2
4
9
20
70 +
225 +
1,600 +
Countless
See page 18 for a list of these opportunities
2 ISPE Annual Meeting 2015
4
5
6
7
8-9
10-11
14-16
17
18-19
20
21
CONNECT SHARE FOLLOW #ISPEAM15
Be the First to See it, Discuss it, and Use it!
Take Drug Shortages Prevention from Theory to Practice
Easy-To-Use Tool for Self-Assessment and Continual Improvement
Increase Supply Reliability
The tool is designed to help industry mitigate supply chain problems, prevent negative impacts of shortages on patients, and identify gaps in manufacturing production and quality systems.
Only ISPE Members and Conference Attendees will have access to this complimentary resource!
Business Continuity Planning for the Prevention of Drug Shortages: Introducing the ISPE Drug
Shortage Assessment and Prevention Tool www.ISPE.org/2015-Annual-Meeting 3

Latest Trends from FDA in
Compliance, Enforcement, cGMPs and Quality Systems
Baxter’s Integrated Plasma
Protein Manufacturing Facility:
The Home Stretch
Successful Delivery of a Large-Scale
Pharmaceutical Facility in China
Asia-Pacific GMP Update and Outlook
• Innovative Technologies in China
• Implementation Challenges and Solutions
Asia-Pacific Sessions Sponsored by:
2015 FOYA Winners’ Presentations
Program
Sponsored by:
Updated Sessions and Case Studies
Along with Data Integrity, Process
Capability & Validation, Quality
Metrics, Drug Shortages, Single-Use
Technologies, Barrier and Aseptic
Systems, Breakthrough Therapy, Risk
Management, Continuous Processing and Clinical-Phase Products, Patients and Technologies
4 ISPE Annual Meeting 2015
ISPE leaders and featured speakers kick off this year’s meeting by addressing your top concerns.
Sponsored by:
Kathryn Wengel
Vice President
Johnson & Johnson Supply Chain
Quality as a Competitive Advantage in Supply Chain
John G. Cox
Executive Vice President
Pharmaceutical Operations and Technology
Biogen
Transforming Biologics Manufacturing to Deliver on a Global Biopharmaceutical
Pipeline: Biogen’s Strategy for
Success through Innovation
International and US FDA regulators weigh in on the biggest challenges facing the industry: harmonization, data integrity and quality risk management. Be there to lend your voice to the discussion.
Interactive sessions focus on unique projects, technologies and approaches that clearly demonstrate how companies have successfully adopted innovation as a benefit rather than as a risk. Does your organization foster a culture that supports innovation?
Visit the website for the most updated schedule: www.ISPE.org/2015-Annual-Meeting
08.30 – 09.30 Student Poster Competition Set-Up
12 .30 – 13.30
Young Professionals/Student
Luncheon and Orientation
15.0 0 – 17.00
Opening Keynote Session with Kathryn
Wengel and John Cox
17. 0 0 – 19.00
Welcome Reception in the Exhibit Hall
07.0 0 – 08.00
7th Annual ISPE Charity 5k Run/Walk
0 7.15 – 08.15
New Member and First-Time Attendee
Orientation and Networking Breakfast
0 8 .15 – 08.30
Young Professionals
Meet and Greet
08.30 – 10.00
Facility of the Year (FOYA) 2015
Category Winners Education Session
08.30 – 10.00
Education Sessions
10.0 0 – 10.45
Networking Break in the Exhibit Hall
10.45 – 12.15
Education Sessions
12 .15 – 13.30
Lunch in the Exhibit Hall
13.30 – 15.00
Education Sessions
13.30 – 17.00
International Student Poster Competition
15.0 0 – 16.00
Networking Break in the Exhibit Hall
16.0 0 – 17.30
Global Regulatory Town Hall
17. 3 0 – 18.30
Mix and Mingle Reception in the Exhibit Hall
19.30 – 22.00
Young Professionals Event at Lucky Strike
CONNECT SHARE FOLLOW #ISPEAM15
07. 3 0 – 07.45
Young Professionals
Meet and Greet
08.00 – 10.00
Membership Breakfast and Awards
10.0 0 – 10.45
Networking Break in the Exhibit Hall
10.45 – 12.15
Education Sessions
12 .15 – 13.30
Lunch in the Exhibit Hall
13.30 – 15.00
Education Sessions
15.0 0 – 16.00
Networking Break in the Exhibit Hall
16.0 0 – 17.30
Education Sessions
19.0 0 – 22.00
Tuesday Night Party at Reading
Terminal Market
08.30 – 10.00
Education Sessions
10.0 0 – 10.30
Networking Break
10.30 – 12.00
Education Sessions
Facility Tours
09.00 – 20.00
Facility Tour III
AstraZeneca’s New Formulation Suite
09.40 – 20.00
Facility Tour II
Morphotek’s 2013 Sustainability Facility of the Year Category Winner
10.0 0 – 16.00
Facility Tour I
Merck’s Gardasil Vaccine
Production Facility
Sessions marked (Y) are sessions that may be of interest to
Young Professional and Student members.
Times Subject to Change www.ISPE.org/2015-Annual-Meeting 5

Kathryn Wengel
Vice President
Johnson & Johnson Supply Chain
Ms. Wengel serves on the
Johnson & Johnson Management
Committee and chairs the
JJSC Leadership Team. She is also a Johnson & Johnson leadership member of the Regulatory Compliance and Government
Affairs Committee and the Science, Technology and Sustainability Committee of the Johnson &
Johnson Board of Directors. Ms. Wengel has enterprise leadership responsibility for all aspects of Supply Chain, including accelerating Johnson &
Johnson’s innovation and growth objectives, building and leveraging capabilities that meet the diverse needs of the business, and enabling the delivery of a reliable supply of high-quality products and services to customers around the world.
John G. Cox
Executive Vice President
Pharmaceutical Operations and Technology
Biogen
Mr. Cox oversees Biogen’s production facilities, supply chain operations, technical development, quality and engineering around the globe. Mr. Cox brings more than 20 years of experience in biopharmaceuticals with roles of increasing responsibility at Biogen
Idec. He has led the operations of two world-class biopharmaceutical manufacturing facilities, and has overseen small-scale cell culture and purification laboratories, along with the start-up of a pilot facility. Additionally, Mr. Cox held a number of senior roles at Diosynth, Inc. and Wyeth
Corporation, where he worked in technology transfer, validation and purification.
Program sponsored by:
Overall Winner to be announced during the Membership Breakfast and Awards
Learn about the innovative projects from the 2015 Facility of the Year Awards Category
Winners. The FOYA Program recognizes state-of-the-art pharmaceutical manufacturing projects utilizing new and innovative technologies to improve product quality, reduce cost and demonstrate advances in project delivery.
6 ISPE Annual Meeting 2015
With more than 1,600 pharmaceutical professionals in attendance each year, ISPE Annual Meeting brings together industry leaders and decision makers eager to see the latest technology and innovative solutions for their businesses.
By sponsoring or exhibiting at the event, you will gain recognition and the opportunity to develop relationships with leading industry professionals.
Don’t miss the chance to reserve your space and take advantage of the many sponsorship opportunities before they sell out.
A limited number of exhibit spaces and sponsorships are still available. For more information, contact Alisa
Pachella, Account Manager at apachella@ispe.org or
+1-813-739-2274.
Visit identified Exhibit Hall Giveaway Sponsors’ Table
Top Exhibits and have your entry card stamped.
Drop your completed card into the drawing tumbler for a chance to win one of several prizes.
Must be present to win. Only registered education or training attendees are eligible.
Exhibitor Set-Up
Exhibit Hall Opens with the Welcome Reception
17.00 – 19.00
08.00 – 16.00
17.00 – 19.00
09.30 – 18.30
Networking Break in the Exhibit Hall 10.00 – 10.45
Lunch Served in the Exhibit Hall
Networking Break in the Exhibit Hall
12.15 – 13.30
15.00 – 16.00
Mix & Mingle Reception in the Exhibit Hall 17.30 – 18.30
09.30 – 16.00
Networking Break in the Exhibit Hall 10.00 – 10.45
12.15 – 13.30
Lunch in the Exhibit Hall
Networking Break in the Exhibit Hall
Exhibitor Move-out Begins
15.00 – 16.00
16.15
Exhibit Hall Walk-through Passes are not available.
www.ISPE.org/2015-Annual-Meeting 7
CONNECT SHARE FOLLOW #ISPEAM15

Go to the website for full list of sessions, descriptions and a speaker list. www.ISPE.org/2015-Annual-Meeting/Learn
Facilities and Equipment
Gain a better understanding of the challenges presented to owners/users throughout the global biopharmaceutical industry. Learn how to confront diverse issues affecting facility design, construction and operation, and how to utilize innovations in processing technology, such as single-use manufacturing equipment and techniques.
SELECTED SESSION TOPICS:
• Critical Utilities Optimization
• Sustainable Development/Sustainability
• Risk-Based Qualification for the 21st Century
• Implementing Single-Use Technology
• Upgrading/Decommissioning of Existing Facilities
Product Development and Production Systems
Explore lessons learned surrounding the challenges of Single-Use, Continuous Processing, Aseptic and
Barrier Isolator technologies. Prepare to deal with the significant containment issues related to the new class of products – Antibody Drug Conjugates. Learn to recognize capacity improvement opportunities and re-think your established processing of Oral
Solid Dosage products. Discover new approaches for effective delivery of complex Commissioning and Qualification requirements and strategies for successful product launches.
SELECTED SESSION TOPICS:
• Product Launches
• Continuous Processing
• Commissioning and Qualification
• Workflows and New Technologies
• Next Generation Manufacturing
8
Go to the website for full list of sessions, descriptions and a speaker list. www.ISPE.org/2015-Annual-Meeting/Learn
ISPE Annual Meeting 2015
End-to-End Supply Chain Management
Experience practical applications and real-world insights from industry leaders as they share their knowledge and experience as it relates to clinical sites and patient usage. Hear from US and EU regulators, patients and special guests from the US Customs and Border Protection.
SELECTED SESSION TOPICS:
• Patient Testimonials from Clinical Trials
• Customs and Border Patrol
• Counterfeit Medicines
• eLabels
• Policy Influence on the Supply Chain
Regulatory Compliance and Quality Systems
Hear from global regulators regarding the changes facing their organizations and how those changes will impact your company. From the perspectives of FDA, EMA, MHRA and PMDA, gain an understanding of how emerging regulations, developing guidance and new enforcement practices may alter your strategies for assuring product quality with an eye toward efficiency.
SELECTED SESSION TOPICS:
• Quality Metrics
• Preventing Drug Shortages
• International Regulatory Updates
• Breakthrough Therapy
• Data Integrity
CONNECT SHARE FOLLOW #ISPEAM15
Information Systems
Information systems technology and approaches continue to rapidly evolve. This constant change has caused increased application and utilization, which in turn has created additional challenges, new expectations, and heightened scrutiny from regulatory agencies worldwide. Gain a heightened understanding of current trends in information systems that impact our industry’s regulatory landscape.
SELECTED SESSION TOPICS:
• Data Integrity
• R&D/Clinical Systems
• Regulated Mobile Applications
• Serialization/Track and Trace
• Cloud Computing
Innovation Forum
Novel and unique ideas on how our highly regulated and competitive industry can adopt innovation as a benefit—and not as a risk—will be the focus of the
Forum. Learn through case studies, discussions, workshops and roundtables how to foster a culture that supports innovation within your own organization.
SELECTED SESSION TOPICS:
• Behavior of Your Workforce
• Hybrid Facilities
• Project Capital Efficiency
• Innovative Project Execution in China
• Implementing New Systems www.ISPE.org/2015-Annual-Meeting 9

15.00 - 17.00
Opening Keynote Session
17.00 - 19.00
Welcome Reception in Exhibit Hall
07.15 - 08.15
New Member and First-Time Attendee Breakfast
Managing Abstract Elements Beyond Facilities
Facility of the Year (FOYA) 2015 Category Winners
Education Session
Combination Products: Same Vocabulary, Different
Interpretation
Latest Trends from the FDA in Compliance,
Enforcement, cGMPS and Quality Systems, and
Industry’s Perspective and Challenges
Lessons Learned from Implementing Single-Use
Technology
Pragmatic Approaches to Data Integrity - Part 1
Patient Perceptions of Investigational Medicinal
Products from 2015 Survey Results with Real
World Applications from Takeda
Innovation Forum: The Future of Pharma
Manufacturing – The Next 100 Years
10.00 - 10.45
Networking Break In the Exhibit Hall
A Decade of Data – Facility of the Year (FOYA)
Aggregate Metrics
Case Study of 12 Flexible Facility Biopharm Projects
Hot Topics in Validation - Part 1
Business Continuity Planning/ISPE Drug Shortage
Assessment and Prevention Tool
Impact of Single-Use Manufacturing on Process
Development
Current Trends in Barrier and Aseptic Technologies
Pragmatic Approaches to Data Integrity - Part 2
Part 1 - Turning the Page from Patient Unfriendly to Patient Friendly; Part 2 - Monitoring and
Enhancing Compliance in Clinical Trials
Innovation Forum: Moving Beyond Paradigm
Paralysis
12.15 - 13.30
Lunch in the Exhibit Hall
GMP in Aging Facilities and Upgrade of Existing Facilities
The Latest OSD Regulation Requirements and Technologies for Pharma Operations
Baxter Integrated Plasma Protein Manufacturing
Facility: The Home Stretch
Times Subject to Change
Current Data Integrity Trends
– A Regulatory and Compliance Perspective
Hot Topics in Validation - Part 2
Single-Use Standardization Update
– An Interactive Panel Discussion
Compliant Regulated Mobile Applications
Part 1 - Patient Testimonials from Clinical Trials
Part 2 - Clinical Supplies and Investigator Site
Innovation Forum:
Part 1 - Rapid Deployment Modular OSD Unit
Operations; Part 2 - Hybrid Facilities
15.00 - 16.00
Networking Break in the Exhibit Hall
16.00 - 17.30
Global Regulatory Town Hall
17.30 - 18.30
Mix and Mingle Reception in the Exhibit Hall
19.30 - 22.00
Young Professionals Event at Lucky Strike
08.00 - 10.00
Membership Breakfast and Awards
10.00 - 10.45
Networking Break in the Exhibit Hall
Critical Utilities Maintenance Program and Operational Optimization
Implementing Single-Use Technology for Biomanufacturing
Cross Contamination: Dedication, Segregation or Other?
Process Capability for Continuous Improvement
- Part 1
Adoption of Quality Risk Management Principles in Breakthrough Therapy
Successful Product Launches
Specialized eClinical Solutions for Clinical
Trial Processes
Part 1 - Customs and Border Protection (CBP) and Roundtable; Part 2 - How Trade Regulations and Policy Influence the Supply Chain
Innovation Forum:
Part 1 - IT Roadmap for 21st Century and Beyond;
Part 2 - Preventing and Governing Orphan Data
12.15 - 13.30
Lunch in the Exhibit Hall
Biomanufacturing: The Convergence of Continuous
Processing and Single-Use Technology
Effective Integration of Environmental Health and
Safety Requirements into Project Design Review
FDA Update from the Office of Pharmaceutical
Quality
Process Capability for Continuous Improvement
- Part 2
10 ISPE Annual Meeting 2015
New Directions in Continuous Process for MAb Manufacturing
Biomanufacturing Facility Capacity Improvement
Using Process Modelling
Clinical Data Archiving and eTMF Migration
Case Study
Part 1 - Counterfeit Medicines;
Part 2 - Current Status and Trends on Serialization and Track & Trace
Innovation Forum:
Part 1 - Asia-Pacific GMP Update & Outlook;
Part 2 - Innovative Technologies in China
15.00 - 16.00
Networking Break in the Exhibit Hall
HVAC Sustainability
Decommissioning Pharmaceutical Equipment and Facilities
International Regulatory Updates
Case Studies in Suspect Product Notification
Reporting
C&Q Project Management – The Ultimate Challenge!
Development Workflows and Emerging
Technologies in Continuous Processing
The Challenge of IT Infrastructure
Part 1 - Round Table on Counterfeit Medicines;
Part 2 - Regulatory Challenges with the EU
(Annex 6);
Part 3 - Metrics for Clinical Trials
Innovation Forum:
Part 1 - Innovative Process for Expeditious
Preparation of Capital Appropriation Packages for the BioPharm Industry;
Part 2 - A New Approach to Improve Major
Pharmaceutical Project Capital Efficiency
19.00 - 22.00
Tuesday Night Party at Reading Terminal Market
Networking, Lunch, Tours
Facilities and Equipment Track
Regulatory Compliance and Quality Systems Track
Product Development and Production Systems Track
Information Systems Track
End-to-End Supply Chain Management Track
Innovation Forum Track
09.00 - 20.00
Risk-Based Qualification – 10 Years After the
Landmark ISPE White Paper on Risk-Based
Qualification for the 21st Century
Quality Metrics - Part 1
Applying Risk-Based Validation to Move to an
ASTM E2500
Advances in Next Generation Manufacturing
PAT in Raw Materials
Improving Your Interactions with Cloud Providers
Current Status and Trends on Serialization and
Track & Trace - Part 1
Part 1 - Real World Experiences with E-labeling;
Part 2 - English Only on Primary Packs and
E-labels;
Part 3 - Transcelate Update on E-labeling
Innovation Forum: Achieving Innovation in
Science Facilities Design – Providing High Value,
Innovative Design and Delivery Strategies with
Fixed Project Constraints
Facility Tour III - AstraZeneca
09.40 - 20.00
Facility Tour II - Morphotek
10.00 - 16.00
Facility Tour I - Merck
10.00 - 10.30
Networking Break
Facing the China Challenge – An Interactive
Workshop on Construction Projects in China
Quality Metrics - Part 2
End-to-End Product Risk Management
Antibody Drug Conjugates – An Opportunity and a Challenge
Drug Shortages Prevention Plan – Best Practices and Case Studies
Single-Use Technology – The Advances of a
Flexible Technology in a Structured Environment
Current Status and Trends on Serialization and
Track & Trace - Part 2
Early Access to Investigational Medicines
Innovation Forum:
Part 1 - Resisting Temptation – A Unique
Approach to Implementing New Pharmaceutical
Systems;
Part 2 - Case Study: Resolving a Legacy Product
Quality Issue through Application of Process
Understanding and Design of Experiments
CONNECT SHARE FOLLOW #ISPEAM15 www.ISPE.org/2015-Annual-Meeting 11

• Chemicals/Manufacturing/Controls
(CMC)
• Analytical Methods and Validation
• Tech Transfer, Scale Up,
Trouble-shooting
• Quality Management Systems
• Pre-Approval Preparation
& Readiness
• Acquisition/Partnering Due Diligence
• Quality Risk Management
• Commissioning & Qualification
• Compliance Remediation
• Operational Excellence
Staffed by industry experts, Pharmatech Associates provides consulting and services to the regulated life science industry. Pharmatech’s services cover four spheres of technical expertise that are necessary throughout the complete product development lifecycle: Product and Process
Development, Compliance, Regulatory, and Validation. Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area.
P: 1.510.732.0177 F: 1.510.732.1992 Toll Free: 1.877.787.0177 contact@pharmatechassociates.com | www.pharmatechassociates.com
THE
E L E G A N T

®
(T50)
Instructor: Sion Wyn, Director, Conformity Ltd
Can your data integrity process stand up to regulatory scrutiny?
Data integrity is currently one of the highest cited areas in regulatory observations, and a topic of great interest within the industry and for regulatory agencies that are re-evaluating industry guidance and their enforcement strategies. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data, and ensure the integrity and validity of information throughout the data lifecycle.
Immediately apply the course learning objectives with a complimentary bound copy of the GAMP ® 5: A Risk-Based Approach to
Compliant GxP Computerized Systems Guide and an individual download of the GAMP Good
Practice Guide: A Risk-Based Approach to
Compliant Electronic Records and Signatures .
See page 16 for Training Course registration and pricing.
14 ISPE Annual Meeting 2015
See page 16 for Training Course registration and pricing.
®
(T41)
Instructor: Stephanie Wilkins, PE, President,
PharmaConsult US
Do you need strategies to safely manufacture your high-hazard products in multiproduct facilities?
Know how to use quality risk management processes to determine the extent of technical measures required to control the risk of cross-contamination. This course outlines a method for you to prepare Quality
Risk Management plans based on ICH Q9, using health-based exposure limits to provide manufacturers with tools to reap the benefits of lower costs and higher efficiency while maintaining product quality and patient safety.
Immediately apply the course learning objectives using the complimentary copy of the ISPE Baseline Guide:
Volume 7 Risk-Based Manufacture of
Pharmaceutical Products (Risk-MaPP) .
(Individual Download)
(T43)
Do you know how to use QbD to reduce costs, improve manufacturing and meet regulatory expectations?
This interactive course uses group exercises to provide examples of how products and processes can be developed using QbD with an emphasis on the considerations for implementing these processes in manufacturing. Topics include: understanding the principles of a science- and risk-based approach; product and process understanding and patient requirements; implications of relevant ICH, EMA,
ASTM E2500, and FDA Guidelines; QRM tools (FMEA, risk ranking); applying FMEA to Control Strategy selection; the relationship between PQS and GMP and how they link to Control Strategy; considerations when implementing a control strategy derived from enhanced QbD approaches; and opportunities for continual improvement arising from application of statistical techniques.
Immediately apply the course learning objectives using the complimentary copy of the ISPE PQLI ® Guide Series:
Part 1 – Product Realization using
Quality by Design (QbD): Concepts and Principles and Part 2 – Product
Realization using Quality by Design
(QbD): Illustrative Example .
CONNECT SHARE FOLLOW #ISPEAM15 www.ISPE.org/2015-Annual-Meeting 15

(T19)
Instructor: Bruce Davis, Principal, Global Consulting
Does your technology transfer reflect an enhanced approach to current best practices?
Technology Transfer (TT) includes knowledge transfer, science and risk-based principles including ICH
Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) have become increasingly important. This course identifies criteria for successful
TT and provides ‘how to’ examples which can be individually tailored depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry professionals and regulators to use when conducting and evaluating TT activities.
Immediately apply the course learning objectives using the complimentary copy of the ISPE Good Practice Guide:
Technology Transfer (Second Edition) .
TYPE
ON OR BEFORE
11 OCTOBER
AFTER
11 OCTOBER
Member US $ 1,800 US $ 2,000
Registration +
Membership*
Nonmember
Government
US $ 2,079
US $ 2,186
US $ 900
US $ 2,279
US $ 2,396
US $ 900
®
TYPE
ON OR BEFORE
11 OCTOBER
AFTER
11 OCTOBER
Member US $ 1,700 US $ 1,900
Registration +
Membership*
Nonmember
Government
US $ 1,979
US $ 2,081
US $ 850
US $ 2,179
US $ 2,291
US $ 850
*Fee includes one-year ISPE membership.
Training course registration includes course materials, break and lunches. Hotel accommodations, hotel fees and a la carte events are separate from registration fees. Registration is confirmed only when payment is received. Annual Meeting registration does not include training courses.
16 ISPE Annual Meeting 2015
1201 Market Street
Philadelphia, PA 19107
Tel: +1-215-625-2900
Check-in: 16.00
Check-out: 12.00
ISPE rate: US$249 single/double
Once you have registered for the event online, you will see your personal reservation link on the order detail page to make your hotel reservation. Your registration confirmation letter will also have your reservation link.
Be sure to make your hotel reservation immediately to ensure a room at the Marriott. Changes can be made online by following the directions in your hotel acknowledgment email.
On 14 October, ISPE will transfer the reservations to the hotel. Rest assured your room is reserved once you make your reservation through ISPE. The hotel will send out confirmations by email after 14 October.
A deposit of one night is required to hold your room reservation and is nonrefundable after
14 October. Credit cards will be charged one night as of 15 October. Please complete the credit card information in full to have a guaranteed reservation.
Guests canceling their stay less than 72 hours prior to the day of check-in will be charged for their full stay.
Please note that if you do not arrive on the first day of your room reservation, the hotel will charge you a no-show fee equal to one night and may not have a hotel room available when you arrive. Please remember to contact the hotel if you are delayed.
After you have made your hotel reservation through ISPE, you can contact Althea Morgan
(Althea.Morgan@Marriott.com) to ask about room upgrade options.
• Complimentary in-room Internet for ISPE attendees
• 25% discount on overnight valet parking
• 24-hour access to fitness center
Philadelphia International Airport
10 mi /16 km to hotel
CONNECT SHARE FOLLOW #ISPEAM15 www.ISPE.org/2015-Annual-Meeting 17

SUNDAY, 8 NOVEMBER 2015
17.00 – 19.00
Exhibit Hall, Philadelphia Marriott Downtown
US$50 (Included with Full Registration Only)
Sponsored by: delivering excellence
MONDAY, 9 NOVEMBER 2015
06.30 (Start time 07.00)
Buses depart at 06.30 from hotel lobby
US$25
Start the day with a run/walk by scenic Boathouse
Row along the Schuylkill River. Proceeds benefit the
Center for Information & Study on Clinical Research
Participation (CISCRP).
Sponsored by:
MONDAY, 9 NOVEMBER
07.15 – 08.15
Philadelphia Marriott Downtown
For new ISPE Members and First-Time Annual
Meeting attendees only (Included in Full and
Monday-Only Registrations)
New to ISPE? Is this your first ISPE Annual Meeting?
Find out how to make the most of your Annual Meeting experience and ISPE membership while you enjoy a continental breakfast. Bring your business cards. You’ll quickly build your lifelong professional network with one of our most popular events: Speed Networking.
MONDAY, 9 NOVEMBER 2015
19.30 – 22.00
Lucky Strike
US$58
Get ready for a fun networking event that can bring out your competitive spirit. Bowling, shoes, food and soft drinks are included. Hosted by ISPE’s Young
Professionals. (Cash bar)
18 ISPE Annual Meeting 2015
TUESDAY, 10 NOVEMBER 2015
08.00 – 10.00
US$45 (Included in Full and Tuesday-Only
Registrations)
Join ISPE leadership and colleagues for breakfast as we look back on 2015 and recognize significant achievements.
Celebrate with your colleagues as the
2015 Facility of the Year (FOYA) Overall
Winner and ISPE International Honor
Awards are presented.
Sponsored by:
TUESDAY, 10 NOVEMBER 2015
19.00 – 22.00
(Meet in the lobby by 18.45 to network and walk over to the party with the Mummers)
Reading Terminal Market
US$200 (Included with Full Registration Only)
Experience a Taste of the Terminal with a wide variety of delicious cuisines and Philadelphia favorites on the menu! Reading Terminal is a 123-year-old historic building located in the heart of Philadelphia. On the list of Top 10 places to visit in America, Reading
Terminal hosts mouth-watering aromas, locally grown and exotic produce, fresh meats, seafood and poultry, baked goods straight from the oven, AND the widest variety of restaurants under one roof! The night will be full of networking, entertainment by the famous Philadelphia Mummers—and for the first time, get ready to rock with an ISPE Member band.
Sponsored by:
WEDNESDAY, 11 NOVEMBER 2015
Includes: transportation, tours and lunch
All tours depart from Philadelphia Marriott Downtown.
Register early. Space is limited. See more details on the website.
Tour I
Merck’s Gardasil Vaccine
Production Facility
10.00 – 16.00
$50
• Tour Independence Hall
• Tour Merck’s Gardasil Vaccine Production Facility
• Lunch (included)
• Tour of Valley Forge
Tour II
Morphotek’s 2013
Sustainability Facility of the Year Category Winner
09.40 – 20.00
$85
• Tour Independence Hall
• Tour Morphotek’s Sustainable Facility of the Year
• Lunch (included)
• Tour Longwood Gardens
• Dinner at Victory Brewery (included)
Tour III
AstraZeneca’s Newark Facility
Transformation Project
09.00 – 20.00
$85
• Tour Independence Hall
• Tour AstraZeneca’s New Formulation Suite
• Lunch (included)
• Tour Longwood Gardens
• Dinner at Victory Brewery (included)
Sponsored by:
CONNECT SHARE FOLLOW #ISPEAM15
Independence Hall Tour Longwood Gardens Tour and Dinner
Merck Tour Bus Sponsor AstraZeneca Tour Bus Sponsor www.ISPE.org/2015-Annual-Meeting 19

1 Via Online: Register online www.ISPE.org/2015-Annual-Meeting/Register
2 Via Email: Complete the registration form, scan and email it to ask@ispe.org
3 Via Fax:
4 Via Mail:
Complete the registration form and fax it to +1-813-264-2816
Complete the registration form and mail it with payment to:
ISPE Headquarters
600 N. Westshore Blvd., Suite 900, Tampa, Florida 33609 USA
TYPE
ON OR BEFORE
11 OCTOBER
Member US $ 1,950
Registration +
Membership*
Nonmember
Committee
Government
Young Professional
Member
US $ 2,230
US $ 2,330
US $ 1,465
US $ 700
US $ 1,465
Student Member US $ 200
Academia Member US $ 1,465
*Includes a 1-year membership to ISPE.
AFTER
11 OCTOBER
US $ 2,150
US $ 2,430
US $ 2,530
US $ 1,615
US $ 700
US $ 1,615
US $ 200
US $ 1,615
TYPE
ON OR BEFORE
11 OCTOBER
AFTER
11 OCTOBER
Member US $ 749 US $ 849
Nonmember US $ 949 US $ 1,099
Bring your team to ISPE Annual
Meeting
3 - 5 participants Save 10%
6 -10 participants Save 15%
11 or more participants Save 20%
To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will
NOT be eligible for the group discount. To register as a group, please contact ISPE (tel: +1-813-960-2105).
Cancellations must be made in writing. If cancellations are received by 18 October 2015, a full refund, minus a $100 handling fee, will be issued. After that time, no refunds will be granted. If you are unable to attend, substitutions will be accepted. However, nonmembers substituting for a Member must pay the difference in fees prior to the start of the event.
ISPE is not responsible for lost airfare due to cancellations.
If you are unable to attend, substitutions will be accepted and will result in a $25 per person change fee. Payment for the change fee is due at the time the change is requested and is non-refundable.
20 ISPE Annual Meeting 2015
Find your next amazing job opportunity or your next great employee using ISPE Career Solutions. Visit the Career Solutions Hot Jobs booth to review current job postings and learn about the benefits of posting your open positions on ISPE’s online job board.
Show pride in your local
Affiliate or Chapter. Pick up your Affiliate or Chapter badge ribbon at the ISPE
Membership display.
ISPE — Membership Has Its Benefits
Did you know that Members get big savings on all of ISPE’s training programs and events? A “Registration + Membership” bundled registration fee includes a one-year ISPE Membership.
Visit www.ISPE.org/Membership for details on benefits as well as discounted dues rates for Young Professionals, Students, Academics,
Regulators and industry professionals from emerging economies.
CONNECT SHARE FOLLOW #ISPEAM15 www.ISPE.org/2015-Annual-Meeting 21

PINNACLE SPONSOR
Badge Sponsor
Independence Hall Tour Sponsor
PINNACLE SPONSOR
Keynote Speaker Sponsor
Lanyard Sponsor
Wireless Internet Sponsor
PINNACLE SPONSOR
Leadership Reception Sponsor
Tote Bag Insert Sponsor
Host Sponsor Supporting Sponsor Gold Sponsor
Leadership Reception Sponsor
Silver Sponsor
FOYA Marquee Sponsor
Tuesday Night Party Sponsor
Silver Sponsor
Exhibit Hall Giveaway Sponsor
Silver Sponsor
Exhibit Hall Giveaway Sponsor
Membership Breakfast Sponsor
22 ISPE Annual Meeting 2015
Refreshment Sponsor Charity 5k Walk/Run
Sponsor
Exhibit Hall Giveaway
Sponsor
Lunch Sponsor
Lunch Sponsor Exhibit Hall Giveaway
Sponsor
Membership Breakfast Sponsor
Welcome Reception Sponsor
Longwood Gardens Tour and Dinner Sponsor
AstraZeneca Tour Bus
Sponsor
Hotel Key Card Sponsor Exhibit Hall Giveaway
Sponsor
Merck Tour Bus Sponsor
Exhibit Hall Giveaway
Sponsor
Tuesday Night Party Prize
Sponsor
Exhibit Hall Giveaway
Sponsor
Poster Competition Sponsor
Tote Bag Sponsor delivering excellence
Welcome Reception
Sponsor
Exhibit Hall Giveaway
Sponsor
Exhibit Hall Giveaway
Sponsor
Exhibit Hall Giveaway Sponsor
CONNECT SHARE FOLLOW #ISPEAM15
Membership Breakfast Sponsor www.ISPE.org/2015-Annual-Meeting 23

ISPE Global Headquarters
600 N. Westshore Blvd., Suite 900
Tampa, Florida 33609-1114 USA
Group Discount Available
See page 20 for more information
3 - 5 participants Save 10%
6 -10 participants Save 15%
11 or more participants Save 20%
www.facebook.com/ISPEorg
#ISPEAM15 http://bit.ly/ISPELinkedIn http://blog.ISPE.org/