Presents
Clinical Supplies Accountability, Retains, Returns, and Destruction (ARRD):
Everything You Ever Wanted to Know But Were Afraid to Ask!
TBA
Sheraton at Woodbridge Place - Iselin, NJ
ARRD is an intensive, one-day program designed to educate course
participants in all aspects of drug accountability, retains, returns, and
destruction to meet FDA and DEA requirements. Learn how, through communication
and the proper forms and procedures, CTM industry professionals and CRO/CRAs can
work together to achieve drug reconciliations that are "painless" for all
parties concerned.
COURSE DESCRIPTION AND
OBJECTIVES
Our goal is to provide a practical program focusing on the "tools" and
processes required to successfully account for all clinical trial material (CTM)
for new drug studies. Application of fundamental concepts will be achieved
through presentations, workshops, case studies, life experiences, and lively
interaction between instructors and participants. Each participant will leave
the program with a better understanding of their role, and where they fit into
the CTM process and the Clinical Team.
Additionally, at the conclusion of the course, each participant will be able
to:
- Execute and manage all aspects of returns and destruction of CTM
- Explain why return drug accountability is important to the results of a
clinical trial and to FDA
- Develop a written procedure that includes the key "ingredients" to ensure
proper accountability of drug returns
- Explain the importance, appropriate amounts and examination of retains
- Successfully complete a DEA Form 222 for the return of controlled substances
1) Accountability |
| |
 Why
do we account for supplies?
|
| |
What
goes out, must come back (in some form) |
2) Details, Details: Accountability at the Clinical Site |
| |
What
accountability is and who’s responsible for it |
| |
What
needs to be done before a sponsor ships CTM to a site |
| |
The
role of the clinical trial monitor |
3) Return and Accountability of CTM |
| |
When
to get into the "returns" mode |
| |
Creating
return forms and procedures |
| |
Providing
the "tools" needed to return CTM |
| |
The
return has arrived! What’s in the box? |
4) Return of DEA Controlled Substances |
| |
Anticipating
the return of Controlled Drug Substances (CDS) |
| |
Defining
the project’s return drug process flow |
| |
Coordination
between sponsor, clinical sites and contractor |
| |
Documenting
the transfer of goods |
| |
Receipt,
storage and accountability of CDS |
| |
Destruction
of CDS |
5) Reserve (=Retains) Samples |
| |
Why
are retains important to the FDA? |
| |
Why
should retains be important to you? |
| |
Reserve
sample examination program |
6) Re-Use of Returned CTM |
| |
The
essential controls that must be in place |
| |
If
and when to re-use. Never say never! |
7) Destruction of CTM |
| |
Destruction
certification |
| |
Cost
effective destruction |
| |
Destruction
options |
| |
Destruction
at the clinical site |
WHO SHOULD ATTEND
This program is designed for industry professionals
responsible for supervision, management, and/or technical duties related to
Clinical Trial Materials:
Lecturer: Joseph Saccamanno, MS, RPh
Joseph (Joe) Saccamanno is Manager, Worldwide Clinical Supplies Planning at
Schering-Plough. Joe has held various director positions, including Operations,
Project Management and Study Planning & Design. Joe holds a Master of Science
degree in Clinical Pharmacy, from St. John's.
Lecturer: Ellen Rocca, RN, BSN, MSJ
Ellen Rocca is a Manager, Field Operations, Clinical Operations Department at
Target Research Associates, Inc. Ellen's reponsibilities include CRA management
and development of training programs. Ellen has been in the field of clinical
research and has held positions such as Clinical Research Associate and Data
Manager. She hold Master of Science in Jurisprudence degree from Seton Hall
University School of Law.
Lecturer: Marty Jeiven, MS, RPh
Marty Jeiven is the President of Pharmaceutical Training Seminars, Inc., and
Jeiven Pharmaceutical Consulting, Inc., Scotch Plains, NJ.
FEE: ........$900 (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 $850 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 or money order. Please make payable to Pharmaceutical
Training Seminars, Inc.
SHERATON at WOODBRIDGE PLACE – ISELIN, NJ
(732) 634-3600 or (800) 325-3535
When making hotel reservations, please mention that you are attending the PTS
course. They have a block of rooms set aside at an attractive price. REGISTER
EARLY!!! Rooms are limited on these days at this location.
Registration will begin at 7:30 a.m. 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.
"Very Knowledgeable."
June Lato, Eisai
"I learned a lot about hazardous materials and waste materials. I did not
know much before coming to this program."
"Very useful program. Many details were covered and helped improve my
knowledge base."
John Ferinde, Fisher BioServices
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.
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 Karla Vasquez at (908) 654-4829
Send check (payable to PTS) to:
Karla Vasquez, Manager of Training Programs
Pharmaceutical Training Seminars, Inc.
6 Jacobs Lane
Scotch Plains, NJ 07076
PHARMACEUTICAL TRAINING SEMINARS, INC
E-Mail
| 
MANUFACTURE