15 August 2017, Bogotá, Colombia
GaBI organized the Second Colombian Scientific Meeting on Quality Assessment of Biosimilars/Similar Biotherapeutic Products on 15 August 2017 in Bogotá, Colombia in collaboration with Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), the National Food and Drug Surveillance Institute of Colombia.
The Second Colombian Scientific Meeting on Quality Assessment of Biosimilars/Similar Biotherapeutic Products is an interactive meeting on quality assessment of biosimilars for regulators and members of the expert advisory committee of INVIMA as well as academics from Colombia, to discuss and exchange information with experts from Europe and the US. Fifty-two participants, speakers included, attended the meeting.
The Scientific Meeting focused on quality assessment issues of biologicals covering the topics of specifications; comparability in production process; analytical comparability/methods; reference standards and materials; degradation studies; and development/validation of host cell protein assays of biotechnology products/biosimilars. A keynote presentation on the NOR-SWITCH study had been delivered in this meeting.
A meeting report of this roundtable has been published in GaBI Journal.
You can download the speakers’ presentations of this scientific meeting:
Biosimilars regulations in Colombia
Switching from originator product to biosimilars in rheumatology, dermatology and gastroenterology: clinical evidence
Preparation and production of reference standards in support of biotechnology products
Value assignment of International Standards: challenges for potency labelling of biotechnology/biosimilar products
Contact us for further information.