2nd Turkish Interactive Workshop on REGULATORY ASSESSMENT OF BIOSIMILARS 2019

24 September 2019, Ankara, Turkey

GaBI organized the 2nd Turkish Interactive Workshop on REGULATORY ASSESSMENT OF BIOSIMILARS on 24 September 2019 in Ankara, Turkey in collaboration with the Turkish Medicines and Medical Devices Agency (TİTCK), Ministry of Health Turkey.

2nd Turkish Interactive Workshop on REGULATORY ASSESSMENT OF BIOSIMILARS is an interactive workshop on the regulation, approval and use of biosimilars for regulators, academics, scientists, medical specialists who are key opinion leaders, pharmacologists and pharmacists (clinical, hospital) and payers from Turkey, to share knowledge and exchange information with experts from Asia, Europe, Turkey and the US. Seventy-seven participants, speakers included, attended the workshop.

This 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, joined together with expert speakers of this educational workshop to engage in active discussion concerning the best practices to regulate and approve biosimilars with a focus on data transparency and labelling, the similarities and differences of the European and Turkish biosimilars regulatory framework, the importance of pharmacovigilance and post-approval traceability of biologicals to ensure patient safety, and to identify future educational needs.

This workshop focuses on regulatory standards/assessment, non-comparable biopharmaceuticals, immunogenicity, switching and pharmacovigilance of biologicals/biosimilars.

Case study on an oncology monoclonal antibody with three scenarios on structure–function importance of biological medicines was discussed in the workshop.

A meeting report of this workshop will be published in GaBI Journal.

You can download the speakers’ presentations of this educational workshop:

Regulatory approval of biosimilars in Turkey: labelling and transparency

Regulatory aspects of biosimilars in the EU

Regulatory assessment of approved rDNA-derived biotherapeutics

How to handle the pre-existing non-comparable biopharmaceuticals licensed prior to the biosimilar approval pathway: experience from Thailand

Biologicals, including biosimilars – the importance of structure and function

Immunogenicity assessment of biotherapeutics: the EU perspective

Biosimilars: pharmacovigilance challenges with multisource biologics

An update on biosimilars and switching experience – the clinical perspective

Source URL: https://gabi-journal.net/about-gabi/educational-workshops/2nd-turkish-interactive-workshop-on-regulatory-assessment-of-biosimilars-2019