Biotechnology and Nonclinical Laboratory Safety Assessment  
Click on the session title for a complete description.
Day Session Link
Monday Hot Topics in Biotechnology
Monday Immunogenicity: Strategies for Testing and Evaluation
Monday Regulatory Methods to Facilitate the Approval of Biological Products to Address Pandemic Influenza
Tuesday Adding Value to Early-stage Biotechnology Product Development
Tuesday Countering Bioterrorism: Regulatory Methods Designed to Speed the Availability of Biological Products
Tuesday Follow-on Biologics: Ensuring Quality, Efficacy and Safety
Tuesday Regulatory Challenges Related to the Development of Second Generation Therapeutic Proteins
Tuesday Evaluation of the Safety of Pharmaceuticals in the Environment (Water)
Tuesday First-in-Human Studies
Wednesday Developing Safe and Effective Biological Medicines: Phase 2 and Beyond
Wednesday Managing First-in-man Studies
Wednesday Opportunities for the Treatment of Rare Diseases
Wednesday RNAi Therapeutics: From Concept to Implementation
Wednesday New Approaches to Toxicity Testing to Support Pharmaceutical Development - Part 1 of 2: New Endpoints
Wednesday New Approaches to Toxicity Testing to Support Pharmaceutical Development - Part 2 of 2:  New Models
Wednesday Potentially Genotoxic Impurities, Metabolites and Degradates: The Need for an Integrated Approach to Safety Assessment
Wednesday Use and Usefulness of Juvenile Animal Studies in the Development of Pediatric Drugs
Thursday Preclinical Safety Evaluation of Novel Adjuvants and Vaccines
Thursday Recent Advancement of Emerging Technology in the Asia-Pacific Region
Thursday Updating ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals
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