Register by October 9, 2009 and Save up to $200!

OctOber 26-27, 2009Hyatt regency bOstOnbOstOn, Ma

Barnett International/ Cambridge Healthtech Institute’s Inaugural

Coverage Includes:• Driving Training Initiatives:

Current Regulatory Environment Considerations

• Designing Clinical Research Training for Global and Remote Teams

• Clinical Training Program Development

• Site Training Considerations

• Learning Methods, Training Techniques, and Best Practices

• Investigator Meeting Training Initiatives

• And much more!

Cambridge Healthtech Institute250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5400 • Fax: 781-972-5425 Toll-free in the U.S. 888-999-6288 www.barnettinternational.com/ctr

CLINICALTRAINING

Lorie Azia, Senior Manager, Technical Training, Biogen Idec

Rhea Bagnell, Manager, Operational Performance Strategies, Pfizer Global Research and Development

Carola Beier, Global Training Manager, Process & Capability Improvement/Clinical Information and Learning Management, EMD Serono

Eileen Caramanica, Clinical Project Manager, Global Clinical Trial Management, Schering-Plough

Megan Domenico, MBA, RN, Clinical Manager, Clinical Research Unit, Children’s Memorial Hospital, Chicago

Denise Finley, Director - Clinical Learning and Development, Boston Scientific

Joanne Godman, Director, Clinical Training & Communications, Clinical Operations, Shire Pharmaceuticals

Sheila Gwizdak, Director, Development Operations, Pfizer, Inc.

Gerlinde Jayme, Head, Learning, Management, Process & Capability Improvement/Clinical Information and Learning Management, EMD Serono

Lisa Joseph, Associate Director, R&D Training, Biogen Idec

Melissa Kadar, Research Manager, Center for Clinical Research, Cleveland Clinic

Maria Mancini, Principal Associate, Cardiovascular Clinical Research, Genzyme

Randi Misnik, BS, Senior Clinical Operations Manager, Teva NeurosciencesBertha Robbins, RNC, MS, CCRP, Clinical Research Manager for the Clinical Trials Unit, Connecticut Children’s Medical CenterBarbara van der Schalie, Clinical Training Manager, Clinical Monitoring Research Organization, SAIC-Frederick, Inc., National Cancer Institute at FrederickGregg Van Citters, Ph.D., Senior Clinical Research Training Specialist, Medtronic Diabetes, Inc.Diana Yadgir, Training Manager, GenentechLori Vivian, RN, BSN, CCRP, Clinical Research Manager II, Vascular Surgery Academic Coordinating Center, Cleveland Clinic

FORUM 2009

Final Brochure

The Premier Event for

Clinical Training Professionals

Distinguished Faculty:

gain insight into delivering a training program for a global audience. They will learn how to use technology to maximize their resources. The audience will also be able to see that this program has had a direct impact on the quality of Pfizer’s clinical studies.

10:15 Coffee Break and Exhibit Viewing

10:30 Approaches to GCP Training: Best Practices and Lessons Learned from Industry ExpertsSharon Fernandes, Shire PharmaceuticalsGood Clinical Practices are a critical success factor to ensuring regulatory compliance while conducting clinical trials in a global environment. Not only are pharmaceutical companies responsible for ensuring internal GCP training of their clinical colleagues, but they are accountable for the training of their external partners. This presentation will share best practices used at Shire to ensure that colleagues and partners have been trained via various learning methods, and how the learning can be accounted for during a regulatory inspection.

12:15 Luncheon

CLINICAL TRAINING PROGRAM DEVELOPMENT

1:30 Utilizing Competency Based Training for a Global Clinical and Global Manufacturing Operations OrganizationLisa Joseph, Associate Director, R&D Training, Biogen IdecLorie Azia, Senior Manager, Technical Training, Biogen IdecIn late 2007, Biogen Idec embarked on a clinical quality improvement program, one aspect of which was the development of a more robust clinical training program. In parallel, the global manufacturing group also embarked on a similar program. Each functional area within Global Clinical Operations and Global Manufacturing designed “competencies” or topics that were relevant to their area based on job profiles, current requirements, and main roles and responsibilities of their function. The focus stayed on task or knowledge based competencies (“hard skills”). This presentation will give an overview of the plans and tools used from planning through initial implementation, as well

MONDAy, OCTObER 26, 2009

DRIVING TRAINING INITIATIVES: CURRENT REGULATORy ENVIRONMENT CONSIDERATIONS

8:00 Registration and Morning Coffee

8:15 Barnett Welcome and Opening Remarks: Maximizing Training in the Current Regulatory Environment: Turning Risk into OpportunityNaila Ganatra, General Manager, Barnett International

8:25 General Information and Introduction of ChairpersonRachel Meyers, Associate Director, Barnett International

8:30 Chairperson’s Opening Remarks8:45 Why Train? What the FDA Warning Letters Tell Us

Barbara van der Schalie, Clinical Training Manager, Clinical Monitoring Research Organization, SAIC-Frederick, Inc., National Cancer Institute at FrederickWhile the Good Clinical Practices (GCPs) do not clearly mandate

specific training requirements, a review of the FDA Warning Letters over the past several years indicate increased scrutiny of the qualifications of clinical research staff. This presentation will provide an overview of the clinical research-associated FDA Warning Letters and associated trends. While training is not the primary focus of FDA Warning Letters, the number of training-specific citations in FDA Warning Letters has increased significantly over the last 3 years. This is significant, since the GCPs do not specifically mandate training requirements, as the other GXPs do. The audience will learn not only the general trends in compliance indicated by the citations, but also a systematic approach to evaluate their training program for thoroughness and quality.

DESIGINING CLINICAL RESEARCH TRAINING FOR GLObAL AND REMOTE TEAMS: bEST PRACTICES

AND LESSONS LEARNED FROM THE FIELD

9:30 Successfully Training Global and Remote Clinical Research Teams…It’s a Virtual World!Kathy Donato, Senior Training Manager, Johnson & Johnson Pharmaceutical R&DTraining a global CRA workforce of both internal and outsource staff is a huge financial and logistical challenge for every pharmaceutical company. This presentation will describe how Pfizer approached their CRA training program in a multi-pronged approach that utilized technology in order to maximize use of resources. This approach has not only been successful in training the global CRA workforce but has increased the quality of monitoring. The audience will

www.barnettinternational.com/ctr Cambridge Healthtech Institute250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5400 • Fax: 781-972-5425 Toll-free in the U.S. 888-999-6288

Barnett International/CHI’s Clinical Training Forum features best practice case studies, lessons learned, and presentations focused on the challenges associated with role-based training in the clinical research environment. Included are key regulatory considerations and findings, as well examples of how training deficiencies can put clinical research activities at risk. Leading industry training professionals will share their approaches to managing training challenges, as well as how they leverage resources across their companies to optimize training and compliance. Attendees will have multiple opportunities to interact with conference faculty, engage with each other on lessons learned in the field, and benchmark their training initiatives against industry best practices.

11:15 Roundtable Session #1: Effectively Training Global and Remote/Field-Based Teams: Best Practices from the Field

As we move from classroom-based training to training remote and global teams, new challenges come into play. In this interactive session, attendees will participate in discussions about what has worked, what has not, and how we can move away from making training initiatives a “box-checking” exercise.

Conference Overview

as challenges and opportunities along the way. This presentation will give an overview of one company’s implementation of such a system for two diverse organizations, and perhaps encourage others down the same beneficial path.

2:10 Even GCP Training Can Be Interesting: Making Clinical Training More Interactive and Effective

Eileen Caramanica, Clinical Project Manager, Global Clinical Trial Management, Schering-PloughTraining doesn’t have to be boring! Add interactivity and enjoyment to your training with techniques that will increase your effectiveness

as a trainer. By learning adult learning methodologies imbedded throughout this session, you can engage your audience and have them better retain your information. Several techniques (including a skit) will be demonstrated - don’t be surprised if you’re interactive in this session! Attendees will learn how to conduct more interactive clinical training, make clinical training more interesting and enjoyable, and most importantly, make clinical training more effective ensuring your audience retains more.

3:30 Break

3:45 Partnering Effectively with Subject Matter Experts (SMEs) for Optimal Training Collaboration

Diana Yadgir, Mgr Functional Excellence, gRED Clinical Operations, Genentech, Inc.As an advocate for the learner, a primary goal of the training professional is to help people realize their potential through learning

events. However, research has shown that poorly designed or delivered training can actually leave the learner less informed. In addition, any learning that does not work is expensive. Most training development involves working with Subject Matter Experts (SMEs). With effective collaboration and appropriate coaching by training professionals, SMEs can learn to more efficiently provide their valuable expertise for training material content and also effectively assist with the facilitation of instructor-led training.

3:30 Refreshment Break and Exhibit Viewing

5:15 Close of Day One

TUESDAy, OCTObER 27, 2009

7:45 Morning Coffee

8:00 Chairperson’s Day Two Welcome

SITE TRAINING CONSIDERATIONS

.

8:45 Strategies for Proactively Promoting Site-Focused Training

Lori Vivian, RN, BSN, CCRP, Clinical Research Manager II, Vascular Surgery Academic Coordinating Center, Cleveland Clinic Site training can be a very difficult undertaking, due to their varied

availability and learning styles. In this session, we will explore an effective strategy for multi-center site training. The Cleveland Clinic approach is multifaceted in that site training is provided at several times in several different formats to accommodate each study coordinator and PI’s busy schedule and their most effective learning style. This approach evolved over the course of one of our seven-year studies. We found that many more sites were trained in a shorter amount of time when we did the training using this multifaceted approach. Depending on the depth of training (initial protocol training or an amendment training), we use lecture, interactive methods, and everything in between, including recorded lecture for a more independent training.

9:30 Case Study: Strategies for Proactively Promoting Site-Focused Training

Denise Finley, Director - Clinical Learning and Development, Boston Scientific The application of best practices in accordance with Good Clinical Practice to manage investigational sites is critical to the success of

a clinical trial. Sponsor personnel need to be adequately trained to respond to real life situations in a timely manner. In order to better prepare sponsor personnel to effectively manage investigational sites, an eLearning program entitled “Situational Good Clinical Practice” was developed at Boston Scientific. During this presentation, we will present the details of Boston Scientific’s scenario-based eLearning course, which requires the learner to correctly choose the best practice for multiple challenges by reviewing a situation, viewing conversations between site personnel, and reviewing essential documents and medical records. The presentation will cover the overall approach, the learning mechanics involved, as well as how the learner solves the challenge and progresses to the next step.

10:15 Coffee Break and Exhibit Viewing

10:30 Linking Master to Novice: Mentoring Clinical Research Professionals

Megan Domenico, MBA, RN, Clinical Manager, Clinical Research Unit, Children’s Memorial Hospital, ChicagoIn many different settings, mentoring has shown to develop quality employees, facilitate the sharing of knowledge and ideas, and

empower staff to excel in their careers. Most academic institutions operate clinical research in “silos” divided by medical specialty, resulting in small research teams limiting knowledge and experience to only that group. In some cases, these groups contain one or only a few research coordinators and as staff turns over much, if not all, of the knowledge and experience is lost. The difference between a quality, experienced coordinator and a poorly trained or novice coordinator could translate to regulatory compliance issues, breach of human subject protection, inadequate budget management, and recruitment losses. Establishing a mentoring program that links expert coordinators with novice coordinators is critical to quality clinical research, as well as a mutually beneficial arrangement between the two coordinators. Audience members will gain knowledge on the structure and function of a mentoring program. In addition, they will understand the financial detriment of time lost as new coordinators “learn the ropes” on their own, and the potential cost of mistakes made along the way.

11:15 Maximizing Training Content and Resources across Clinical Research Job Functions

www.barnettinternational.com/ctr Cambridge Healthtech Institute250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5400 • Fax: 781-972-5425 Toll-free in the U.S. 888-999-6288

4:25 Roundtable Session #2 (choose one):

A) Defining Clinical Training Department Responsibilities: Creating Stakeholder Accountability

B) Employing Social Media in Training Initiatives: Twitter, Pod-casts, Wikipedia, Social Networks, and YouTube

C) Strategies for Maximizing Training Resources in Small- to Mid-sized Companies

D) Regulatory Perspectives on Compliance Training: Current Climate Considerations

Bertha Robbins, RNC, MS, CCRP, Clinical Research Manager for the Clinical Trials Unit, Connecticut Children’s Medical Center In the current economic climate, the ability to conduct research at

institutions has been under closer scrutiny. A successful research program must encompass a system of collaboration for education, regulatory, monitoring, operations functions, human subject protections, patient safety, quality improvement, fiscal management, and research compliance. A coordinated program that successfully oversees these activities provides the best utilization of scarce resources and maximizes clinical research personnel as clinical research waxes and wanes. Centralization of personnel and services assures that all clinical research for each study is conducted under the same high standards. This allows for all clinical research personnel to have available mentors to collaborate with to provide safe and ethical conduct of research at the institution. One important aspect of such a program is to have a formalized orientation program for new personnel that encompass all the functions that are specific to clinical research. Once such a program is put into place, coverage for research studies can be shifted quickly as new studies are opened and others are completed. This also allows for coverage for vacations and off hours without sacrificing safety and quality. This collaboration encourages clinical research personnel to both support and learn from each other, enhancing job satisfaction.

12:00 Luncheon (on your own)

LEARNING METHODS, TRANING TECHNIQUES, AND bEST PRACTICES

1:30 Applying an Activating Learning Approach to ICH GCP Training

Gerlinde Jayme, Head Learning Management, Process & Capability Improvement/Clinical Information and Learning Management, EMD Serono

Carola Beier, Global Training Manager, Process & Capability Improvement/Clinical Information and Learning Management, EMD SeronoThis session will provide an overview of the overall (blended) training

concept for ICH GCP training at EMD Serono , as well as strategies for a creative training design that is tailored to the training needs of various groups within Clinical Research. The audience will learn how to integrate the “fun” factor to a topic normally considered to be very theoretical and “dry.” Examples of activities and exercises used in compliance training with high impact interaction for guaranteed learning transfer. Presenters will introduce a state-of-the-art activating learning approach to ICH GCP training that has been very successful in the past two years at EMD Serono .

2:15 Learning Styles and Learner Adaptability: Impact on Clinical Training Design

Gregg Van Citters, Ph.D., Sr. Clinical Research Training Specialist, Medtronic Diabetes, Inc.Clinical research operations require a detail orientation for successful compliance. Paradoxically, clinical research by nature requires

diametrically opposed skills to cope with the constantly changing clinical, regulatory, and business environment. Effective training across the spectrum requires adaptability on the part of the trainer and the learners to ensure transfer of knowledge, skills, and influencing attitudes. We will explore training and learning styles and the adaptability of each in a clinical human performance environment. The desired outcome of any training in the clinical research environment is to effectively influence human performance. Trainers may not be aware of their own training styles or the need to adapt to the situation and the learner. Simple tools and awareness of the issues surrounding training and learning styles can make learning more effective to achieve sustained performance. Attendees will walk away with an appreciation of dominant training and learning styles, and how to adapt them to any training/learning situation.

3:00 Refreshment Break and Exhibit Viewing

www.barnettinternational.com/ctr Cambridge Healthtech Institute250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5400 • Fax: 781-972-5425 Toll-free in the U.S. 888-999-6288

INVESTIGATOR MEETING TRAINING INITIATIVES

Results of each roundtable will be compiled and shared with all groups at the end of the session.

4:00 Investigator Training: Making the Investigator Meeting Work for You

Maria C. Mancini, MHP, RAC, Principal Associate, Cardiovascular Clinical Research, Genzyme Nowadays, conducting a clinical study is more complicated than ever. Increasingly complex protocols, new technologies, and increased

regulatory scrutiny have all made study implementation more challenging. Considering that sites may be participating in several studies at any given time, often with different sponsors, it becomes apparent that there is a lot of room for error on the site’s part. How should a Sponsor support their sites for this large undertaking? Traditionally, the Sponsor will hold an investigator meeting where several hundred doctors and study coordinators assemble in a central location in order to soak up the protocol details, ask questions, and otherwise prepare themselves for participating in the upcoming study. This is an age-old practice, but is it still viable? Are the doctors and study coordinators taking information away from the meeting? Do steps need to be taken to provide training that is not only more effective but delivered in a more efficient manner as well? This session will review the typical characteristics identified at an investigator meeting, evaluate what aspects are capable of being changed or updated to reflect current thinking and technology, and come up with a model for the next generation investigator meeting.

4:45 Industry Standardization of GCP Investigator TrainingDr. Felipe Fregni, Assistant Professor in Neurology, Harvard Medical School

Before being considered competent to manage a clinical trial, Investigator GCP training is a basic requirement, therefore all pharmaceutical companies have similar needs for GCP training. This presentation will focus on why it makes sense for companies managing clinical trials to leverage collaboration regarding GCP training and create a standard, benchmarked curriculum. The benefits to industry would be to (1) standardize GCP knowledge, (2) reduce training costs, and (3) increase study quality. Additionally, by standardizing how clinical trial investigators are educated, trained, and evaluated against the regulations and standards, regulatory compliance becomes more transparent.

5:30 Chairperson’s Closing Remarks

5:45 Close of Conference

Cambridge Healthtech Institute250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5400 • Fax: 781-972-5425 Toll-free in the U.S. 888-999-6288

3:15 Roundtable Session #3:

Training Techniques Toolbox: Best Practices from “Expert” Trainers

In this interactive session, attendees will break into roundtable sessions facilitated by seasoned trainers to share techniques, best practices, and pitfalls to avoid around the following issues:

Developing and Delivering Interactive Exercises That Work•

Strategies and Baseline Considerations When Training English •Language Learners

Dealing with the “Quiet” Audience: Tools for Generating •Discussion and Interaction

Turning Subject Matter Experts into Successful Trainers: •Strategies and Tools

Making Web-Based Training Engaging and Interactive•

For Questions About the Meeting, Please Contact:

Naila Ganatra, General Manager, Barnett International(215) 413-2471 or nganatra@barnettinternational.com

Rachel Meyers, Associate Director, Barnett International(413) 527-3056 or rmeyers@barnettinternational.com

Hotel & Travel Information

Conference Hotel:

Hyatt Regency BostonOne Avenue de LafayetteBoston, MA 02111Phone: 617-912-1234 • Fax: 617-451-2198

Room Rate: $249 s/dReservation Cut-off: October 1, 2009

To reserve your hotel room, call the hotel directly to make your room reservation. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.

Flight Discounts:To receive a 5% or greater discount on all American Airline flights, please use one of the following methods:

l Call 1-800-433-1790 (authorization code A4819SS).

l Go online at www.aa.com (enter A4819SS in Promotion discount box).

l Contact Wendy Levine, Great International Travel 1-800-336-5248 ext. 137.

Car Rental Discounts:Special discount rentals have been established with AVIS for this conference. Please call AVIS directly at 800-331-1600 and reference our Avis Worldwide Discount (AWD) Number J868190.

Sponsorship Information

BECOME A SPONSOR

Your company has a unique opportunity to influence this major gathering of Clinical Training leaders attending Barnett’s Clinical Training Forum.

Brand your company as a thought leader in managing training challenges by participating as an active Sponsor. Presenting your solutions or services directly to our delegates can significantly impact their purchasing and collaboration decisions and help you achieve your sales and business development objectives.

Opportunities include an Agenda, Breakfast or Luncheon Presentation, or you may pre-select and gain access to your highest level prospects through an Invitation-only VIP Dinner or function (limited availability).

CHI will support your Sponsorship and brand your Company with strong marketing programs before, during and after the event. The earlier you secure your Sponsorship, the more opportunity for exposure.

To discuss your objectives and participation options, please contact: Arnie WolfsonManager of Business DevelopmentPhone: 781-972-5431E-mail: awolfson@healthtech.com

www.barnettinternational.com/ctr

CHI Insight Pharma ReportsA series of diverse reports designed to keep life science professionals informed of the salient trends in pharmaceutical technology, business, clinical development, and therapeutic disease markets. For a detailed list of reports, visit InsightPharmaReports.com, or contact Rose LaRaia, rlaraia@healthtech.com, 781-972-5444.

Barnett Educational ServicesBarnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit www.barnettinternational.com.

Additional Registration DetailsEach registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link.

Group DiscountsSpecial rates are available for multiple attendees from the same organization. Contact David Cunningham at 781-972-5472 to discuss your options and take advantage of the savings.

Handicapped Equal AccessIn accordance with the ADA, Cambridge Health-tech Institute is pleased to arrange special accom-modations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.

Substitution/Cancellation PolicyIn the event that you need to cancel a registration, you may:

Transfer your registration to a colleague within •your organization. Credit your registration to an-other Cambridge Healthtech Institute program.Request a refund minus a $100 processing fee •per conference.Request a refund minus the cost ($350 of •ordering a copy of the CD .

NOTE: Cancellations will only be accepted up to two weeks prior to the conference.Program and speakers are subject to change.

Video and or audio recording of any kind is prohib-ited onsite at all CHI events.

Please refer to the Registration Code below:

Mail Registration to: Cambridge Healthtech Institute

250 First Avenue, Suite 300, Needham, MA 02494T: 781.972.5400 l Toll-free in the U.S. 888.999.6288F: 781.972.5425 l www.healthtech.com

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MAIN CONFERENCE PRICING Academic, Government, Commercial Hospital-affiliated

Early Registration Deadline until August 21, 2009 o $1245 o $625

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*REGISTER 3 - 4th IS FREE Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply. Please reproduce this registration form as needed.

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Barnett International/Cambridge Healthtech Institute’s

OctOber 26-27, 2009Hyatt regency DOwntOwnbOstOn, Ma

CLINICALTRAINING

FORUM 2009

Visit our website for additional Barnett Training Guides and Services: www.barnettinternational.comFeatured products include:

Good Clinical Practices: A Question and Answer Reference Guide 2009

2009 CFR ICH GCPReference Guide

Glossary and Acronymsfor Clinical ResearchProfessionals