The 2nd International Symposium on Scientific and Regulatory Advances in Complex Drugs (SRACD 2016) is organized in Budapest, Hungary, October 10-11, 2016 as a follow-up of very successful series of Bioequivalence Workshops (BEW series) and the 1st SRACD in 2014 which was the first Symposium in Europe in the field of Biologicals and 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 discuss the scientific advances and regulatory challenges for generic equivalence of the complex dosage forms.
The symposium will focus on biologicals and non-biological complex drugs (NBCDs). These complex drugs require a paradigm shift for regulatory approval compared to the requirements for small molecules. These complex drugs are difficult to fully characterize and the tight control of the manufacturing process makes the specific product. The symposium will discuss biologicals and NBCDs, what they are and why are they different, scientific and regulatory advances in bioanalytical methodologies to characterize these biologicals, complex drugs and nanoparticles. SRACD 2016 will present similarities between biologicals and NBCDs. It will focus on potential challenges in therapeutic equivalence evaluation of NBCDs like nanomedicines, iron sucrose complexes, glatiramoids, liposomes and complex ophthalmic emulsions.
To help young research scientists participate in the international symposium, posters are welcome. Panel discussions will be held to discuss various viewpoints (two on each day). The symposium will also provide ample opportunities for the participants to interact with international speakers on different topics. Prominent representatives of pharmaceutical authorities are invited from several continents to contribute to the scientific program.
We wish all participants an enriching stay in the beautiful milieu of Margaret Island in Budapest with a special atmosphere of the UNESCO protected Music Fountain and Water Tower and exciting science that will be presented.
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| Prof. Imre Klebovich |
Prof. Daan J. A. Crommelin |
Prof. Stefan Mühlebach |
Prof. Vinod P. Shah |
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Co-Chairs of the Symposium |
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