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[india-drug] Seminar on Clinical Trials and Clinical Data Management


  • From: priya@vaatsalya.com
  • Date: Thu, 2 Feb 2006 15:09:22 +0530

*Quality & Compliance Assurance : Best Practices & Current **Trends
in Clinical Trials and Clinical Data Management*
-----------------------------------------------

To be organized by Vaatsalya healthcare solutions, Bangalore
(http://www.vaatsalya.com)

Clinical research takes a new dimension in India after the active
involvement of regulatory authorities in recommending effective mechanisms.
Regulatory guidelines in India are now gaining acceptance & visibility after
sustained efforts from the industry leaders. Nevertheless the system
currently under development has to be monitored constantly for compliance.

Developed countries have advanced system and legislation in place; however
compliance monitoring has not gained enough importance in developing
countries. As a consequence, conducting clinical trial by a sponsor and
the public assurance governance by the regulatory authority is difficult.
A few contract research organizations functioning in India have managed
to acquire quality and compliance knowledge from outside India. Obviously
many must be waiting to gain similar level knowledge to stay competitive.

Thus, the program to be organized by Vaatsalya is designed to bring
the industry and the regulatory bodies to present their views relating to quality and compliance.

Vaatsalya healthcare solutions plan to bring together the leaders and
practitioners in the area of clinical research to discuss the quality and compliance issues on design and management of clinical trials. The workshop will be interactive and will have national and international speakers. This interactive program will enable the participants to understand and appreciate the following issues:

- Quality and Compliance Standards
- Quality & Compliance, the Indian Scenario
- Relevant Case Studies,

The program will be most suitable for mid to senior level executives from
the clinical research, pharmaceutical and biotech organizations. In addition
to the talks, three interactive sessions, best approach, regulatory role in
QnC monitoring, building a perfect clinical trial have been organized to
enable the group to look at various issues in greater detail.

*Target Audience*
Internal auditors and CRA's, Expected audience of 50.

*Speakers *
The eminent panel of speakers has been drawn from the industry and the
regulatory authorities.

*Expression of Interest*
In case, you are interested and want to participate in the program, kindly
fill the registration form and e-mail us the details mentioned below to
reach us before 10, February, 2006

Individuals/companies interested to participate in the program can write to
priya@vaatsalya.com

With Regards
Dr B Priya
Head Quality and Compliance Service Group
Vaatsalya Health Care Solutions
Email: priya@vaatsalya.com