10 October 2018, Dubai, United Arab Emirates
GaBI organized the 2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars on 10 October 2018 in Dubai, United Arab Emirates in collaboration with the Ministry of Health and Prevention United Arab Emirates (MOHAP UAE).
The 2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars is an interactive meeting on the regulation, approval and use of biosimilars with a focus on clinical settings, interchangeability/substitution and pharmacovigilance, for regulators, academics, medical practitioners/specialists, pharmacologists and pharmacists (clinical, hospital) and payers from the MENA (Middle East and North Africa) countries covering Bahrain, Egypt, Kuwait, Iran, Jordan, Lebanon, Morocco, Oman, Saudi Arabia, Tunisia and UAE, to share knowledge and exchange information with experts from Canada, Europe, Saudi Arabia, UAE and the US. Fifty-one participants, speakers included, attended the meeting.
This Scientific Meeting offers 10 expert speaker presentations, two panel discussions, five parallel case study workgroup discussions, and one forum discussion. The meeting intends to address the issues of regulatory approval practices/guidelines; concerns and challenges; switching; of biosimilars and post-marketing surveillance of multisource biologicals. Representatives from regulatory authorities, academia and medical specialists from the MENA countries, who deal with biological and biosimilars, joined together with expert speakers of this scientific meeting to engage in active discussion concerning the global development of regulatory framework and barriers; clinical experience on switching; and to identify future educational needs.
The meeting focuses on regulatory; clinical; interchangeability and substitution aspects of biologicals/biosimilars Case study on structure–function of biological medicines was discussed in the meeting.
A meeting report of this meeting has been published in GaBI Journal.
You can download the speakers’ presentations of this educational meeting:
Regulatory Standards and Practices on Biosimilars in UAE: Safety and Efficacy
Regulation of biosimilars in the EU – immunogenicity
Biosimilars regulatory considerations in Saudi Arabia
Biosimilars: Canada’s approaches to interchangeability, biosimilarity, extrapolation of indications and uses – a comparison to the US FDA
Principles and challenges related to manufacturing process development and demonstration of analytical comparability for biosimilars
Clinical and non-clinical assessment of biosimilars
Biologicals and biosimilars – the complexity of structure and function
An update on biosimilars – the clinical perspective
Considerations for product specific pharmacovigilance of multisource biologicals
Contact us for further information.