ROUNDTABLE ON BIOSIMILARS – Pharmacovigilance, Traceability, Immunogenicity 2016

15 November 2016, Madrid, Spain

GaBI organized the ROUNDTABLE ON BIOSIMILARS – Pharmacovigilance, Traceability, Immunogenicity on 15 November 2016, Madrid, Spain in collaboration with the Universidad de Alcalá.

The Roundtable on Biosimilars is an interactive meeting with the participation of academics, regulators, medical practitioners/specialists (oncologists and rheumatologists who are key opinion leaders) and pharmacologists/ pharmacists from Spain, to discuss and exchange information with experts from The Netherlands, Spain and the UK on biosimilars focusing on the key issues of pharmacovigilance, traceability, immunogenicity.  Thirty-six participants, speakers included, attended the meeting.

The meeting focused on practical challenges in the implementation of robust pharmacovigilance systems, how to establish pharmacovigilance schemes to enhance traceability and post-marketing surveillance of biologicals including biosimilars, and to promote a dialogue between clinicians, pharmacologists, pharmacists, academics and regulators.

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

You can download the speakers’ presentations of this roundtable meeting:

Welcome, meeting objectives and introduction to biosimilars

EMA approval requirements on biosimilars: clinical aspects

Evaluation of immunogenicity of biosimilars

Understanding pharmacovigilance for biologicals and the current challenges in Spain

Current challenges in traceability of biologicals – a case study from the Netherlands

Pharmacologist perspective – Considerations of the Spanish Society of Pharmacology on pharmacovigilance, traceability and immunogenicity of biosimilars from the biomedical perspective

Oncologist perspective – Antibody biosimilars in oncology: an analytical to clinical perspective

Rheumatologist perspective – Position statement of the Spanish Society of Rheumatology on biosimilar drugs. Clinical vision

Pharmacist perspective – Biosimilars: something more than clinical evidence

Contact us for further information.

Last update: 2018-01-09 Go Back Print

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