The International Symposium on Scientific and Regulatory Advances in Complex Drugs is organized in Budapest, Hungary, October 27-28, 2014 as a follow-up of very successful series of Bioequivalence Workshops in Hungary. 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 and future symposium is to bring the scientific advances and regulatory challenges for generic equivalence of the complex dosage forms.
The symposium will focus on biological and non-biological complex drugs. These complex drugs require a paradigm shift for regulatory approval compared to the requirements for small molecules. These complex drugs are difficult to characterize it fully and in many instances the manufacturing process is the product itself. The symposium will discuss NBCDs, what it is and why are they different, scientific and regulatory advances in bioanalytical methodologies to characterize these complex drugs and nanoparticles. The symposium will provide challenges in bioequivalence evaluation of NBCDs like iron sucrose complex, glatiramoids, and liposome.
The bioequivalence evaluation for complex dosage forms such as highly variable drugs, narrow therapeutic index drugs, orally administered non-absorbed drugs, inhalation drug products such as MDI and DPI and topical drugs require different approaches and considerations, and will also be discussed at the symposium.
With the advancing field of pharmaceutical science, the pharmaceutical industry and CROs also face new challenges, and these will also be discussed. To help young research scientists participate in the international symposium, posters are welcome. At the end of each session, a panel discussion will be held to discuss various viewpoints. The symposium will also provide ample opportunities for the participants to interact with international speakers on different topics. Prominent representatives of pharmaceutical authorities invited from several continents to contribute to the scientific program. In addition to the keynote speakers as a novelty of this symposium poster presentations are also welcome.
The symposium will end with introductory ceremony of the book of “History of Hungarian Bioequivalence Workshops”.
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.
|Prof. Imre Klebovich||Prof. Vinod P. Shah|
Co-Chairs of the Workshop