SIG on Regulatory Sciences

 

Chair: Prof. Jennifer Dressman (Germany)

Chair (Focus Group Dissolution): Dr Horst-Dieter Friedel and Ms Cynthia Brown
Chair (Focus Group Bioavailability and Bioequivalence): Prof. Shinji Yamashita
Chair (Clinical Bridging Studies): Dr Oliver Hu
Chair (Focus Group BCS and Biowaiver): Prof. Jennifer Dressman

Very recently, the Regulatory Sciences lost a great contributor, Dr Dirk Barends. Click here to read a tribute to his work and dedication to such issues via FIP and around the world.

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 4 Focus Groups, namely:

1. Dissolution/In vitro release;
2. BCS and Biowaivers;
3. Bioavailability/Bioequivalence and
4. Clinical Bridging Studies

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.

 

For more information on this SIG, please contact Prof. Dressman at RegulatorySciences@fip.org.