Presents

Current Challenges Topics in CTM
(Clinical Trial Materials)

November 12-13, 2008
Woodbridge Hotel & Conference Center– Iselin, NJ

Current Challenges Topics in CTM (Clinical Trial Materials) is a two-day intensive and practical program focusing on effective management of Clinical Trial Materials.

COURSE DESCRIPTION AND OBJECTIVES

Our goal is to provide an intensive, practical program focusing on selected current challenges topics in the management of the CTM process for more experienced personnel. Application of these topics will be achieved through presentations, workshops, case studies, life experiences, and lively interaction between participants and instructors.

Additionally, at the conclusion of the course, each participant will be able to:

1. Attendee will be able to summarize FDA’s current quality expectations for clinical trial materials
2. Attendee will be able to compare and contrast former regulatory quality expectations versus current quality expectations
3. Attendee will be able to identify key elements of clinical supplies project management
4. Attendee will be able to list tools available for automating CTM project management
5. Attendee will be able to give examples of clinical supply chain automation programs and list change management considerations when implementing them
6. Attendee will be able to summarize the impact of culture on producing and distributing clinical supplies globally
7. Attendee will be able to extend the lean principals to clinical supply chain processes
8. Attendee will be able to explain CTM outsourcing challenges while differentiating them between the CRO and sponsor viewpoints.

COURSE CONTENTS

WHO SHOULD ATTEND

Our Current Challenges Topics in CTM training program is designed for:

INSTRUCTORS

Co-Director: Steve Jacobs

Steve Jacobs, MBA, RPh, is the President of Global BioPharm Solutions, LLC. Prior to this, he was President of Bilcare Pharma Packaging Research in Phoenixville, PA. He has also held key positions at J&J Pharmaceutical research and Development, McNeil Consumer Healthcare, and Otsuka America in the area of Clinical Supplies

FEE

FEE: ……..$1400 (U.S.)
Fee includes tuition, course notes, continental breakfasts, lunches, and morning and afternoon breaks. Please note this fee does not include hotel accommodations, travel costs, and evening meals.

Discounted fee of $1350 each for three or more enrollments from the same company

Payment is required no later than 10 business days prior to the training course.
You may pay by check, money order or credit card.

Please make payable to Pharmaceutical Training Seminars, Inc.

WOODBRIDGE Hotel & Conference Center – ISELIN, NJ
 

Registration will begin at 7:30 a.m. on Wednesday. The program commences at 8:00 a.m. each day, and concludes at 4:30 p.m.

Dress is business casual.

Applicants may cancel up to fifteen business days prior to the start of the course to receive a full refund. Substitutions may be made at any time prior to the start of the course.

COMMENTS FROM PAST PARTICIPANTS

“Great class! Very informative, interactive, useful and pertinent to the industry.”
           Brian Parks, ClinTrak

“This was a very refreshing course that cleared up a couple of misconceptions that I had. I'll be able to take back some very valuable information to my office.”
           Cathy Miller, MedImmune, Inc.

“The speakers make the course subject more interesting and are very knowledgeable in their field.”
           Daniel Sacher, Cephalon, Inc.

COURSES AT YOUR LOCATION

Our program can be customized and conducted at your company location. In-house programs provide the added benefit of educating many employees simultaneously and customizing the program to your company-specific needs. Please contact Karla Vasquez at (908) 233-4508 for more information.

REGISTRATION FORM

PHARMACEUTICAL TRAINING SEMINARS, INC.
(A Division of Jeiven Pharmaceutical Consulting, Inc.)

Register Via Fax // Register Via Online Form

If faxing, fax the registration form to Tracy Bodziony at (908) 654-4829
Send check (payable to PTS) to:

Tracy Bodziony, Manager of Training Programs
Pharmaceutical Training Seminars, Inc.
6 Jacobs Lane
Scotch Plains, NJ 07076

PHARMACEUTICAL TRAINING SEMINARS, INC
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