MESSAGE
| DATE | 2005-11-15 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [NYLXS - HANGOUT] [Fwd: Press Release: Second Annual FDA Information Management
|
-----Forwarded Message-----
> From: Pharma Update News Service
> To: ruben-at-mrbrklyn.com
> Subject: Press Release: Second Annual FDA Information Management
> Summit Nov. 30 - Dec. 3, 2005
> Date: Tue, 15 Nov 2005 16:18:31 -0500
>
>
>
>
>
>
> PRESS RELEASE: FDAnews Presents the 2nd Annual FDA Information
> Management Summit: Delivering the Right Data, the Right Way on Nov. 30
> - Dec. 2, 2005
>
> PRESS RELEASE
> Phone: (888) 838-5578, (703)-538-7600
> Fax: (703) 538-7676
> Website: www.fdanews.com/infosummit
>
> WASHINGTON DC, USA -- PHARMA UPDATE NEWS SERVICE(TM) -- NOVEMBER 15,
> 2005: Evolving requirements and the FDA's new risk-based view of
> information management can transform your computer systems,
> applications and even email into warning letters, negative publicity
> and crippling delays.
>
> Before you buy software, assess risk or validate systems, you must
> know:
> * What the FDA expects: FDA insiders explain the agency's
> expectations for information management during 2006 - and the
> new approach and priorities for enforcement.
> * What industry advises: Compliance experts and practitioners
> from drug and device companies map out best strategies for
> managing information from R&D and trials to manufacturing and
> marketing.
> * What your colleagues are doing: Network with executives ready
> to share real-world experience on which software works best,
> what information management changes they're making, where
> unexpected problems arise and how they're fixing them.
> BENEFITS OF ATTENDING:
> * Learn how to use risk assessment in Part 11 compliance
> * Gain knowledge on how to prepare for risk-based inspections
> * Latest policies on esubmissions from CDER, CBER and CDRH
> * Best practices for system validation, erecords and esignatures
> * Strategies for safeguarding security, data integrity and
> privacy
> TOPICS:
> * Preconference Workshop: Strategies to Manage Risk in
> Electronic Records and Processes
> * Keynote Address: The FDA's Information Management Goals for
> 2006 and Beyond
> * Update on CBER's eSubmission Policies and Procedures
> * Better Understanding the FDA's Regulatory Expectations
> * Update on CDHR's eSubmission Policies and Procedures
> * Protecting the Security and Integrity of Clinical Trial Data
> * Update on Clinical Data Standards Consortium (CDISC) Standards
> * Data Privacy and HIPAA Concerns
> * Building and Maintaining Data Warehouses for Clinical Data
> * Best Practices for Computer System Validation and eRecords and
> eSignatures Compliance
> * SAFE-BioPharma Standards Update
> * Update on the Latest FDA eLabeling Requirements
> * FDA Enforcement and Computerized Systems Compliance
> * Importance of Initiatives Underway at the FDA to Better
> Facilitate Information Sharing Via
> * Electronic Means
> * Security of eRecords - Can I Still Use My System?
> * Utilizing Risk Assessment in Managing Part 11 Compliance
> * Spreadsheet Validation and Database Compliance Strategies
> EXPERTS FEATURED:
> * James Rinaldi, formerly chief information officer at the FDA,
> currently chief information officer of NASA's Jet Propulsion
> Laboratory, Keynote Speaker
> * Dr. Scott Gottlieb, deputy commissioner for medical and
> scientific affairs, FDA
> * Lisa Olson, principal consultant, SEC Associates (chairwoman)
> * Martin Browning, president, EduQuest
> * Gary Secrest, chief information security officer, Johnson &
> Johnson (chairman of the board SAFE-BioPharma Association)
> * Wayne Kubick, Sr. vice president and chief quality officer,
> Lincoln Technologies (leader of the Submission Data Standards
> team and CDISC technical director)
> * Gordon Richman, vice president of strategic compliance
> consulting and general counsel, EduQuest
> * Ty Mew, president, Ofni Systems
> * David Harrison, principal consultant, ABB Process Systems
> WHO WILL BENEFIT:
>
> This summit is especially designed for those involved with:
> * Regulatory affairs
> * IT management
> * QA/QC
> * Validation
> * Clinical trial data
> * Laboratory information
> * Software development
> * Internal and external communications
> * Corporate legal affairs
> Send Your Compliance Team for Maximum Benefit. Get state-of-the-art
> training for you and your team in just three days. Significant tuition
> discounts are available for teams of three or more people from the
> same company. You must register at the same time and provide a single
> payment to take advantage of the discount. Call +1 (703) 538-7600 for
> details.
>
> ABOUT THE LOCATION:
>
> Hyatt Regency Bethesda Hotel, Bethesda, Maryland (Washington, D.C.).
> Directly on the metrorail red line at Bethesda Metro Center, the Hyatt
> Regency Bethesda Hotel is central to Washington's world of life
> science companies, researchers and regulators. The hotel is minutes
> from FDA headquarters, the campus of NIH, Washington D.C.'s famed
> monuments and museums, Bethesda Naval Medical Center and Montgomery
> County's thriving biotechnology corridor.
>
> BONUS FOR ATTENDEES:
>
> Register at any time and receive a free 3-month subscription to
> FDAnews' PharmaDevice IT Report. This biweekly newsletter, provides
> case studies, expert interviews and practical advice on how to comply
> with 21 CFR Part 11 requirements and other technology initiatives at
> the FDA and in the industry.
>
> TUITION:
>
> 3 cost-effective learning options:
> 1. Complete Conference and Workshop Passport: $1,990 (you save
> $300 - the best value). Tuition includes the preconference
> workshop, all conference sessions, conference and workshop
> written materials, two breakfasts, two luncheons, one
> reception, refreshments and two certificates of attendance
> (workshop and conference).
> 2. Conference Sessions Only: $1,695 includes all conference
> presentations, conference written materials, two breakfasts,
> one luncheon, one reception, refreshments and a conference
> certificate of attendance.
> 3. Preconference Workshop Only: $595 includes the preconference
> workshop, workshop written materials, one luncheon,
> refreshments and a workshop certificate of attendance.
> Payment is required by the date of the conference. We accept American
> Express, Visa and MasterCard. Make checks payable to FDAnews.
>
> REGISTRATION INFORMATION:
>
> Register online at www.fdanews.com/infosummit for the FDAnews 2nd
> Annual Information Management Summit Conference
>
> Or Call: toll free (888) 838-5578 (inside the U.S.) or +1 (703)
> 538-7600.
>
> SATISFACTION GUARANTEED:
>
> You must be 100 percent satisfied with this learning opportunity or
> we'll refund your tuition or extend a credit to a future conference
> sponsored by FDAnews.
>
> SPONSORED BY:
>
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