First Turkish Interactive Workshop on Regulation and Approval of Similar Biotherapeutic Products/Biosimilars 2016

2 and 3 March 2016, Ankara, Turkey

GaBI organized the First Turkish Interactive Workshop on Regulation and Approval of Similar Biotherapeutic Products/Biosimilars on 2 and 3 March 2016, Ankara, Turkey, in collaboration with the Hacettepe University and the Faculty of Pharmacy.

The First Turkish Interactive Workshop on Regulation and Approval of Similar Biotherapeutic Products (SBPs)/Biosimilars is an interactive workshop for regulators, academics and medical practitioners/specialists (oncologist and haematologists who are key opinion leaders) from Turkey to discuss and exchange information with experts from Germany, Turkey, the UK and the US. Sixty-eight participants, speakers included, attended the workshop.

The educational workshop intends to raise awareness of the potential differences in quality as well as therapeutic and immunological (immunogenicity) effects of biologicals. Representatives from regulatory authorities, academia and medical specialists, who deal with biological and SBPs, joined together with expert speakers of this educational workshop to engage in active discussion amongst various stakeholders concerning the areas of consensus, uncertainty or disagreement concerning the regulation and approval of SBPs, the regulatory assessment of already approved rDNA-derived biotherapeutics, the possible benefits of having distinguishable names for biological products, and to identify the educational needs of various stakeholders.

The workshop focuses on structure–function of biological medicines.  Two case studies were discussed in the workshop.

meeting report of this workshop has been published in GaBI Journal.

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

Current regulatory approval standard and practice on biosimilars in Turkey – Clinician’s Perspective

Regulatory assessment of already approved rDNA-derived biotherapeutics

Introduction to a global view of biologicals, biosimilars and non-originator (non-comparable) biologicals and selection of reference products

Regulatory frameworks for biosimilars: WHO and other perspectives

Biologicals and biosimilars – the complexity of structure and function

Current regulatory approval standard and practice on biosimilars – Turkey

The challenges of nomenclature – INN, biosimilars and biological qualifiers

Contact us for further information.

Last update: 2017-08-28 Go Back Print

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