Annual Reports

FIP/BPS/SIG Regulatory Sciences

 

FG: BCS (Biopharmaceutics Classification System) and Biowaivers

Chair: Prof. Jennifer Dressman (Germany)


Annual Report 2016


FIP Focus Group Dissolution/Drug Release

The group has 13 members, 6 from industry, 4 from regulatory affiliations, 2 from pharmacopoeial organisations, 1 from academia, 5 having residence in Europe, 7 in the United States, and 1 in Japan. The focus group members have regularly (every 6-8 weeks) teleconferences.

 

  • Biorelevant in vitro performance testing:

The focus group co-organized with DIA a workshop on “Role of Dissolution Testing in Product Design and Control” in Frankfurt in February 2016. The number of registered participants was below expectations until mid of December 2015.  Thus, DIA and FIP announced the cancellation of the workshop.

 

The FIP focus group has developed a new program, where several speakers from overseas have been replaced by European speakers to reduce travel costs. The revised workshop will be co-organized with the International Association for Pharmaceutical Technology (APV) and will take place in Nuremberg on 26th and 27th September 2017.

 

  • Nanomedicines Workshop in Rockville, MD USA

 

The focus group organized in collaboration with USP a Nanotechnology workshop. This will take place in the USP Meetings Center in Rockville (MD, USA) on March 20-22, 2017.

 

  • International Conference “From Science to Guidance and Practice” in Bucharest, Romania, 6th-7th June 2016

 

 The conference was organized by the Romanian Academy - Section of Medical Science, the Romanian Society for Pharmaceutical Science and O. F. System S.R.L. under the auspices of the International Pharmaceutical Federation (FIP). It took place in Bucharest. Vinod Shah was one of the chairmen of the conference. Focus group members were in the scientific programming committee and five members gave presentations. A hands-on-dissolution session was provided in this conference.

 

  • Revision of the FIP guideline for testing of Solid Oral Dosage Forms.

 

The FIP guideline was published 1995. In the meantime, many new developments have taken place, so that the FG continued to work on a revision of the guideline.

 

 

Goals for 2017:

 

  • Finalize the draft version of the updated FIP dissolution guideline on solid oral dosage forms

 

  • Nanomedicines Workshop in Rockville, MD USA, March 20-22, 2017

 

  • FIP-APV Workshop: “Oral Biopharmaceutics Tools: What’s new and what’s coming?” in Nuremberg, Germany, September 26-27, 2017 


 

Annual Reports from previous years:

 

Annual Report 2015

Annual Report 2014

Annual Report 2013

Annual Report 2012

Annual Report 2010

Annual Report 2008-2009