23 June 2019, Penang, Malaysia
GaBI organized the 2nd ASEAN Educational Workshop on REGULATORY CONSIDERATIONS FOR BIOSIMILARS on 23 June 2019 in Penang, Malaysia in collaboration with the ACCSQ-PPWG (ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group).
The 2nd ASEAN Educational Workshop on REGULATORY CONSIDERATIONS FOR BIOSIMILARS is an interactive workshop on quality assessment and regulatory approval of biosimilars for regulators who are key representatives from ACCSQ–PPWG of ASEAN Member States: Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, together with academics, medical practitioners/specialists, pharmacists and procurement specialist, to share knowledge and exchange information with experts from Asia, Canada, Europe and the US. Sixty-one 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 ASEAN Member States who deal with biologicals and biosimilars joined together with expert speakers of this educational workshop to engage in active discussion concerning the importance of quality by design, the significance of regulatory practices to improve pharmacovigilance or post-approval traceability of biotherapeutics to ensure patient safety, and to identify future educational needs.
The workshop focuses on standards and stepwise approach of quality assessment of biologicals/biosimilars, structure–function relationship of biological medicines, analytical comparability, non-clinical and clinical studies of biosimilars, extrapolation and interchangeability, switching, as well as post-marketing pharmacovigilance practices of biotherapeutics.
Case study on an oncology monoclonal antibody with three scenarios on structure–function importance of biological medicines was discussed in the workshop.
You can download the speakers’ presentations of this educational workshop:
Biosimilar regulatory development in the EU – a stepwise approach
Biologicals and biosimilars – the importance of structure and function
Quality by Design (QbD) in process development of therapeutic product
Canada’s approach to non-clinical and clinical assessment of biosimilars
Current regulatory strategies: extrapolation and interchangeability
Interchangeability: US Perspective
An update on biosimilars and switching experience – the clinical perspective
Pharmacovigilance of biotherapeutics
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