Preface

The 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non – Biological Complex Drugs: A to Z in Bioequivalence (3rd SRACD) is organized in Budapest, Hungary, November 12 – 14, 2018 as a follow-up of a successful series of Bioequivalence Workshops (BEW series) and two SRACD in 2014 and 2016 which were the first in a series of Symposia in Europe in the field of Complex Drugs. As the science and technologies are advancing, the pharmaceutical world is entering into more complex drug delivery systems and dosage forms. The aim of this symposium is to bring the scientific advances and regulatory challenges for generic equivalence/biosimilarity of complex dosage forms.

The symposium will address major regulatory aspects of biological and non-biological complex drugs (NBCDs) and the paradigm shift compared to the requirements for fully characterized small molecular drugs and the established formulations. The symposium will also discuss advances in bioanalytical methodologies to characterize these complex drugs including nanostructures affecting biodistribution. Case studies will be presented to specifically focus on the bioequivalence evaluation of complex drugs.

The symposium will also provide an update on harmonization attempts for bioequivalence of small molecular drugs with an insight into drug dissolution/drug release and bioanalytical advances, including the use of Mass Spectrometry (MS), as a most progressively developing (bio-)analytical technics today.

Panel discussions will be held to discuss hot topics with moderators, invited experts and session speakers. The symposium will also offer ample opportunities for the participants to interact with not only international speakers on different topics, but with the representatives of CROs and exhibitors of different laboratory equipment services. Prominent representatives of pharmaceutical authorities are invited to contribute to the scientific program.

In order to enhance the participation of young research scientists in the international symposium, posters are welcome and will be presented in an attractive format. Selected poster authors shall provide five minute highlight presentations in plenary sessions.

Together with exciting advanced science insight, the meeting venue will provide all participants an enriching stay in the beautiful area of the Margaret Island and the special atmosphere of the UNESCO protected Music Fountain and Water Tower in Budapest.

We are delighted to welcome you to one of the most prestigious International Pharmaceutical Research and Regulatory Science event in Budapest.

 

Imre KlebovichImre KlebovichProf. Imre
Klebovich
Vinod ShahVinod ShahProf. Vinod P.
Shah
SMuhlebachStefan MühlebachProf. Stefan Mühlebach



Co-Chairs of the Symposium