Equivalence of Complex Drug Products: Scientific and Regulatory Challenges

This convening, on November 9, 2016, in New York, USA, is co-sponsored by EUFEPS and aims to identify the best approaches for complex drug development and regulation, to outline outstanding challenges in the assessment of complex drug equivalence and consequences for interchangeability of products, to address whether the regulatory approaches for biosimilars should be used as models for other complex drugs, and to clarify differences and commonalities in the behavior of biological and NBCD families. The end goal is to facilitate the translation of scientific findings into advancements in medicine and to ensure the safety and benefit of patients. Abstract submissions are invited for a poster session. The rise of bio- and nano-technologies has accelerated the development of complex drug products, a class of products that include - but are not limited to - Non Biological Complex Drugs (NBCDs). NBCDs consist of different structures that cannot be fully quantitated and characterised by physico-chemical analytical means. The complex nature of them means that minute variations in the manufacturing process can substantially change the composition of final products, and this poses a challenge for the development of regulatory guidelines. For detailed information consult the website at http://www.nyas.org/Events/Detail.aspx?cid=07082904-d593-4f0e-ada7-446ec8e7444b