This conference is the biggest of its kind and brings together high level executives to discuss and disseminate aspects of required data disclosure in a time of industry reform.
この度、有害事象報告プロセスのためのクラウド型ソリューション (agReporter Plus™) を国内市場での正式リリースに伴い、下記の要領にて製品発表セミナーを開催する運びとなりましたので、ここにご案内を申し上げます。
当セミナーでは、現役の医師が語る臨床現場での詳細調査協力プロセスの特別基調講演を始め、革新的な有害事象報告プロセスのソリューション製品のご紹介、デモンストレーションによる体感、そしてパートナーであるデロイト トーマツ コンサルティング株式会社による報告業務プロセス改革のための提案等、豊富なトピックで製品ソリューションのご紹介を予定しております。
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【セミナー名】：「agReporter Plus™ 革新的な有害事象報告プロセスセミナー」
・ 革新的な有害事象報告プロセスソリューション「agReporter Plus™」製品のご紹介
♦ 当セミナーのプログラムに関しましては、以下のリンクからご覧ください。 ♦
♦ 参加登録は以下のリンクからお願い致します。 ♦
♦ agReporter Plus™ 製品の概要に関しましては、以下のページからご覧ください。 ♦
Learn how a unified EDC, ePRO and randomization and trial supply management (RTSM) solution can cut costs and speed up clinical development programs.
Building on our clinical data management webinar series last year (EDC, ePRO, and RTSM), kick start the New Year with this informative webinar presented by our clinical subject matter experts Simon Wilson and David Lopez.
This unique, complimentary webcast explores a complete approach to Clinical Data Management that can:
• Achieve instant and full data consolidation with zero effort
• Maximize efficiencies for site drug shipment, trial supply management with full, live drug accountability
• Enable real time data visibility of patient reported outcomes in EDC
Key learning outcomes
In this 45-minute complimentary webinar, learn how having a fully unified solution that has complete flexibility handles clinical data management problems faced today, and has the capability to handle future studies.
• Understand what is meant by unification
• Discover how it can solve the problems faced by CDM teams by looking at its effects on EDC, ePRO, RTSM, and medical coding
• What challenges to expect in 2015
As a Pharma company you must aware of the upcoming IDMP guidelines which will come into force in 2016.
This is however not just a European challenge, the FDA is also working on the adoption of the IDMP and so are the regulators in Japan.
Is your organization ready for IDMP? As a pharmaceutical company you may be tempted to look at IDMP as an additional standard that needs to be complied with, or as an effort requiring additional resources. You may also think that the ownership of IDMP lies with the regulatory function in your organization. While this is true to a certain extent we must remember that the sources of data for IDMP will lie outside and will involve intense collaboration between departments such as regulatory, safety, manufacturing to name a few.
Join us for this webinar on ‘IDMP 101- An overview of IDMP’ and gain insights into
a. The regulatory background
b. The definition of IDMP
c. The key terms within IDMP
d. The Impact on other divisions of your organization
e. IDMP implementation Challenges
f. The Logical approach to IDMP
Webinar: IDMP 101- An overview of IDMP
Date: 19th February 2015
Time: 12.00 PM GMT or 7 AM Eastern
Click the link below to register
Most safety departments are having to deal with a consistent growth in year-to-year case processing volumes. There are generally multiple factors driving this increase in volumes, including sales growth, new product launches, increasing patient support programs, new clinical studies, etc. However, budgets for safety processing do not generally reflect a similar upward trend, as companies continue to cut costs and expect departments to do more with less.
To continue to ensure regulatory reporting compliance, companies have to consider all options to handle this growth in case volumes. These options may span across resourcing strategies, business process reengineering, and enhancements to systems and technology to gain efficiencies in operations. This webinar looks at some of the options over the long term that safety departments and technology providers need to consider to ensure on-going capability to manage the increasing case processing workload.
ArisGlobal presents the IDMP webinar series 2015. These series of webinars are designed to guide you on your journey towards IDMP compliance in 2016.
Join us for our second webinar in this series titled ‘IDMP Deep Dive – Understanding Medicinal Product and Pharmaceutical Product concepts’ and gain insights into:
Definitions, key attributes and examples of core IDMP concepts
• Medicinal Product
• Pharmaceutical Product
• Packaged Medicinal Product
• Manufactured Item
Levels at which IDMP Identifiers are assigned
• Medicinal Product Identifier
• Pharmaceutical Product Set Identifiers
• Packaged Medicinal Product Identifier
• Batch Identifiers
Click the link below to register
In an increasingly global environment, drug safety departments have been making significant investments in implementing common processes and systems to support operations in all regions. This may entail deploying local tracking systems for initial receipt and final submission, integrated with a centralized core case processing system. With the wider user base and generally increasing year-to-year case volumes, the focus of these systems is on efficiencies of single case processing and retrieval. However, there are multiple business needs requiring fast reporting and analysis spanning cumulative safety data. In addition to the basic regulatory need for compilation of periodic safety update report listings, companies need to analyze consolidated processing data across operating units to monitor compliance or look at metrics to effect resource and operational efficiencies. Finally, companies also need a platform for maintaining other available large-pool safety data from external sources to utilize in signal detection and benefit-risk management activities.
This webinar looks at the advantages of implementing an optimized data warehouse platform for safety reporting and analytics that can address these different business needs.
The speed of builds and integrations, and the risks and costs associated with integrations,
have been very discouraging to some users. For a CRO, costly builds and delays in client deliverables make for a difficult sell and a lack of return in business. Attend this special session to listen to Scope explain their struggles with inter-eClinical solution compatibility and how they adopted a solution that overcame these problems.
Attend this 45-minute webinar to understand:
• The problems associated with EDC integration
• Scope’s experience with integrating multiple applications
• The advantages of a unified approach
IIR’s Partnerships in Clinical Trials event is North America’s largest conference serving the
global clinical trials, operations and outsourcing community. ArisGlobal is an exhibitor at this event (Booth 203). Conference web site: http://www.iirusa.com/cropartners/welcome-to-CROs.xml