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

Some years ago, 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 needs of those involved in branches of the pharmaceutical sciences with regulatory impact.  Through their initiatives, global networks of specialists are established, fostering communication andsharing of knowledge within and between pharmaceutical scientists and pharmaceutical practitioners over the world.  The SIG’s aim is to advance and shape the pharmaceutical sciences of the future, and to provide modern medicines to patients worldwide.

The SIG Regulatory Sciences has a broad scientific scope, encompassing four Focus Groups:

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

The SIG Regulatory Sciences plans to achieve its objectives and goals by populating various Focus Groups with global members, holding regular conference calls, convening face-to-face meetings, and planning and implementing its activities. 

The major activities of the four 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;
- 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.