30 April 2019, Bogotá, Colombia
GaBI organized the 3rd Colombian Educational Workshop on REGULATORY ASSESSMENT OF BIOSIMILARS on 30 April 2019 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 3rd Colombian Educational Workshop on REGULATORY ASSESSMENT OF BIOSIMILARS is an interactive workshop for regulators including quality/clinical assessors, licensing regulators, as well as academics and members of the expert advisory committee of INVIMA who are involved in biological/biosimilar medicines evaluation. This workshop provides a forum for regulators, clinicians, pharmacists, academics and medical specialists from Colombia to share knowledge and exchange information with experts from Canada, Colombia, Europe and the US. Eighty-seven participants, speakers included, attended the workshop.
This educational workshop intends to increase the understanding of the concept of stepwise approach and specific quality evaluation elements on comparability and safety aspects of biologicals/biosimilars including immunogenicity effects of biologicals. Representatives from regulatory authorities, academia, healthcare professionals from Colombia who deal with biologicals and biosimilars joined together with expert speakers of this educational workshop to engage in active discussion concerning the importance of pharmacological (PK/PD) and clinical studies, the significance of regulatory practices to improve pharmacovigilance or post-approval traceability of biologicals/biosimilars to ensure patient safety, and to identify future educational needs.
The workshop focuses on standards and stepwise approach of quality and immunogenicity assessment of biologicals/biosimilars, structure–function relationship of biological medicines, switching, pharmacological (PK/PD) and clinical studies of biosimilars, extrapolation of indications, and post-marketing pharmacovigilance practices of biologicals/biosimilars.
Case study on an oncology monoclonal antibody covering the structure–function importance of biological medicines was discussed in the workshop.
A meeting report of this workshop has been published in GaBI Journal.
You can download the speakers’ presentations of this educational workshop:
Colombia’s biological/biosimilar regulation: a year after its implementation
Biosimilar regulation in Colombia: one year later
Quality assessment of biologicals/biosimilars – most relevant quality attributes: case study on monoclonal antibody
Biologicals and biosimilars – the complexity of structure and function
Pharmacological studies (PK/PD) to assess biosimilar medicinal products
Head-to-head clinical studies and biosimilarity studies to assess biosimilar medicinal products
Considerations for product specific pharmacovigilance of multisource biologicals
Immunogenicity studies for assessing biosimilar products
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