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Showing posts with label Clinical trials. Show all posts
Showing posts with label Clinical trials. Show all posts
Wednesday, October 16, 2013
DIA EuroMeeting 2014 Advance Programme now available ~ March 2014 in Vienna
Tuesday, August 27, 2013
The Electronic Trial Master File: So Much More than Just a Secure Document Repository
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Webinar
The Electronic Trial Master File: So Much More than Just
a Secure Document Repository
September 17 | 1:00-2:30 PM ET
Brought to you by DIA in cooperation with NextDocs
Implementing an electronic Trial Master File (eTMF) is becoming a standard business model for the clinical industry. The benefits of moving to an eTMF have been well documented, e.g. increased TMF quality, efficiency, and access to all stakeholders. However, there are additional benefits when considering the move to an eTMF, such asthe benefits gained from leveraging the data within the eTMF.
This FREE webinar will demonstrate how to leverage data to maximize the potential of an eTMF. Presenters will include Sharon Ames, Enterprise Program Director at NextDocs Corporation, and Gabor Fari, Director of Life Sciences Solutions at Microsoft Corporation.
September 17 | 1:00-2:30 PM ET
Brought to you by DIA in cooperation with NextDocs
Implementing an electronic Trial Master File (eTMF) is becoming a standard business model for the clinical industry. The benefits of moving to an eTMF have been well documented, e.g. increased TMF quality, efficiency, and access to all stakeholders. However, there are additional benefits when considering the move to an eTMF, such asthe benefits gained from leveraging the data within the eTMF.
This FREE webinar will demonstrate how to leverage data to maximize the potential of an eTMF. Presenters will include Sharon Ames, Enterprise Program Director at NextDocs Corporation, and Gabor Fari, Director of Life Sciences Solutions at Microsoft Corporation.
Featured topics:
- Using eTMF Data to Define and Measure Key Performance
Indicators and Operational Metrics
- Search vs. Findability – Obtaining Quick and Thorough
Query Results
- Using Interoperability and Standards for Streamlining
the Clinical Trial Process
- Ensuring the Availability of Data through Recommended
and Mandatory Metadata
Who Should Attend? Professionals involved in:
- Coordinating and Managing Clinical Trial Operations for
Drug Development in Sponsor or CRO Organizations
- Optimizing Clinical Trial Business Processes
- Administering and Reconciling TMF Records
- Overseeing Regulatory Compliance and Audit Readiness
for Clinical Trials
- Maintaining IT Infrastructure for Clinical Trials
Thursday, March 14, 2013
Indian Supreme Court, Clinical trials, and Pharma growth
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- Indian court: No need for vegetarian/non-vegetarian labels
The Indian Supreme Count rejected a lower-court ruling requiring "V" and "NV" labels identifying drugs and cosmetics as either vegetarian or non-vegetarian in origin. In opposing the regulation, the government noted the variability in individual food habits, including broad differences even among vegetarians concerning which foods are acceptable and which are not. The Economic Times (India)(3/12)
- Deaths in Indian clinical trials result in few payments
While 2,868 deaths were reported during clinical trials from 2005 to 2012, the Indian government found only 89 to be directly attributable to the trials. To date, compensation has been paid in only 45 cases. The government has established four committees to monitor the fast-growing growing clinical-trial industry in India, mandating strict requirements for reporting adverse events, including deaths, according to the Ministry of Health and Family Welfare. Business Standard (India)(3/13)
- To grow, Indian pharma must embrace innovation, technology
Indian drug companies must focus on new technologies, including development of "super-generics," in order to grow and flourish, said Andrew Barrett, director of medical technology in India at Cambridge Consultants. "[T]he required investments can be recouped because medical products have long lifecycles," he added. Other experts at a Mumbai conference noted that the biggest growth opportunities will come from innovations to differentiate products, because the number of expiring drug patents has peaked, and other countries are offering greater competition for low-cost generics. PharmaTimes (U.K.)(3/13)
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Friday, February 1, 2013
Legal / Transparency Risk Assessment learning opportunities at EuroMeeting2013
Theme 03 - Legal/Transparency-Risk Assessment (22)
Development of Medicinal Products for Paediatric, Elderly and other sessions at EuroMeeting2013 4-6 March in Amsterdam
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other (7)
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