AAPS/CRS Workshop on Development and Regulatory Challenges
for Controlled Release Formulations

This workshop is being held in conjunction with the
2009 AAPS Annual Meeting and Exposition.

Goals

The workshop will include a combination of U.S. Food and Drug Administration (FDA) and European regulatory perspectives on developing controlled release formulations. There will be speakers participating in open discussions on newly emerging technologies to help individuals understand the challenges in developing the technology of controlled release formulations as well as the regulatory hurdles that these technologies may face. There will also be speakers who are well known experts talking about mature technologies and the associated developmental and regulatory challenges that were encountered along the road to success. We encourage and expect a lively discussion among the attendees, speakers, and regulatory officials that can shed some light on what is expected when working to get a controlled release product to market.


Educational Objectives

  • To provide an understanding of the developmental and regulatory challenges for controlled release formulations utilizing mature and evolving new technologies in Europe and North America;
  • to provide a venue for young and/or established scientists to informally meet with other scientists and regulatory authorities;
  • to share and discuss fundamental science and experiences that may be of value to individuals dealing with various controlled release (CR) technologies;
  • to gain an understanding of the differences between the regulatory bodies of the E.U. and FDA;
  • to increase an individual's knowledge about a variety of CR technologies that may not be found in the literature through shared experiences and panel discussions; and
  • to apply newly acquired knowledge and a suitable approach to the potential design of the attendees own pharmaceutical products.