15 November 2016, Madrid, Spain
GaBI organized the ROUNDTABLE ON BIOSIMILARS – Pharmacovigilance, Traceability, Immunogenicity on 15 November 2016 in 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.
A 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.