Bioiberica S.A. has been invited as a speaker at the 5th Workshop on the Characterization of Heparin Products organized by the USP

The
symposium, organized by the United States Pharmacopeia Convention, the National
Institute for Biological Standards and Control (NIBSC) and the European
Directorate for the Quality of Medicines and Healthcare (EDQM, Council of
Europe), is a dialogue forum that brings together Health and Regulatory
Authorities of the main areas, the most important authorities of the academic
world and largest Heparin producers worldwide.

This year
the characterization and standardization of heparin of high and low molecular
weight, its production and supply sources will be discussed.

Other
topics will be the new revision of the USP monograph and the implementation of
new methods of analysis.

A new
section in this event will focus on the imminent implementation of new
regulatory requirements and the challenge that this means. Bioiberica has been
invited to give a talk in this section thanks to its long experience in this field.

Irene
Bartolí (Bioiberica’s DMF Affairs Manager) will explain Bioiberica’s actions to
be constantly at the forefront of the latest updates on the new regulations in
Europe and North America (U.S. FDA and Canada).

Moreover,
the presentation will also deal with the new challenges for Heparin producers due
to the new regulatory requirements focused increasingly on traceability,
characterization of crude material and total process control.