Second Colombian Scientific Meeting on Quality Assessment of Biosimilars/Similar Biotherapeutic Products 2017

15 August 2017, Bogotá, Colombia

GaBI organized the Second Colombian Scientific Meeting on Quality Assessment of Biosimilars/Similar Biotherapeutic Products on 15 August 2017, Bogotá, Colombia in collaboration with Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).

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 meeting will be published in GaBI Journal.

You can download the speakers’ presentations of this scientific meeting:

Welcoming remarks by INVIMA

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

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Last update: 2017-11-09 Go Back Print

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