7th Annual Pharmaceutical Stability Programs

Venue: The Ritz Carlton Philadelphia

Location: Philadelphia, United States

Event Date/Time: Dec 08, 2003 End Date/Time: Dec 10, 2003
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Description

The Institute for International Research is proud to bring you the 7th annual Pharmaceutical Stability Programs industry gathering. The mission of this program is to present specific information on how to achieve maximum efficiencies in analytical stability testing and related regulatory processes, ultimately to drive down the risk of unexpected costs. In the current regulatory environment that focuses heavily on risk management, the FDA is closely examining stability data to ensure safety for patients and consumers. This 7th annual conference addresses this focus within three discreet sections to ensure a thorough and comprehensive stability program: stability lab infrastructure, analytical test method, and regulatory/QA stability requirements, which clarify the FDA and ICH Guidelines. This December, the speaking faculty illustrates regulatory compliance challenges of stability, interprets the FDA paradigm for combination products stability testing, weighs the economic advantages and disadvantages of bracketing and matrixing design, and provides examples of how drug manufacturers can strategically determine endpoints.

The risk of not conducting thorough stability
testing outweighs the cost of performing it.


We are proud to bring you stability experts from, ABBOTT LABORATORIES, ARRIVA PHARMACEUTICALS, INC., BAXTER, BERLEX BIOSCIENCES, CHARLES RIVER LABORATORIES, ELAN DRUG DELIVERY, ELI LILLY, GLAXOSMITHKLINE, JOHNSON AND JOHNSON, IVAX, INC, PHARMANET, INC, PFIZER, INC. as well as a former deputy director, division of new drug chemistry II, CDER, FDA and more who are currently working on improving their stability & programs. Together, they represent a diverse array of pharmaceutical companies who share their experiences through detailed case studies.


SHAPE OF THE PROGRAM AGENDA
Join us Day One December, 8th, for a full day pre-conference workshop on Building a Pharmaceutical Stability Testing Laboratory from Scratch, led by Collin Scott Vice President, Clinical And Regulatory Affairs, ARRIVE PHARMCEUTICALS and Joe Patterson, President and CEO, WESTPOINT PHARMCEUTICAL CONSULTING focused on the processes of developing the infrastructure, logistics, regulatory, and human aspects of a stability lab.. The half-day morning workshop on Considerations for Selecting and Configuring a LIMS Stability Application led by Randy C. Hice, CEO LABORATORY EXPERTISE CENTER INC addresses barriers to success and LIMS project challenges. The half-day afternoon workshop Designing and Comprehension of Practical Considerations in Stability Studies, led by Professionals from: GENZYME, BIOMARIN PHARMACEUTICALS INC, and CHARLES RIVER LABORATORIES BIOPHARMACEUTICAL SERVICES takes an in-depth look at preventative strategies for understanding the risks in stability studies.

The morning of Day Two, December 9th, kicks off the main conference by focusing on stability lab infrastructure, beginning with a brief introduction by our distinguished chairperson, Paul Newton, PhD, Technical Project Manager, GLAXOSMITHKLINE. Tap into the knowledge and experience base of stability professionals and hear how:

BAXTER HEALTHCARE CORPORATION identifies current bracketing and matrixing designs to avoid unnecessary testing
ABBOTT LABORATORIES implements test delay accountability systems
JOHNSON AND JOHNSON avoids stability OOS and failures
IVAX validates international test methods to assure assay integrity
MERCK AND CO. mitigates risk through proper statistics analysis of stability data
Day Three, December 10th, focuses on streamlining both efficiencies and compliance to regulatory and QA requirements for your stability program. Hear from the former Deputy Director, Division of New Drug Chemistry, as he expands on the rationale of current FDA stability requirements. In addition, learn how to:

Leverage a former CDER employees’ regulatory knowledge to help improve your interactions with FDA
Discover key properties to successful OTC stability programs with PFIZER CONSUMER HEALTHCARE
ELAN DRUG DELIVERY streamlines stability project management and communication for improved program management
The Pharmaceutical Stability Program conference offers case studies that illustrate the specific challenges of stability programs through all phases of testing. Take this opportunity to learn how to develop and adapt your stability program to decrease the risk of getting results you did not expect. It is a conference designed for the range of professionals working in pharmaceutical stability areas including: R&D, Manufacturing, QA/QC and Regulatory Affairs.


Key Opportunity for Learning and Networking
Join the Pharmaceutical Stability Programs conference that clarifies strategies to reduce cost of stability programs for pharmaceutical companies of all sizes, address the specific obstacles that challenge stability professionals, and learn strategies for overcoming compliance, software, changing ICH guidelines, OOS/OOT’s, and validation roadblocks.We have included panel discussions at critical points in the program to ensure that you have ample opportunity to voice your questions, clarify your interpretation of our faculty’s recommendations and openly exchange your experiences for maximum learning. In addition, refreshment breaks and round table luncheons are planned to enhance your networking opportunities. Don’t miss this unique opportunity to talk one-on-one with our experts, meet with industry colleagues to compare notes and establish contacts with others who are facing the similar challenges in all phases of stability testing. You also receive a copy of the conference documentation, a valuable tool to take back to your office for future reference.

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