0 days
before the conference

Deadlines

April 20, 2012
Early registration
(deadline extended)
April 30, 2012
Hotel reservation
April 30, 2012
Cancellation without penalty

 

Preface

 

The 3rd International Regulatory Workshop on A to Z on Bioequivalence Bioanalysis, Dissolution and Biosimilarity will be held in Budapest, at the Hungarian Academy of Sciences (HAS), on June 4-6, 2012. This special event offers an extraordinary occasion for the participants to meet leading scientists and learn of new directions in drug dissolution, bioequivalence studies and regulations, providing a neutral platform to discuss these issues. This Workshop has become the most prestigious meeting of bioequivalence and related subjects in Europe that is why we intend to organize three-day program in the Ceremonial Hall of HAS.

The 3rd International Regulatory Workshop on A to Z 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 value-added generics, the strategies in generic drug development, and novel drug delivery systems. The meeting will focus also on bioanalytical regulations as well as on trends of bioanalysis. Regulatory standards are developed to ensure that the drug products are safe and effective and that drug products of high quality 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 its implementation by industry. Moreover, increased knowledge of formulation science and the widening of biowaiver-based scientific principles have assisted the development of effective drug products without sacrificing their quality. Biotech products and biosimilar products are the future wave of drug development, they are coming! Gold standards have been developed by regulatory authorities in the US, the European Union and other countries.

We anticipate of more than 300 scientists from 30 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 was built in 1865 in neo-renaissance style. The HAS itself was founded in 1825 and has served as one of the most distinguished institutions in Hungary.

We hope you will find the Workshop a stimulating opportunity for meeting colleagues and friends, old and new, and that you will return home with pleasant memories of the scientific and social events as well as of Hungary.

 

Imre Klebovich Vinod Shah
Imre Klebovich Vinod Shah
Prof. Imre Klebovich Prof. Vinod P. Shah
Co-Chairs of the Workshop