Subject: DIA @ a Glance 04-26-2005

From: DIA <[email-masked]>
Date: Tue, 26 Apr 2005 14:11:21 -0400 (EDT)

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April 26, 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.

We are upgrading our internal accounting and customer management systems. As we work through all the processes associated with this upgrade, we appreciate your patience and understanding.

ANNUAL MEETING UPDATE
We have just mailed a print catalog with information about tutorials offered at the 41st Annual Meeting. But the complete list of tutorials is now available in your online preliminary program. Whether you register online for the meeting, tutorials, or networking dinner, or return the registration form in your preliminary program, it’s time to sign up to join us in Washington, DC, June 26 - 30.
http://www.diahome.org/annualmeeting2005/
Tutorials: http://www.diahome.org/Content/Events/05001.pdf#page=5
Registration Page: http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05001
Registration Form: http://www.diahome.org/Content/Events/05001.pdf#page=102
Online Preliminary Program: http://www.diahome.org/Content/Events/05001.pdf

May’s Featured European Offerings 
* 19 - 20 May: Regulatory updates at Better Medicines for Children: Current Regulatory and Scientific Status and Future Prospects in Helsinki, Finland, will specifically address the proposal for European Parliament and Council Regulation on paediatric research and licensing of medical products (Read the online programme).
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05103
http://www.diahome.org/Content/Events/05103.pdf

* 23 - 24 May: Europe’s leading industry experts 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).
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05102
http://www.diahome.org/Content/Events/05102.pdf

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

DIA Collaborations with FDA
* May 5 - 6: Explore imaging in the transition from preclinical to clinical drug development at Critical Path Opportunities: Use of Medical Imaging as a Drug Development Tool; Keynote speakers include Janet Woodcock, MD, Acting Deputy Commissioner of Operations, FDA, and George Mills, MD, Director, Medical Imaging and Radiopharmaceutical Drug Products, CDER, FDA. (Co-sponsored with the Biotechnology Industry Organization)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05017

* May 10: Exchange information and ideas about labeling and associated public health and regulatory concerns at FDA / DIA Cross-labeling Workshop: Combination Products and Mutually Conforming Labeling, an interactive public forum chaired by Suzanne M. O’Shea, Esq., Product Classification Officer, Office of Combination Products, FDA.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05028

* May 20: Satellite Video Conference: CDER Live! CDER’s Drug Safety Initiative, an overview of CDER’s drug safety and drug safety information initiatives, moderated by Deborah Henderson, Director, Office of Executive Programs, CDER, FDA, and featuring a taped interview with Janet Woodcock, MD, Acting Commissioner for Operations, FDA.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05035

Upcoming Webinar Calendar
* May 3, 12:00 - 1:30 PM, Standardised MedDRA® Queries: What Do They Mean to My Organization?
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05212

* 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.

“Best-in-Class” Professional Development from CC&PD
* May 2 - 4:  The Successful Negotiator - Updates include video role play and pre-course personal consultation with instructors (Philadelphia, PA)
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05453

* 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

* 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

Save Time and Money With In-house Training
In-house training delivers the same personal, comprehensive level of instruction as our traditional classroom training courses but at YOUR company location, saving you and your employees the time and expense of travel. For a list of available courses and other information, please contact [email-masked]. For information about in-house clinical investigator and investigative site personnel training, please contact [email-masked].

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

EUDRAVIGILANCE UPDATE
The EMEA, in collaboration with the Danish Medicines Agency, with DIA acting as conference organizer, will 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
Upcoming certification opportunities: Sit for the Certified Clinical Investigator examination review course on Saturday June 25, or for the certification examination on either the morning or afternoon of Sunday June 26, while attending the 41st Annual Meeting in Washington, DC. 
Examination Application: http://www.diahome.org/content/Events/Clinical_Investigator_Guide_Application.pdf
Review Course Application: http://www.diahome.org/Content/CIC/04441%20CCI%20Review%20Flyer.pdf
Annual Meeting: http://www.diahome.org/annualmeeting2005/

PROGRAMMING UPDATES
Call for Abstracts
Speaker Disclosure Form
http://www.diahome.org/DIA_TRAINING/Content/Education/Disclosure_form.DOC

6th European Electronic Document Management Conference: Know the Challenge, Define the Future
September 12 - 13 in Paris, France
Abstracts Deadline Extended to May 2
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05112

Four Worlds, One Vision: Delivering Quality Data Effectively
November 7 - 9 in Prague, Czech Republic
Abstracts Deadline Extended to May 2
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05117

3rd Canadian Annual Meeting: International Challenges for Therapeutic Products: Today’s and Tomorrow’s Policies and Strategies
September 25 - 27 in Montreal, Quebec, Canada
Abstracts Due May 2
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05024

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

EMEA / DIA EudraVigilance EVMPD Training Course 
April 28 in London, UK
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05545

Overview of Drug Development for Administrative Staff Training Course
May 2 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05444

European Regulatory Affairs Training Course
May 2 - 3 in Arlington, VA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05408

The Successful Negotiator Training Course 
May 2 - 4 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05453

Development of a Clinical Study Report Training Course
May 3 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05428

WEBINAR: Standardised MedDRA® Queries: What Do They Mean to My Organization?
May 3, 12:00 - 1:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05212

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/docs/Events/Events_search_detail.cfm?EventID=05515

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/docs/Events/Events_search_detail.cfm?EventID=05552

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/docs/Events/Events_search_detail.cfm?EventID=05432

EMEA / DIA EudraVigilance Training Course
May 17 - 19 in Hillerod, Denmark
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05543

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/docs/Events/Events_search_detail.cfm?EventID=05516

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

New Final Programs Posted This Week
WEBINAR: Standardised MedDRA® Queries: What Do They Mean to My Organization?
May 3, 12:00 - 1:30PM
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05212

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

New Preliminary Programs Posted This Week
10th Annual Computer Validation Conference: Validation Requirements in Predicate Rules - Is There a Need for Something More?
September 12 - 14 in Williamsburg, VA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05009

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