Deadlines
Platinum sponsors
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Akkreditált Továbbképzési Kreditpont szerzési lehetőség:
A Semmelweis Egyetem Továbbképzési Központja gyógyszerészek és orvosok részére a GYOFTEX és OFTEX Portálokon akkreditálta a BEW 2014 Workshop-ot az alábbi kódokkal:
SE-GYTK/2014.I./00027,
illetve SE-TK/2014.I./00432.
Megszerezhető: „Minősített szabadon választható" típusú továbbképzési pontszám 25.
Továbbképzési pont igazolás kérése a Regisztrációs Asztalnál!
Preface
The 4 International Regulatory Workshop on A to Z on Bioequivalence, Bioanalysis, Dissolution and Biosimilarity (BEW 2014) is organized again in Budapest, 19-21 May, 2014, in the main Ceremonial Hall of the Hungarian Academy of Sciences (HAS), after a range of internationally acknowledged and highly successful series held in 2006, 2010 and 2012. The history of bioequivalence workshop started in 2001 in Budapest with 120 participants, this rapidly got extended internationally due to the excellent speakers, relevant topics and the wonderful milieu of the HAS building hosting the event. In 2012 we welcomed 280 participants from 38 countries of 5 continents (www.bew2012.hu). Altogether the BEW 2014 will be the fifth meeting of bioequivalence in Budapest, Hungary.
The International Regulatory Workshop on Bioequivalence, Bioanalysis, Dissolution and Biosimilarity is designed to provide a look into the future of drug regulations. The workshop will discuss the challenges for bioequivalence of certain dosage forms, the concept of valueadded generics, the strategies in new and generic drug development, and novel drug delivery systems. The meeting will focus also on bioanalytical regulations, trends of bioanalysis and dissolution performance standards. Regulatory standards are developed to assure that the drug products are safe and effective and quality drug products are produced and marketed. The regulatory standards have undergone rapid and significant changes since the beginning of this century. Several factors have been responsible for this; the introduction of the concept of Biopharmaceutics Classification System (BCS), its regulatory acceptance and industry implementation; increased knowledge of formulation science and widening of biowaiver based on scientific principles without sacrificing the quality of the drug product. Biotech products and biosimilar products are the future wave of drug products, they are coming! The regulatory authorities try to follow the gold standards developed by FDA, EMA and other authorities.
We anticipate of more than 300 scientists from 40 countries around the globe. It is our pleasure to welcome these scientists and provide them an opportunity to discuss challenging topics, to exchange ideas and to learn. During the three days new and returning professionals will come together at one of the most dynamic and enlightening workshops of bioequivalence experts.
The venue of the Workshop, the home of the Hungarian Academy of Sciences, is one of the most distinguished institutions of the 1100-year old Hungary, which will certainly assure the environment where personal contacts can develop in a friendly atmosphere. We wish all participants an enriching stay benefiting fully from both the beautiful milieu and the exciting science that will be presented at our workshop in Budapest, Hungary.
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| Prof. Imre Klebovich | Prof. Vinod P. Shah | |
| Co-Chairs of the Workshop | ||