Subject: Have Questions About FDA's New Indexing Structured Product Labeling Draft Guidance?

From: DIA <[email-masked]>
Date: Wed, 2 May 2007 16:24:24 -0400 (EDT)

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Dear David Harris:

The Drug Information Association (DIA) would like to invite you to a must-attend conference on Indexing Structured Product Labeling: Clinical and Practical Approaches Using Data Elements in SPL Conference http://recp.rm05.net/ctt?kn=1&m=563245&r=NDIyMzA5NDU5OQS2&b=2&j=ODQ2NTc2NTkS1&mt=1
from May 17-18, 2007, in Washington, DC.  This conference has been developed to facilitate open discussion regarding FDA’s Draft Guidance for Industry.  We have worked together with the co-chairs of this program LILLIAM ROSARIO, PHD, Office of New Drugs-Immediate Office, CDER, FDA and LEANDER FONTAINE, MD Pharmiceutics LLC and key thought leaders from FDA and industry, as well as terminology experts at SNOMED CT® and the Veterans Administration National Drug File Reference Terminology to bring this program to you.

Unique Opportunity to Have Key FDA Representatives Answer Your Questions About the Draft Guidance

WHY YOU MUST ATTEND
- Learn How SPL indexing will greatly improve the effectiveness of prescription drug labeling for risk management
- Learn about the draft guidance on SPL indexing from agency representatives.
- Learn insights that allow you to write more targeted comments on FDA’s draft SPL Indexing guidance

WHO SHOULD ATTEND

Professionals who work with product labeling from a regulatory, medical/pharmacovigilance, and clinical decision support systems perspective and/or are involved in pharmaceutical risk management and in efforts to increase medication safety.

Print A Copy of the Updated Program>>  ( http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f13558%2f07014.pdf )

Register Online>>  ( http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=13558&eventType=Meeting )

PROGRAM CHAIRPERSONS/PRESENTERS

Leander Fontaine, MD, Pharmiceutics LLC
Lilliam Rosario, PhD, Office of New Drugs-Immediate Office, CDER, FDA

PROGRAM COMMITTEE/PRESENTERS

- Sidney N. Kahn, MD, PhD, President, Pharmacovigilance and Risk Management, Inc.
- Randy Levin, MD, Director for Health and Regulatory Data Standards, FDA
- Liora Alschuler, Consultant; Member of HL7 Board of Directors; Co-chair, HL7 Structured Documents Technical Committee, Alschuler Associates, LLC
- Dawn M. Bartizal, Senior Director, Global Labeling, Wyeth Pharmaceuticals
- Joan E. Kapusnik-Uner, PharmD, FCSHP, Manager, Disease Decision Support Group, First DataBank, Associate Clinical Professor, University of California, San Francisco School of Pharmacy
- Michael J. Lincoln, MD, Chief Terminologist, Department of Veterans Affairs, Associate Professor, Medicine and Medical Informatics, University of Utah
- Doris J. McGinness, Pharmacy Terminology Manager, SNOMED International
- Gunther Schadow, MD, PhD, Research Scientist, Regenstrief Institute, Associate Professor of Informatics, Indiana University School of Informatics
- James Shalaby, PharmD, Chief Informatics Consultant, Practical Solutions in Medical Informatics Consulting, LLC
- Mary Beth Wilusz, Associate Director, Global Labeling Systems, Worldwide Product Labeling, Merck & Co. Inc.

Contact Information

Conference: Jessica Kusma, Program Manager
Phone +1-215-442-6182, Fax +1-215-442-6199, email [email-masked]

Tabletop Exhibit Opportunities Available! 

Exhibits: Erin Gilliland 
Phone +1-215-442-6149, Fax +1-215 442-6199, email [email-masked]

Drug Information Association | 800 Enterprise Road Suite 200 | Horsham, PA 19044
T. +1.215.442.6100 | F.+1.215.442.6199 | email: [email-masked]
mailto:[email-masked]

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