23 July 2017, Bangkok, Thailand
GaBI organized the First ASEAN Educational Workshop on Regulation and Approval of Biosimilars/Similar Biotherapeutic Products on 23 July 2017, Bangkok, Thailand in collaboration with the ASEAN (Association of Southeast Asian Nations) ACCSQ-PPWG.
The First ASEAN Educational Workshop on Regulation and Approval of Biosimilars/Similar Biotherapeutic Products is an interactive workshop on the regulation and approval of biosimilars for regulators who are key representatives from ACCSQ–PPWG of ASEAN Member States: Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam; together with academics, medical practitioners/specialists, pharmacists and procurement specialist from Singapore and Thailand to discuss and exchange information with experts from Asia, Europe and the US. Forty-three participants, speakers included, attended the workshop.
The educational workshop intends to address the issue of potential differences in quality as well as therapeutic and immunological (immunogenicity) effects of biologicals. Representatives from regulatory authorities, academia and medical specialists from ASEAN Member States, who deal with biological and biosimilars, joined together with expert speakers of this educational workshop to engage in active discussion concerning principles and challenges related to manufacturing process development for biosimilars, clinician’s experience of biocopy EPO, regulatory experience of re-evaluating erythropoietin, and to identify future educational needs.
The workshop focuses on structure–function of biological medicines. One case study 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:
Contact us for further information.