Clinical data management plays a central role in creating the "multi-million dollar clinical database" which is critical for the industry success. In our endeavors to achieve this, we experience ever-increasing complexity, which has to be balanced with our core competencies, consequently adding value to our role. New technologies and changing processes lead to an expansion of the profile and role of data managers. All this is occurring within an advancing regulatory environment.
The development and adoption of global data standards has been a most difficult journey for the biopharmaceutical and allied health industries. Our internal company policies and standards have allowed us to successfully communicate and transmit data internally, but proprietary corporate standards make it difficult, if not impossible, to communicate effectively and efficiently on a global basis. Global drug development demands an integrated infrastructure for the capture, access, and use of clinical data among partners, alliances, customers and regulators. Many hurdles can be overcome with the use of optimized processes, enabling technologies, the requisite business strategies, and the adoption of common global data standards.
In this Workshop, we wish to review the new skills set acquired, the change to existing processes, the direct influence of international regulatory guidelines, and validation methodologies. This will be achieved by presentations fuelled with practical examples, international expert's input and in-depth discussions.
This Workshop aims to create a forum for European, Asian and US Life sciences organizations and academia to interact, exchange, learn and implement the latest advances in Clinical Data Management as per ICH-GCP standards. This Workshop will offer an excellent opportunity for the exchange of ideas and experience on campus between participants and international practitioners and is designed to reinforce the learning from the sessions, tutorials and work on case studies and will address common problems faced in every day situations.
For details regarding registration and accommodation, please contact :
Dr. Indira Ghosh /Guljit Chaudhri
Convenor Bioinformatics Centre,
University of Pune, Pune 411 007.
Fax: +91 20 569 0087
Phone : +91 20 569 0195, 569 2039
Email : Clinic@ibbpune.org
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