Dear Friends,
Today LSIT and Frost & Sullivan are launching a new survey to briefly explore some of the issues that came to light during our efforts over the last year, plus some that were raised with our last survey. We're hoping that you will take 10 minutes to give us your thoughts. Please spread the word among your colleagues as well. We want this as global and far reaching as possible.
See our new look of the LSIT website. The design will allow us to incorporate several new features in the coming months, and aims to provide a more attractive and useful environment for our visitors. Please take a moment to take a look and let us know what you think. We always appreciate the feedback.
Save the date! We're putting the finishing touches on a seminar to be held on December 4, 2007. Some of you might find this a good excuse to come to San Diego. More information will be forthcoming, in the meantime, mark your calendars.
Thank you all so much for your time in taking the survey.
- Anette
Briefly:
- Survey: We Need Your Input!
- Save the Date: 12/4/07
- Terry L. Schmidt, DrHA Joins Board
- Kudos to Vidya Lahoti
- HHS Issues Personalized Healthcare Report
- SQA Bioanalytical Seminar
- IVT's cGMP & GCP SOPs
New Survey Launched on Life Science IT
The LSIT Global Institute and Frost & Sullivan are conducting a new survey on "IT Practices Within Life Sciences Companies." It is designed to reach out to Life Sciences companies and their IT partners to gain a better understanding of the challenges faced in managing risks associated with the use of information technology for the life science industry.
The objectives of this 10-minute survey are to assist in understanding the impact of developing Good Informatics Practices (GIP) in life science IT, and to gauge the level of need within life science organizations for such guidance for improving quality and trust of IT within life sciences.
We hope that you'll take a few minutes and give us your expert opinion. Thank you!
Save The Date: LSIT December 4 Seminar
Mark your calendars! On the morning of Tuesday, December 4, 2007, LSIT will present a half-day seminar on the underpinnings of Good Informatics Practices. Participants will learn how GIP best practices and tactics are approached in the areas of IT Security, Data Management, Verification & Validation, and IT Infrastructure, and they will learn how our industry — with the help of GIP — can learn to trust IT with critical IP as much as we trust ATMs with our money.
Sponsorship opportunities are still available for this seminar as well. For more information, please contact anette@lsit.org.
LSIT Board Welcomes Dr. Terry L. Schmidt
The LSIT Board of Directors is pleased to announce the addition of our newest Board member, Terry L. Schmidt, DrHA. Dr. Schmidt is a health care executive who brings years of experience in government policy and regulation, and management of complex healthcare organizations.
Please join me in welcoming Terry to the organization - we're very fortunate to have him on board!
Kudos and Congrats to Vidya Lahoti
A big thank you and congratulations are in order for LSIT Volunteer/MBA Intern Vidya Lahoti. Vidya has been active with several of our groups, and she has spearheaded the creation and development of the new volunteer section at the revamped LSIT website. In addition, her company, Online Guru, Inc. recently made #9 on Inc. Magazine's list of America's Coolest 30 Entrepreneurs under 30.
So Kudos to you, Vidya; I'm immensely grateful to have you on board!
HHS Issues First Department-Wide Report on Personalized Health Care
Health and Human Services Secretary Mike Leavitt has released the first department-wide report on the goal of personalized health care and said work in biomedical science, health information technology and health care delivery should be aligned to produce "the right treatment, at the right time" for each individual patient.
The report, Personalized Health Care: Opportunities, Pathways, Resources, presents a long-range plan for achieving much more individualized treatment for patients, especially by using genetic information and health information technology (IT). Together, health information and IT can give clinicians better information about each patient and more support in choosing "best care" options for treatment.
Read more about the report here or download the report as a pdf (approx. 1Mb).
The SQA Presents Bioanalytical Instrument Qualification & Validation Symposium
On Friday, January 25, 2008, the Society of Quality Assurance (SQA) will hold a conference on Bioanalytical Instrument Qualification & Validation in Baltimore, MD. This one-day symposium will discuss the impact of the USP Chapter <1058> Analytical Instrument Qualification (AIQ) and holistic validation approach to the regulated bioanalytical laboratory.
For more information, please visit the SQA website.
IVT Releases Downloadable GMP & GCP SOPs
The Institute of Validation Technology, in association with Northwest Regulatory Support, has announced the release of 72 downloadable Standard Operation Procedures (SOP's) for current Good Manufacturing Practices (cGMP's) and Good Clinical Practices (GCP's). These SOP's have been developed to provide you a comprehensive document framework that meets Quality System requirements for Medical Devices or applicable requirements for drugs and biological products.
For a directory and pricing, please visit the download site.
