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Conference Directory
International Conference and Exhibition on Biowaivers and Biosimilars
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Venue Name: Hilton San Antonio Airport
Country: United States of America
City: San Antonio
State: Texas
Number of Attendees: 101-500
Webinar or Virtual Event: No
Keywords: Biosimilars, Therapeutic Proteins, Recombinant Vaccines, Clinical issues, Patent issues, Biowaiver Monographs, Biosimilar Monoclonal antibodies, Biosimilars Regulatory approval , Biosimilars Marketing , Biowaivers, Waiver for Bioequivalence studies, Biosimilar Drugs, Follow-on Biologic, Bio-pharmaceutical products, Biosimilars therapeutics, Biosimilars safety, Drug delivery, Drug interactions, Drug metabolism, BCS, Biomedical informatics, Reference standards, Biosimilars peptides, IVIVC, FDA, EU regulation, Bioequivalence testing, Dissolution testing, Dosage forms, Solid dosage forms, Topical dosage forms Respiratory dosage forms, Transdermal dosage forms, Bioanalytical methods, Pharmaceutics, Pharmacokinetics, Pharmacodynamics, Generic Drug Development, Statistical analysis, Formulation Development, Biowaiver Extensions, Process Validation, Recombinant technology, Antibody engineering, Protein engineering, Pharmacoeconomics, Bioequivalence, Bioavailability, Bioethics, Pharmacovigilance, Quality regulation, Safety regulation, Biosimilars licensing, Immunogenicity, Biotechnology medicinal products, subsequent entry biologics, Biosimilar Erythropoietin, Biosimilars Insulin, Biosimilars Hormones, Biosimilar Interferons, Biomedicine, Cell Biology, Toxicology, Biotechnology, Public health, Drug Permeability, In vitro BCS Biowaivers, Bioequivalence In vitro, Biowaiver assessment, Oral Drug Adsorption, In vitro Assays, Absorption, Solubility, Essential medicines, Low Soluble High Permeable Compound.
Start Date of Conference:: 09-10-2012
End Date of Conference: 09-12-2012
Description of Conference: Biosimilars-2012 is a specially designed cluster conference. The main theme of the conference is “A Synergistic Approach towards Biowaivers and Biosimilars” which covers a wide range of critically important sessions.
Biosimilars-2012 is designed to discuss the development and progress of research in the areas of drug discovery, clinical trials, regulatory and economic considerations towards Biosimilars and waiver for Bioequivalence studies, BCS Biowaiver Studies, Dosage forms, Dissolution Testing and IVIVC.
Important Dates:
Avail the early bird discounts and register on/before April 23, 2012.
Abstract Submission closes on: July 20, 2012
Registration closes on: July 29, 2012
On spot Registration: September 10, 2012
Biosimilars-2012 is comprised of 11 tracks and 63 sessions designed to offer comprehensive sessions that address current issues related to Biowaivers and Biosimilars.
We warmly invite you to attend and submit your abstract to any of the following sessions:
Track 1: Biosimilars: Innovator Pharmaceutical Products
Track 1-1 Biosimilars: An Overview
Track 1-2 Biotechnology Medicinal Products Different from Drugs
Track 1-3 Future of Next Generation Biosimilars
Track 1-4 Challenges Faced in Developing Biosimilars
Track 2: Commercialization or Globalization of Biosimilars
Track 2-1 Biosimilar Drugs
Track 2-2 Economic Aspect towards Biosimilars
Track 2-3 Biosimilars in Market
Track 2-4 Investment and Returns on Biosimilars
Track 3: Skill Set for Biosimilars Development
Track 3-1 Immunogenicity
Track 3-2 Clinical Development
Track 3-3 Pharmacovigilance
Track 3-4 Product Development Strategies
Track 3-5 Generic Drug Development
Track 3-6 Biomedical Informatics
Track 4: Biosimilars: Regulatory Approach
Track 4-1 Licensing of Biosimilars
Track 4-2 EU Biosimilars Regulation
Track 4-3 Patent Issues
Track 4-4 FDA's view on Biosimilars
Track 5: Clinical Studies
Track 5-1 Clinical Trials
Track 5-2 Risk Management and Quality Affairs
Track 5-3 Transgenic animals
Track 5-4 Targeted Cell line Development
Track 5-5 Clinical PK/PD Studies
Track 5-6 Toxicology
Track 5-7 Aspects of Genotoxicity Tests
Track 6: Biosimilars Therapeutics
Track 6-1 Recombinant Blood Products
Track 6-2 Recombinant Vaccines
Track 6-3 Growth Hormones
Track 6-4 Biosimilar Peptides
Track 6-5 Recombinant Therapeutic Proteins
Track 6-6 Biosimilars for Cancer
Track 6-7 Biosimilars Monoclonal Antibodies
Track 6-8 Biosimilar Interferon
Track 7: Plant Produced Biosimilar Products
Track 7-1 Transgenic Plants
Track 7-2 Post Translational Genetics
Track 7-3 Fermentation Culture
Track 7-4 Product Safety & Efficacy
Track 7-5 Molecular Farming
Track 8: Biowaivers
Track 8-1 FDA Approach to Bioequivalence Testing
Track 8-2 Choice of Reference Product for Bioequivalence Testing
Track 8-3 Safety and Quality Regulation for Drug Development
Track 8-4 WHO Considerations for Bioequivalence and Dissolution
Testing
Track 8-5 Process Validation for Drugs and Biologics
Track 9: BCS & IVIVC Based Biowaivers
Track 9-1 BCS Biowaiver Studies
Track 9-2 Waiver for In vivo Bioavailability or Bioequivalence
Track 9-3 BCS: A Strategic Tool for Classifying Drug Substances
Track 9-4 Consideration of Biowaiver Extensions for BCS Class
III Drugs
Track 9-5 IVIVC Based Biowaivers
Track 9-6 Dissolution Testing in Drug Formulation
Track 9-7 In vitro Preclinical ADME/BCS Testing
Track 9-8 In vitro Drug Product Research
Track 10: Bioequivalence Assessment
Track 10-1 Bioequivalence Testing for Dosage Forms
Track 10-2 Bioequivalence Testing for Topical Dosage Forms
Track 10-3 Bioequivalence Testing for Respiratory Dosage Forms
Track 10-4 Bioequivalence Testing for Transdermal Dosage Forms
Track 10-5 Statistical Analysis for Bioequivalence Testing
Track 11: Analytical Strategies
Track 11-1 Bioanalytical Methods
Track 11-2 Formulation
Track 11-3 Bioassay for Comparability & Potency Testing
Track 11-4 GMP Protein Analysis
Track 11-5 LC/MS analysis for discovery, preclinical and
clinical programs
Track 11-6 Electrophoresis
Track 11-7 Multimodal techniques
Submit your abstract to biosimilars2012@omicsonline.org
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