Subject: DIA @ a Glance 03-14-2005

From: DIA <[email-masked]>
Date: Mon, 14 Mar 2005 15:12:43 -0500 (EST)

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"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.

ANNUAL MEETING UPDATE
“Trust, Relationships and the Negotiation Process,” just added to the tutorial schedule! Keep reading your online preliminary program for our 41st Annual Meeting, June 26 - 30 in Washington, DC, for the updated session schedule, updated tutorial topics, tutorial pricing, and housing information. Register online, or return the registration form in your online preliminary program, to join us!
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05001
http://www.diahome.org/Content/Events/05001.pdf

Early Registration Di$count Window Soon Closing
Register by March 21 for Best-in-class Clinical Supply Units and Breakthrough Technologies (April 11 - 13 in Philadelphia, PA) and save $130, or by March 21 for Better Processes for Patient Recruitment and Retention: Understanding Volunteers and Their Perspectives (April 12 - 13 in Philadelphia, PA) and save $125!
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05012
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05015

Special Exhibitors’ Invitation to Our FIRST Multitrack Offering in Japan
EuroMeeting and 41st Annual Meeting exhibitors: Don’t miss your opportunity to showcase your products and services in one of the industry’s most exciting markets, as an international panel of experts presents The FIRST Multitrack Meeting in Japan: DIA Congress on the Development and Utilization of Pharmaceuticals, September 29 - 30 in Tokyo. Please contact [email-masked] or read your online meeting program to learn more.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05303
http://www.diahome.org/Content/Events/05303.pdf

Two Decades of Excellence
Our Annual Clinical Data Management Symposium and Exhibition, April 3 - 6 in Arlington, VA, celebrates its second decade as a hallmark DIA offering with entry- and advanced-level topics, FDA and technology updates, and several sessions offered for the first time! Parallel tracks address such essential CDM subjects as CDISC, contract research organizations, EDC / e-PRO, medical terminology, professional development, project management, SAS, and systems and processes. Come join the celebration! 
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05004
http://www.diahome.org/Content/Events/05004.pdf

Only at ePRO
Everyone who is anyone in the regulatory ePRO and Measurement Validation worlds is planning to attend Benefits and Challenges of ePRO: Outcomes and Endpoints as We Emerge From the Long Age of Paper Methods, April 4 - 5 in Arlington, VA. Confirmed participants include Dr. Gordon Guyatt, McMaster University; Richard Gracely, University of Michigan, Ann Arbor; and David Iberson-Hurst, Assero Limited. Registered ePRO participants can also visit the CDM Exhibit Hall and Reception at the Hyatt Crystal City Hotel on Sunday April 3 from 4:00 to 6:00PM for FREE!
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05011

FREE Introductory eLearning Module
Take our new History of US Drug Regulation eLearning module free of charge! Learn more about a topic of essential importance to industry and regulatory professionals AND discover the benefits of DIA eLearning for yourself, for FREE! Look for a new, comprehensive global training communication later this week!
http://www.diahome.org/docs/education/elearning_free_detail.cfm?eventid=05701

FDA Leadership Confirmed for NEW Webinar, March 30
Presented by Ajaz Hussain, PhD, Deputy Director, Office of Pharmaceutical Science, CDER, FDA, 
ICH Q8 Pharmaceutical Development: FDA Draft Guidance will analyze the Step 2 ICH Q8 document that suggests contents for the 3.2.P.2 Pharmaceutical Development section of a regulatory submission in the ICH M4 CTD format. Join us online from 12:30 to 1:30PM EST; your online webinar flyer has all the details. Other hot-topic March webinars include The New Era of Transparency in Clinical Research: Evolution of Clinical Trial Registers and Registries, on March 23, 12:00 - 1:30PM EST; and Quality Systems and Compliance Framework, on March 31, 12:00 - 1:30PM EST.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05227
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05209
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05226

Collaborative and Informative
*The Use of ECGs in Clinical Trials: A Public Discussion of the Proposed ICH E14 Regulatory Guidance, April 11 - 12 in Bethesda, MD, featuring panelists from the International Committee on Harmonization E14 and S7B Working Groups, co-sponsored with FDA and the Heart Rhythm Society.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05029

*Pharmacogenomics in Drug Development and Regulatory Decision Making: Workshop 3: Three Years of Promise, Proposals, and Progress on Optimizing the Benefit / Risk of Medicines, April 11 - 13 in Bethesda, MD, co-sponsored with FDA, Pharmacogenetics Working Group, PhRMA, and Biotechnology Industry Organization.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05013

Time to Vote
DIA members are asked to vote for several 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. 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

NPR’s “Justice Talking” by U/Penn’s Annenberg Center to Focus on Drug Approval Debate
“Drug Approval and the FDA” will be taped Tuesday, March 15, 5:00 to 6:30PM at the National Constitution Center in Philadelphia, PA. Guests will include Dr. Robert Siegel, Senior Vice President, Medical Affairs and Chief Medical Officer, Schering-Plough Research Institute (a DIA member), and Dr. Alastair Wood, Associate Dean and Professor of Medicine and Pharmacology, Vanderbilt University School of Medicine. The show’s air date is TBA. Call 215.573.8919 to reserve your free seat in the audience or reserve it online. You can submit questions or comments online, too!
http://www.justicetalking.org/joinaudience.asp
http://www.justicetalking.org/sendquestion.asp?progID=501

EUROMEETING UPDATE
Thank you to everyone who contributed to the success of our 17th Annual EuroMeeting in Lisbon! Preparations are already underway for our 18th Annual EuroMeeting: Molecules to Medicines - Better, Safer, Faster, in Paris, France, from March 6 - 8, 2006. We are already reviewing ideas for the 2006 EuroMeeting, so please submit your session abstract by April 1, 2005. Your online Call for Abstracts has all the details.
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=06101
http://www.diahome.org/Content/Events/06101.pdf

EUDRAVIGILANCE UPDATE
The EudraVigilance data-processing network and management system allows for the efficient exchange of pharmacovigilance data between the EMEA, National Competent Authorities, and pharmaceutical companies that hold marketing authorizations in the European Economic Area. DIA is proud to serve as conference organizer for the ONLY EudraVigilance training officially recognized by the EMEA! View the complete EudraVigilance training course schedule -- AND register -- online! 
http://www.diahome.org/EudraVigilance/course_registration.cfm

CLINICAL INVESTIGATOR UPDATE
Our Good Clinical Practices for the Clinical Research Professional training course, April 8 in Houston, TX, gives clinical investigators and study staff the practical and regulatory knowledge you need to conduct safe and effective clinical trials. Register online, or return the registration form in your online training course flyer. 
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05457
http://www.diahome.org/Content/Events/05457.pdf

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

Challenges in the Development of Therapeutic Products
November 6 - 8 in San Diego, CA
Abstracts Due April 1
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05022

18th Annual EuroMeeting - Molecules to Medicines: Better, Safer, Faster
March 6 - 8, 2006, in Paris, France
Abstracts Due April 1
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=06101

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

Difficult Relationships: Having Conversations that Work
March 21 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05426

WEBINAR: The New Era of Transparency in Clinical Research: Evolution of Clinical Trial Registers and Registries 
March 23, 12:00 - 1:30PM EST
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05209

Certified Clinical Investigator Examination
March 26 in Dallas, TX
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=50301

WEBINAR: ICH Q8 Pharmaceutical Development: FDA Draft Guidance
March 30, 12:30 - 1:30 PM EST
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05227

WEBINAR: Quality Systems and Compliance Framework
March 31, 12:00 - 1:30PM EST
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05226

Certified Clinical Investigator Examination Review Course
April 3 in Arlington, VA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05406

Certified Clinical Investigator Examination
April 3 in Arlington, VA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=50401

20th Annual Clinical Data Management Symposium and Exhibition
April 3 - 6 in Arlington, VA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05004

Managing Multiple Priorities for Clinical Research Professionals Training Course
April 4 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05443

Benefits and Challenges with ePRO: Outcomes and Endpoints as We Emerge from the Long Age of Paper
April 4 - 5 in Arlington, VA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05011

Regulatory I: The IND Phase Training Course
April 4 - 6 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05427

Advanced Topics in Clinical Research / Drug Development Training Course
April 4 - 6 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05450

Fundamentals of Clinical Research Monitoring Training Course
April 4 - 6 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05452

EMEA / DIA EudraVigilance Training Course
April 4 - 6 in London, UK
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05512

Drug Safety Surveillance and Epidemiology Training Course
April 6 - 8 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05445

Good Clinical Practices for Clinical Research Professionals
April 8 in Houston, TX
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05457

Best-in-class Clinical Supply Units and Breakthrough Technologies
April 11 - 13 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05012

Use of ECGs in Clinical Trials: A Public Discussion
April 11 - 12 in Bethesda, MD
Co-sponsored by FDA, the Heart Rhythm Society, and DIA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05029

Pharmacogenomics in Drug Development and Regulatory Decision Making
April 11 - 13 in Bethesda, MD
Co-sponsored by FDA, Pharmacogenetics Working Group, PhRMA, Biotechnology Industry Organization, and DIA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05013

Better Processes for Patient Recruitment and Retention: Understanding Volunteers and Their Perspectives
April 12 - 13 in Philadelphia, PA
http://www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=05015

New Final Programs Posted This Week 
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

Other Meetings of Interest
Evaluation and Use of Medicinal Products During Pregnancy: The Double Risk 
March 17 - 18 in Brussels, Belgium 
Presented by EudiPharm 
http://www.eudipharm.net/

2005 Clinical Research Educational Conference and Career Fair
May 6 in Chicago, IL
Presented by Northwestern Center for Clinical Research in collaboration with DIA
http://www.regonline.com/Checkin.asp?EventId=19021&RegTypeID=38510

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