One day Seminar on Bioequivalence

Bioequivalence Studies are a commonly accepted method to demonstrate the therapeutic equivalence between two competing drugs, and form an essential part of the drug registration dossier. Using bioequivalence as a tool to introduce a new generic drug into the market can lead to significant reductions in both the time and costs involved, with the result that the design, performance and evaluation of the related bioequivalence studies have become critical in the drug development process in the pharmaceutical industry. The one day interactive Seminar on Bioequivalence being offered by AIPS will lead to an understanding of the planning, conducting, analyzing and reporting of BE Studies, and will be suitable for professionals in the drug development R&D, regulatory, clinical, medical etc functions.

e-mail : info@aips.ac.in

International Conference on Clinical Trials

Clinical research is an indispensable phase in drug development process to evaluate the efficiency and safety of drug. The process is highly specialized and involves huge investments to introduce new drug capable of curing the ailments.Indian CRO industry is competitive enough to conduct trials to meet the global standards. It is felt that there should be robustness in the IRB and regulatory mechanism so that the clinical trial data generated in India is well accepted globally.

Objectives:

•To create a platform for deliberation on creating conducive regulatory for clinical research to meet global standards.

•To showcase the competitiveness of Indian Clinical Research industry to the International stakeholders and also to facilitate meaningful interactions for possible joint ventures. Key learnings

•Learning of grounding economic and operational realities in conducting international trials. •Creation of working environment that is flexible enough to deal with the regulatory requirements.

•Best practices in global recruitment strategy and how best they can be applied in different regions.

Start Date: Nov 19, 2010, End Date: Nov 20, 2010
Venue: Intercontinental The Lalit Mumbai, Magestic Hall, Sahar Airport Road, Andheri (East), Mumbai Maharashtra India

Contacts :
Ravikiran Veligeti [Executive Officer ]
Confederation of Indian Industry
CII Knowledge & Innovation Initiatives
3rd Floor, IGSSS Building
28, Instutional Area
Lodi Road
New Delhi-110003
Delhi India
Phone : 91-11-45772019
Fax :91-11-45772014
Email : ravikiran.v@cii.in