Subject: DIA @ a Glance 05-02-2005

From: DIA <[email-masked]>
Date: Mon, 2 May 2005 15:34:19 -0400 (EDT)

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May 2, 2005
"DIA @ a Glance" is a weekly update and is NOT an all-inclusive list of DIA activities and events. Please pass these updates along to your colleagues.

NEW DIA MISSION AND VISION STATEMENTS
The quarterly DIA Board of Directors meeting held at the EuroMeeting in Lisbon focused on the future vision of the association. In the course of defining this future vision, the Board reviewed DIA’s values, core competencies, and its unique strategic position in the drug development industry. From this review, the Board developed and approved an updated Mission Statement and Vision Statement.
http://www.diahome.org/docs/AboutUs/AboutUs_mission.cfm

TIME TO VOTE
DIA members are asked to vote for positions on the Board of Directors and other association leadership. Vote online or with the paper ballot you received with your March issue of DIA Today. Voting kiosks will also be available at the Annual Meeting. Whether you vote online or on paper, please vote before the polls close on June 30.
https://www.diahome.org/secure/survey/Survey_form.cfm?Survey_ID=9

ANNUAL MEETING UPDATE
DIA welcomes the Galileo Players to the Annual Meeting Networking Dinner, 6:30PM on Sunday June 26. This professional sketch comedy and improvisational troupe analyzes the foibles of reason, science, and logic with original songs, sketches, and improvisations. New registrants: Simply check the “Networking Dinner” box under “Available Subevents” to include the Networking Dinner in your online Annual Meeting registration. If you’re already registered, complete and return the registration form in your online preliminary program to ADD the Networking Dinner to your registration. Networking Dinner attendance is limited; onsite registration CANNOT be guaranteed. 
Main Annual Meeting Page: http://www.diahome.org/annualmeeting2005/
Online Registration Page: http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05001
Online Preliminary Program: http://www.diahome.org/Content/Events/05001.pdf
Registration Form From Program: http://www.diahome.org/Content/Events/05001.pdf#page=102

FEATURED MAY PROGRAMS IN EUROPE
* 19 - 20 May: Learn the latest regulatory status of the proposal for European Parliament and Council Regulation on paediatric research and licensing of medical products at Better Medicines for Children: Current Regulatory and Scientific Status and Future Prospects in Helsinki, Finland (Read the online programme at: http://www.diahome.org/Content/Events/05103.pdf).
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05103

* 23 - 24 May: Leading European industry experts identify and detail proven techniques for Maximising Strategic Alliances: Successfully Charting New Horizons: Critical Decisions: From “Proof of Concept” to Profitable Partnerships in Vienna, Austria (Read the online programme at: http://www.diahome.org/Content/Events/05102.pdf).
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05102

* 30 - 31 May: Explore the FDA “Critical Path” initiative and other hot topics within the regulatory, preclinical and clinical aspects of drug development and post-registration vigilance, at Regulatory Preclinical-Clinical Conference: Safety – Strategy - Regulations in Hamburg, Germany (Read the online programme at: http://www.diahome.org/Content/Events/05110.pdf).
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05110

DIA COLLABORATES WITH FDA TO PRESENT
* Keynote speakers Janet Woodcock, MD, Acting Deputy Commissioner of Operations, FDA, and George Mills, MD, Director, Medical Imaging and Radiopharmaceutical Drug Products, CDER, FDA, on the first day of Critical Path Opportunities: Use of Medical Imaging as a Drug Development Tool, May 5 - 6 in Bethesda, MD. (Co-sponsored with the Biotechnology Industry Organization)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05017

* Suzanne M. O’Shea, Esq., Product Classification Officer, Office of Combination Products, FDA, serving as chair for the interactive public forum FDA / DIA Cross-labeling Workshop: Combination Products and Mutually Conforming Labeling, May 10 in Bethesda, MD.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05028

* Deborah Henderson, Director, Office of Executive Programs, CDER, FDA, serving as moderator for Satellite Video Conference: CDER Live! CDER’s Drug Safety Initiative, an overview of CDER’s drug safety and drug safety information initiatives (also features a taped report from Janet Woodcock, MD, Acting Commissioner for Operations, FDA).
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05035

MAY WEBINARS: ONLINE SEMINARS YOU ATTEND FROM YOUR OWN HOME OR OFFICE
* May 4, 12:00 - 1:30 PM, Regulatory Implications of CMC Change Control
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05213

* May 5, 12:00 - 1:30 PM, Guiding Appropriate Use of Medications by Healthcare Providers and Patients
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05214

* May 5, 2:30 - 3:30 PM, Pediatric Safety Reporting and Oversight: What Was Learned From the FDA February Pediatrics Advisory Committee Public Meeting 
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05231

* May 6, 12:00 - 1:30 PM, Cross-indemnification and Other Legal Issues Facing Investigators and Investigative Sites
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05228

* May 18, 12:00 - 1:30 PM, CDISC and eCTD: Converging Standards
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05215

* Site pricing discounts available! Please contact [email-masked] for more details.

CC&PD "SUMMER SCHOOL" HIGHLIGHTS
* May 16 - 18: Project Management (San Francisco, CA)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05419

* May 16 - 19: Combined Regulatory Affairs (West Chester, PA)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05432

* May 16 - 19: The Leadership Experience, presented in cooperation with LeaderPoint (St. Louis, MO)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05402

* May 18 - 20: Entry Level Clinical Biostatistician (Baltimore, MD)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05429

* May 23 - 24: Advanced Clinical Statistics for Nonstatisticians (Philadelphia, PA)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05420

* Just Added! June 6: Overview of Drug Development for Administrative Staff (Philadelphia, PA) Recent offering of this course sold out - Please contact [email-masked] for registration information.

* June 8 - 10: Regulatory Path for Medical Devices, presented in cooperation with the University of Southern California School of Pharmacy (Los Angeles, CA)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05442

EUDRAVIGILANCE UPDATE
DIA will serve as conference organizer for the EMEA, in collaboration with the Danish Medicines Agency, to present EudraVigilance Training from 17 - 19 May in Hillerød, Denmark. The course will be instructed by EudraVigilance trainers and participants will receive formal certification equivalent to courses held at the EMEA in London. Download the training course flyer for complete details.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05543
http://www.diahome.org/Content/Events/05543.pdf

CERTIFIED CLINICAL INVESTIGATOR UPDATE
DIA’s Certified Clinical Investigator Program now features two new eLearning Modules. Follow our fictitious clinical investigator and his team through the entire course of a clinical study, and learn the regulations, processes, and best practices for conducting safe and effective clinical trials. It’s a great way to prepare for the Certified Clinical Investigator examination, to earn continuing education credits, and improve your professional practice. Contact [email-masked] to learn more.
http://www.diahome.org/docs/CIC/CIC_Index.cfm
http://www.diahome.org/docs/Education/elearning_detail.cfm?bundle=ELRNBUNDLE03
http://www.diahome.org/docs/CIC/CIC_exam_dates.cfm

PROGRAMMING UPDATES
CALL FOR ABSTRACTS
Speaker Disclosure Form
http://www.diahome.org/DIA_TRAINING/Content/Education/Disclosure_form.DOC

International Issues and Perspectives on Medical / Technical Writing and Document Preparation for the Pharmaceutical Industry and Regulatory Agencies
October 17 - 18 in Bethesda, MD
Abstracts Due June 6
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05034

TIME TO REGISTER
Please look under "Meetings" on our homepage for a complete meeting list. You can search by meeting date or key word.
http://www.diahome.org/docs/Events/Events_index.cfm

WEBINAR: Regulatory Implications of CMC Change Control
May 4, 12:00 - 1:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05213

WEBINAR: Guiding Appropriate Use of Medications by Healthcare Providers and Patients
May 5, 12:00 - 1:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05214

WEBINAR: Pediatric Safety Reporting and Oversight: What Was Learned From the FDA February Pediatrics Advisory Committee Public Meeting 
May 5, 2:30 - 3:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05231

Critical Path Opportunities: Use of Medical Imaging as a Drug Development Tool
May 5 - 6 in Bethesda, MD
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05017

WEBINAR: Cross-indemnification and Other Legal Issues Facing Investigators and Investigative Sites
May 6, 12:00 - 1:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05228

Clinical Research Educational Conference and Career Fair
May 6 in Chicago, IL
In partnership with the Northwestern Center for Clinical Research
http://www.nccr.northwestern.edu/educational_events/ed_conference_DIA_2005.htm

FDA / DIA Cross-labeling Workshop: Combination Products and Mutually Conforming Labeling
May 10 in Bethesda, MD
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05028

EMEA / DIA EudraVigilance Training Course
May 11 - 13 in London, UK
http://www.diahome.org/Content/Events/05515.pdf

Project Management Training Course
May 16 - 18 in San Francisco, CA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05419

EMEA / DIA EudraVigilance Training Course
May 16 - 18 in Prague, Czech Republic
http://www.diahome.org/Content/Events/05522.pdf

The Leadership Experience Training Course
May 16 - 19 in St. Louis, MO
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05402

Combined Regulatory Affairs Training Course
May 16 - 19 in West Chester, PA
http://www.diahome.org/Content/Events/05432.pdf

EMEA / DIA EudraVigilance Training Course
May 17 - 19 in Hillerod, Denmark
http://www.diahome.org/Content/Events/05543.pdf

WEBINAR: CDISC and eCTD: Converging Standards
May 18, 12:00 - 1:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05215

Entry Level Clinical Biostatistics Training Course
May 18 - 20 in Baltimore, MD
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05429

EMEA / DIA EudraVigilance Training Course
May 18 - 20 in London, UK
http://www.diahome.org/Content/Events/05516.pdf

Better Medicines for Children: Current Regulatory and Scientific Status and Future Prospects
May 19 - 20 in Helsinki, Finland
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05103

Satellite Video Conference: CDER Live! CDER’s Drug Safety Initiative
May 20, 1:00 - 4:00 PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05035

Advanced Clinical Statistics for Non-statisticians Training Course
May 23 - 24 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05420

Maximising Strategic Alliances: Successfully Charting New Horizons: Critical Decisions - From “Proof of Concept” to Profitable Partnerships
May 23 - 24 in Vienna, Austria
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05102

EMEA / DIA EudraVigilance Training Course
May 23 – 25 in London, UK
http://www.diahome.org/Content/Events/05517.pdf

EMEA / DIA EudraVigilance EVMPD Training Course
May 26 in London, UK
http://www.diahome.org/Content/Events/05546.pdf

Regulatory Preclinical - Clinical Conference: Safety - Strategy - Regulations
May 30 - 31 in Hamburg, Germany
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05110

Drug Information Association, 800 Enterprise Road Suite 200, Horsham, PA 19044.
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