outsourcing trends for small, mid and large sized
companies and predictions for the future
–Breakdown of most common contracted services
3
–The impact of off-shoring on oversight strategies
• How are partnerships changing and what is the impact on
oversight?
• Understanding what’s driving these changes
–Regulatory and industry initiatives
–Effective risk-mitigation
• The impact of risk-based approaches to quality management on
oversight strategies
3
selection and qualification process and on an ongoing basis
–Identifying potential risk factors based on QMS assessment
9:30 SELECTION AND QUALIFICATION
Identifying Strategic Clinical Vendors and Minimizing Risks
through Effective Qualification
Dirk Roels, Director, Quality Assurance Analysis, Pharmaceutical
R&D Q&C, JANSSEN, PHARMACEUTICAL COMPANIES OF
JOHNSON & JOHNSON
• Effective strategies for identifying appropriate candidates from the
financial, business and quality perspectives
• Best practices for assessing capabilities and risks
–What questions to ask to determine capabilities, establish the
risk level, quality systems and appropriateness of a potential
partner
–Interpreting the response data and establishing a risk level
• When is a qualification assessment required and should some
partners be considered pre-qualified?
• Lessons learned from common vendor audit findings on how to
improve the selection and qualification process
10:15
• Challenges, pitfalls and lessons learned when implementing and
utilizing a QMS
12:30 Lunch
1:30 VENDOR OVERSIGHT CAPABILITY
Instituting a Vendor Oversight Capability to Ensure Vendor
Oversight is Properly Executed
Kirsten Morasco, Vice President, Clinical Quality & Compliance,
COMPLIANCE IMPLEMENTATION SERVICES (CIS)
• Defining vendor oversight capability within a holistic view of vendor
oversight
• Understanding the critical elements and benefits of a sustainable
vendor oversight capability
• Identifying the components of a vendor oversight capability
maturity model
• Assessing and implementing a vendor oversight capability within
your own organization
• Case study examples of improved oversight resulting from the
institution of a vendor oversight capability
Networking and Refreshment Break
10:45QUALITY BY DESIGN
Utilizing Protocol Design to Facilitate Quality Oversight and
Optimize Compliance
Donna Edgerton, Senior Director, Global Clinical Development,
Compliance and Training, ALLERGAN
FIZER CASE STUDY: ASSESSING SITE HEALTH
P
Development and Early Implementation of a New Site
Health Assessment Program that Identifies Risk Using
Predictive Analytics
2:15
• Recognizing the protocol as the primary tool to facilitate and
support quality conduct of the trial
• Examining elements of a the protocol design that can improve or
detract from compliance
–Assessing the protocol feasibility
Cheryl Small, Senior Director & Global Lead, Compliance, Analytics
and Intelligence, PFIZER
• Successfully moving from a retrospective “find and fix” method to a
proactive, predictive approach
• Harnessing big data from hundreds of studies and thousands of
sites to develop 4-5 algorithms that predict poor outcomes
–Evaluating what types of data are being used and why it was
determined that these key drivers predict poor outcomes
–Determining the clarity and complexity
• Optimizing site education and compliance through a well-designed
protocol
• Strategies for reducing the number of amendments
• Effectively communicating the importance of protocol design
internally to influence change, improve the process and optimize
clinical quality
11:30
PANEL DISCUSSION:
GCP QUALITY MANAGEMENT SYSTEMS
Optimizing Oversight through the use of Quality
Management Systems to Identify and Mitigate Risks
Moderator:
Katie D. Alberta, BSN, Global Head, CQA; GCP & GPvP,
ALKERMES, INC.
• Using the resulting data to influence site selection, resource
deployment, oversight and management processes
• Challenges, key takeaways, best practices and lessons learned from
early implementation
3:00
Networking and Refreshment Break
3:30
CASE STUDY: THIRD-PARTY QUALITY OVERSIGHT
Realizing the Operational Benefits to Utilizing a ThirdParty Quality Oversight Program
John R. Wilson, Jr., PhD, Senior Vice President, BEAUFORT LLC
• Utilizing a third-party to eliminate bias and achieving independence
to accurately assess performance
• A third-party quality oversight program as a complement to other
oversight activities, not effort duplication
–Allowing operational teams to focus on CAPA and quality
enhancing measures rather than administration of the process
Panelists:
Frances DeGennaro-Culver, Director, Clinical Research, Clinical
Quality & Process Management, MERCK
Margo Holland, Director, Quality Assurance GCP, VERTEX
PHARMACEUTICALS INC.
Dirk Roels, Director, Quality Assurance Analysis, Pharmaceutical
R&D Q&C, JANSSEN, PHARMACEUTICAL COMPANIES OF
JOHNSON & JOHNSON
Kevin J. Wilson, Manager-Medical Quality, Global Medical Quality
Systems, ELI LILLY & CO.
• What is a quality management system (QMS)?
–Defining the purpose, value, core and critical elements
• Examples of effectively utilizing a quality management system to
monitor organizational performance and trial execution of vendors
and sites
• Assessing vendor quality management systems early in the vendor
4
“
• Early process and operational improvements as a result of a thirdparty quality program
• Third-party quality oversight to facilitate an efficient inspection
readiness process
The conference was a positive open forum that provided an
opportunity for sponsors and vendors to come together and share
experiences, lessons learned, and identify a path to improve
sponsor oversight through better channels of communication.
- Maryann Livolsi, SHIRE PHARMACEUTICALS
4:15
PANEL DISCUSSION:
RISK-BASED MONITORING
Identifying and Managing Risk by Leveraging Clinical Data
to Target Monitoring Efforts
5:15
ROUNDTABLE DISCUSSIONS
Choose your preferred topic to discuss in an intimate setting.
1. E
FFECTIVE TRAINING: Identifying the Changing Training Needs
as Clinical Oversight Demands Evolve
2. eCLINICAL
VENDOR OVERSIGHT: Strategies for Effectively
Overseeing an eClinical Vendor to Ensure Quality and Performance
3. T
RIAL MASTER FILE: Effectively Utilizing a TMF or eTMF to
Oversee and Manage Clinical Quality of Vendors and Sites
4. D
OCUMENTING OVERSIGHT: Utilizing Simple Tools to
Effectively Document Oversight
5. E
SCALATION PLANS: Discussing the Critical Elements of
an Effective Issue Escalation Plan and Overcoming Execution
Obstacles
6. C
HANGING ROLES OF MONITORS & AUDITORS: Examining the
Evolving Roles of Monitoring and Auditing with the Development
of Risk-Based Oversight
7. R
ISK-BASED AUDITING: Defining Risk-Based Auditing, it’s
Impact on Oversight, and Best Practices for Execution
8. INTERNATIONAL OVERSIGHT: Best Practices for Overseeing
Quality when Working with Vendors and Sites on a Global Level
9. VENDOR CONTRACTS: How to Develop a Contract that
Effectively Incorporates Quality Requirement and Oversight
Expectations
10.SMALL TO MID-SIZED COMPANY CHALLENGES: Discussing
Resource Issues and Operational Concerns Unique to Smaller
Companies
6:00
Day Concludes
Moderator:
Kathy Goin, Vice President, Clinical Operations, TREVENA, INC.
Panelists:
Mitchell Katz, PhD, Executive Director, Medical Research
Operations, PURDUE PHARMA
Rivka Kerachsky, Director, Clinical Data Management, THEOREM
CLINICAL RESEARCH
Linda Sullivan, Chief Operating Officer, METRICS CHAMPION
CONSORTIUM
Howard Waxman, PhD, Director of Psychiatric Research, CRI
LIFETREE
• Defining risk-based monitoring and evaluating the pros and
the cons
– What are the risks associated with this approach?
– Should increased resources and time be allocated?
• Best practices for mapping out the process and developing a riskbased monitoring plan
– How was the workforce re-evaluated and applied?
– Determining changing training needs
• Examining clinical data and trends and adjusting monitoring efforts
based upon identified risks
• What does success look like? What are we standing to gain
through RBM?
FRIDAY, OCTOBER 17, 2014
MAIN CONFERENCE
7:45
Registration and Continental Breakfast for Conference Participants
9:15
8:15
Chairperson’s Introduction to Day
Sharon Reinhard, Director, Clinical Operations & Compliance,
ICEUTICA, INC.
8:30
PANEL DISCUSSION:
EFFECTIVE CLINICAL AUDITING
Developing and Executing an Audit Strategy as an Effective
Oversight Tool and Using the Findings to Generate Action
Plans to Mitigate Risk
Panelists:
Angela Berns, Director and Head of Vendor Management, Clinical
Quality Assurance, UCB BIOSCIENCES, INC.
CASE STUDY:
COMPREHENSIVE AUDIT STRATEGY PLAN
Designing a Comprehensive Audit Consisting of Multiple
In-Process Vendor Audits and Internal Process Audits to
Effectively Determine Compliance and Performance
Nicky Dodsworth, Vice President, Global Quality Assurance,
PREMIER RESEARCH
Cheri Wilczek, President, CLINAUDITS, LLC
Angela Berns, Director and Head of Vendor Management, Clinical
Quality Assurance, UCB BIOSCIENCES, INC.
• Identifying critical components of an effective audit plan
• Discussing the benefits of a risk-based auditing approach
• Strategies for assembling an effective assessment team to conduct
and manage auditing
• The importance of root cause analysis and effectiveness checks in
helping ensure repeat audit findings are reduced.
• Elevation of compliance issues to QA – how are these issues
incorporated into audit schedules?
• Coordinating audit activity and avoiding redundancies between
sponsor and CRO audits
• Identifying and measuring audit outputs and deliverables
• Interpreting the audit results and generating effective action items
to ensure compliance
5
• The components of the comprehensive audit and developing a
Master Audit Plan
• Assembling an effective assessment team to conduct and manage
the audits
• Identifying and measuring the outputs and deliverables of the
partnership
• Interpreting the audit yields and benefits
10:15
Networking & Refreshment Break
5
TRACK A
10:45
CASE STUDY: QUALITY AGREEMENTS
SMALL TO MID-SIZED COMPANY CHALLENGES
Developing an Effective Quality Agreement with your Clinical
Partner to Optimize Performance and Minimize Risk
Overcoming Oversight Challenges in Small to Mid-Size
Companies by Leveraging Resources, Data and Tools
Margo Holland, Director, Quality Assurance GCP, VERTEX
PHARMACEUTICALS INC.
Sharon Reinhard, Director, Clinical Operations & Compliance,
ICEUTICA, INC.
• Defining the purpose of the quality agreement
• What resources can be utilized to execute oversight activities?
• Comparing the quality agreement and contract
•M
aking metrics and data work for you to identify trends to focus
oversight activities
• Defining the critical elements to an effective quality agreement
11:30
TRACK B
• Walking through a sample agreement
• Utilizing simple tools to execute oversight activities
COMMUNICATION OPTIMIZATION & MANAGEMENT
VIRTUAL COMPANY CASE STUDY
Streamlining, Managing and Documenting Communication
between Sponsor, CRO and Investigator Site to Optimize Trial
Integrity
Design, Implementation and Management of an International
Risk-Based Oversight Program Focused on Quality
Performance at CRA and Site Levels
Jennifer J. Poulakos, PhD, Director, Development Quality Assurance,
AGENSYS INC., an affiliate of ASTELLAS PHARMA, INC.
Kimberly Feir Brooks, RN, BSN, RQAP-GCP, Former Quality Oversight
Program Lead, DURATA THERAPEUTICS
•D
eveloping a communication plan/strategy to ensure effective internal
and external communication
•W
hy the decision was made to implement a risk-based oversight
program
• Strategies
for documenting oversight to help navigate a Sponsor
Inspection
–Clearly defining internal and external roles and responsibilities for
executing and communicating oversight activities
•The use of risk management tools and metrics to identify when and
what type of communication is necessary
•E
nsuring all necessary parties are aware of milestones, deliverables
and when escalation is necessary
• Outlining the goals of the program and the intended accomplishments
• Developing
a Quality by Design cycle of consideration Plan-Do-CheckAct
• Identifying
key performance indicators to assess quality performance
standards
–Methods used to evaluate quality at the CRA and site levels
•R
eviewing the keep it simple and scientific principles when completing
a risk assessment
• Implementation results, challenges and lessons learned
12:15
Lunch
1:15 AMGEN CASE STUDY:
FUNCTIONAL SERVICE PROVIDER MODEL
Implementing a Global Functional Service Provider (FSP)
Model Focusing on Specific Roles to Effectively Oversee
Clinical Quality
Moderator:
Donna Edgerton, Senior Director, Global Clinical Development,
Compliance and Training, ALLERGAN
Panelists:
Dwayne Brazelton, Director, Clinical Quality Assurance,
MACROGENICS, INC.
Karen Koroly RN, BSN, Clinical Site Management, Oversight
Manager, AMGEN
Suzanne Elliott, Director, PV Quality Management Compliance,
VERTEX PHARMACEUTICALS INC.
• Defining the FSP model and how it contributes to Amgen’s clinical
trial execution platform
• How the FSP model is used to measure and maintain clinical
quality
• The core oversight and support roles and their responsibilities
• Overview of the global supplier governance structure
• Defining key performance indicators to manage supplier
performance
• Key developments over the past year
2:00 PANEL DISCUSSION: INSPECTION READINESS
A Retrospective Examination of How Oversight Techniques
Could Have Been Improved to Optimize the Inspection
Experience
QUESTIONS? COMMENTS?
Jennifer J. Poulakos, PhD, Director, Development Quality
Assurance, AGENSYS INC., an affiliate of ASTELLAS PHARMA,
INC.
• Overview of each panelist’s experiences with inspections and their
outcome
• What oversight techniques worked and didn’t work to ensure
inspection readiness at the site level?
• What specific lessons did you learn from your inspection
experiences?
• Is there anything you would you have done differently to prepare?
3:00
Close of Conference
• 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 Event Director, Kristen Hunter at 212-400-6241 or [email protected] and she’d be happy
to discuss with you any of the above or any other questions that you might have on this program.
6
REGISTRATION INFORMATION
Registration Fees for Attending
ExL’s 5th Clinical Quality Oversight Forum:
Early Bird Pricing
Register by Friday, August 29th
Conference and Both Workshops - $2,395
Conference and One Workshop - $2,095
Conference Only - $1,795
Payment: Must be received in full by the conference date. All discounts
will be applied to the Conference Only fee (excluding add-ons)‚ cannot be
combined with any other offer‚ and must be paid in full at the time of order.
Group discounts available to individuals must be registered simultaneously and
employed by the same organization.
Cancellation and Refund Policy
If you need to cancel your registration for an upcoming ExL event, please note
the following policies derived from the Start Date of the event:
• Four weeks or more:A full refund (minus a $295 processing fee) or a voucher
to another ExL event valid for 18 months from the voucher issue date.
• Less than four weeks: A voucher to another ExL event valid for 18 months
from the voucher issue date
• If you cancel at any time after receiving the conference documentation, the
voucher issued will be $395 less
Standard Pricing - Register After August 29th
Conference and Both Workshops - $2,595
Conference and One Workshop - $2,295
Conference Only - $1,995
Onsite Pricing
Conference and Both Workshops - $2,695
Conference and One Workshop - $2,395
Conference Only - $2,095
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 4 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,
contact
our offices at (201) 871-0474.
please call
866-207-6528.
Important: Discount offers may not be combined. Discounts only apply to
standard rate, early bird rate DOES NOT apply.
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7
36O
PM
THE FULL SPECTRUM OF PRODUCT MANAGEMENT
7
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egister me for the Conference and Workshop B (RiskBased Auditing)
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