Evolving the regulatory review process: What are the features that enable a transparent, timely, predictable and good quality review?
6-7th December 2011, Kuala Lumpur, Malaysia
This workshop was held to bring together agencies and companies to identify and discuss the features of an evolving, globally consistent review process that enable the transparent, timely, predictable and good-quality evaluation of new medicines.
Workshop objectives
- Review approval process and practices that can enable as well as hinder the review of new medicines.
- Identify practices and processes for companies and agencies that underpin a transparent, timely, predictable and good-quality review of new medicines.
- Discuss and make recommendations on the key practices and processes that should be considered or adopted as enablers for an evolving review process in the 21st century.