Abstracto

Effective regulatory information management

Bobby George

 Regulatory departments are continually being asked to do more with less. In addition, regulatory authorities are increasing the scrutiny related to patient safety and compliance. As regulatory departments are challenged to develop both domestic and global regulatory strategies, coupled with the corporate desire to launch in products in the markets early, the need to understand the regulatory requirements for filing, timelines, what products are approved in which markets is becoming a critical regulatory need for both industry and regulators. Effective regulatory information management processes with appropriate tools are needed to ensure the organization remains compliant with its product registrations. CamBioTec, a Canadian-Latin American Network promoting the safe and effective use of agricultural and environmental biotechnology, undertook an analysis of the current capacities of Argentina