Invited Speaker

Pre-Market Evaluation and Approval of New Antibiotics in Today’s Climate - A Canadian Perspective
Vinay Thatte
Malaysia

The development and spread of resistance to antibiotics has increased over last several years.At the same time the development of newer antibiotics has significantly decreased. Currently only a handful of pharmaceutical companies are involved in development of antibiotics or extending the use of available antibiotics by modifying their use pattern. Among other reasons cited for this drop in development are changes in regulations requiring larger clinical trials and meeting the requirements of different regulatory agencies prior to marketing the drug. This presentation will provide the regulatory requirements for a new drug submission, describe the processes involved in the data evaluation prior to obtaining market authorization and provide the current trends in development and marketing of new drugs from a Canadian perspective.