Regulatory Sciences

Focus Group on BCS and Biowaivers  | Focus Group on Dissolution/In Vitro Drug Release

Chair: Dr Vinod Shah (USA)

Vice-Chairs: Dr Rogerio Gaspar (Portugal) & Dr Oliver Hu (China Taiwan)

FIP/BPS/SIG Regulatory Sciences

The BPS Special Interest Groups serve the distinct needs of those involved in very specific and dedicated branches of the pharmaceutical sciences.  Through their network and initiatives, global networks of specialists are established, fostering communication and the sharing of knowledge within and between the pharmaceutical scientists and pharmaceutical practitioners over the world.  The SIGs aim is to advance and shape the pharmaceutical sciences in the future, to provide modern medicines to the patient worldwide.

The SIG on Regulatory Sciences have a broad scientific scope and it encompass  eight Focus Groups, namely Dissolution/In vitro release; Bioequivalence; BCS and Biowaivers; Biosimilars; Harmonization; Advanced therapies; and Falsified medicines.  The SIG on Regulatory Sciences plan to achieve their objectives and goals by populating various Focus Groups with global members, hold regular conference calls, convene face-to-face meetings, and plan and implement the actions.  The major activities of these focus groups is to address global issues in these areas; organize and participate in national, regional and international professional conferences, develop position papers and publish in referred journals; develop and publish special BCS monographs  that can be used  to facilitate biowaivers; conduct educational regulatory workshops in developing countries; attempt and facilitate global harmonization in certain regulatory areas; be in the forefront at cutting edge science;; and overall be responsive in the field of Pharmaceutical Sciences.