EUFEPS Annual Meeting 2018

24-26 May, 2018, Titania Hotel, Athens Oral Drug absorption: Science & Regulation From properties and processes (dissolution, solubility, supersaturation, precipitation, permeability, carriers, IVIVC, BCS, BDDCS, biowaivers) To the classical/ most innovative medicines (minitablets, 3D printing, controlled release, nanoscinece, gene delivery) and their PK - PD evaluation (clinical studies,...

3rd GBHI conference

Scope and aim Assessment of bioequivalence is considered one of the key elements in the development and registration of new medicinal products. In case of generic drugs, it is the essential basis for product approvals worldwide. At the same time, it is obvious that the regulations and jurisdictions still differ to certain extent from country to country and region to region. This does not only...

EUFEPS QbD-PAT Sciences Network new Position Paper

The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD)...

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...

Position Paper on Veterinary Medicines – New EUFEPS Network Initiative

Veterinary medicines account for a substantial portion of the production, sale, and consumption of medicines in Europe, and probably world-wide. This calls our attention to the fact that only healthy farm animals can ensure safe and sufficient livestock products to meet the growing demand for animal protein. Human and veterinary medicine share many common features - expressed and symbolised by...