Showing posts with label Clinical Data Management. Show all posts
Showing posts with label Clinical Data Management. Show all posts

Wednesday, January 2, 2013

Be a Part of Japan's Most Amazing CDM Workshop! - 本ワークショップへ、ぜひご参加ください


16th Annual Workshop
in Japan for Clinical Data Management SMART CDM | February 7-8, 2013 | Tower Hall Funabori, Tokyo, Japan
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Be a Part of Japan's Most Amazing CDM Workshop!
Dear Colleague,
As a past participant of DIA Japan CDM Workshop you know that DIA brings together global regulatory professionals to share past experiences and practice new skills in Clinical Data Management. This workshop seeks to improve the quality of clinical research and data management activities.  We know that you have been a part of DIA’s CDM events in the past, so we invite you to interact with CDM and other professionals.
The workshop this year is utilizing many components:
  • Standardization, Safety, Speedy, Strategy, Simplification
  • Management, Metrics, Metadata, Multinational
  • Assurance, Asia, Adaptive design, Accuracy
  • Risk based approach, Regulation, Reliability, Relationship
  • Technology, Teamwork, Terminology, Translate
This is an important workshop for DIA Japan and we want you to be SMART and register!
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本ワークショップへ、ぜひご参加ください
各位

これまでにCDMワークショップへご参加頂きありがとうございました。
そこで習得された知識や経験を生かして、一層ご活躍のことと存じます。

2013
年のワークショップでは、臨床研究の質およびデータマネジメント活動の向上を目的に、
以下のトピックスからセッションを組む予定です。
  • Standardization, Safety, Speedy, Strategy, Simplification
  • Management, Metrics, Metadata, Multinational
  • Assurance, Asia, Adaptive design, Accuracy
  • Risk based approach, Regulation, Reliability, Relationship
  • Technology, Teamwork, Terminology, Translate
新たなネットワークを築く良い機会でもありますので、ぜひ今一度ご参加をご検討ください。
皆様の積極的なご参加をお待ちしております。
Email Preferences    |    My DIA    |    Forward to a Friend    |    FacebookLinkedInTwitterYouTubeFlickr

Monday, August 13, 2012

CALL FOR ABSTRCTS: 16th Annual Workshop in Japan for Clinical Data Management: SMART CDM ends 8/25

Meeting Date:
2/7/2013 8:30:00 AM - 2/8/2013 5:00:00 PM       
Location:
Tower Hall Funabori 4-1-1 Funabori Edogawa-ku Tokyo 134-0091 Japan       
Overview:
It’s the 16th DIA Clinical Data Management workshop in Japan. As the international meeting for professionals, we encourage all levels, from beginners to experts, to participate this annual meeting. And we hope to provide a more sophisticated program. Changes in the world are very fast. Especially ‘Information’ and ‘Technology’ are growing to be complex, globalize, and mass. However, we can hear the word ‘smart’ here and there recently. Because people don’t hope to be swayed by them, people hope to take advantage of them. We think that the environment surrounding the CDM is similar to this. Therefore the theme was determined to “SMART CDM”. Because we would like to consider with you how we can be a smart CDM. This workshop is expected to form a sessions on the following topics.
  • Standardization, Safety, Speedy, Strategy, Simplification
  • Management, Metrics, Metadata, Multinational
  • Assurance, Asia, Adaptive design, Accuracy
  • Risk based approach, Regulation, Reliability, Relationship
  • Technology, Teamwork, Terminology, Translate
Objectives of this workshop are to improve the quality of clinical research and data management activities. This annual workshop will provide information to attendees about the international clinical data management, and attendees will get opportunities to network with colleagues in global Clinical Data Management.

Target Audience:
  • Clinical data managers
  • Clinical research coordinators
  • Biostatisticians
  • Clinical development professionals
  • Information technology professionals
  • QC/QA professionals
  • Regulatory affairs professionals

Continue Abstract Submission

Friday, April 20, 2012

FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical Devices

In the News...


FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical DevicesIn an attempt to improve the predictability, consistency and transparency of the medical device review process, the U.S. Food and Drug Administration (FDA) released final guidance describing the principal factors the agency will consider when making benefit-risk determinations during the premarket approval and de novo classification processes, respectively.
 
Read More

Related Event:  Clinical Data Quality Summit  |  April 24-25 | PhiladelphiaThe Clinical Quality Data Summit is a mix of plenary and breakout sessions with specific tracks on various clinical quality data interest areas. You will learn ways to utilize new tools and technologies and how to partner with different research professionals to operate more efficiently and contain costs. Case studies, a Q&A, and tabletop exhibits round out the summit.
 
Register Now

Friday, April 6, 2012

Clinical Data Management/eClinical


In the News...

Clinical Data Management/eClinical

Sanofi and Regeneron Announce Regulatory and Clinical Update for ZALTRAP® (aflibercept) ZALTRAP BLA for metastatic colorectal cancer granted priority review by FDA; drug phase III study in prostate cancer did not meet primary endpoint. Read more...

Clinical Data Quality Summit
April 24-25 | Philadelphia, PA
DIA - Drug Information Association
Learning Objectives:At the conclusion of this conference, participants should be able to:• Describe tools, technologies, and techniques that impact data quality
• Discuss best practices to ensure successful design of studies, while embracing standards
• Define who to include during the study start up phase to ensure that all elements are addressed
• Explain how research professionals can work effectively together during the conduct of a clinical trial
• Identify steps to successfully clean and lock a database by establishing partnerships with clinical and biostatistics
• Discuss regulatory expectations for quality data and recommendations for study start, conduct and closeout
Target Audience:
• Data managers
• Clinical project managers
• Clinical research coordinators
• Principal investigators
• Data standards personnel
• Monitors
• Quality assurance personnel
• Regulators
• Statisticians
• Clinical programmers


Introduction to Computer Systems Validation
Begins April 30 | Online
DIA - Drug Information Association
Learning Objectives:At the conclusion of this activity, participants should be able to:
· Contribute positively to a project
· Validate a computer system
· Manage a computer systems validation project
· Use computer systems validation procedures within your organization
· Implement quality and risk procedures into computer systems used in your organization

Target Audience:
· Computer system users

· Auditors
· Quality assurance professionals
· Regulatory affairs professionals
· Information technology professionals