| Click on the session title for a complete description. |
| Day |
Session Link |
| Monday |
Integrated Analyses through a Drug’s Life Cycle: Plan to Think about Safety |
| Monday |
PDUFA IV Commitments on Review and Evaluation of Trademarks (Proprietary Names) and Update on Pilot Program for Evaluation of Proposed Names |
| Monday |
Integrating the Science of Drug Development and Safety into Health-care Professionals' Curriculum |
| Monday |
An Introduction and Discussion of FDAAA, FDA’s New Regulatory Authorities |
| Monday |
Best Practices for Interactions between Industry and FDA (Office of New Drugs/Office of Surveillance and Epidemiology) Considerations during Drug Product Life Cycle on Safety |
| Monday |
Pharmacogenomics in Action: A Practical View of Pharmacogenomic Submissions, FDA Review Process, and Label Revisions |
| Monday |
Proactive FDA Safety Meetings: Anticipating Safety Issues |
| Monday |
2008 Benchmark Survey Results: Project Management in the Pharmaceutical Industry |
| Monday |
Smashing Silos: Bringing Service-oriented Architecture and Data Warehousing to a Pharmaceutical Company Environment |
| Monday |
Planning of Drug Safety Evaluation |
| Monday |
Improving Safety with Every Step: The Patient Perspective |
| Tuesday |
Regulatory Requirements for Natural Health Products/Herbal Medicinal Products in the US and EU |
| Tuesday |
First-in-Human Studies |
| Tuesday |
Pediatric Drug Development: A Global Challenge |
| Tuesday |
Integrated Summaries and Beyond: Be Prepared |
| Tuesday |
Implementing Global Electronic Submissions: The Company and the Regulators Give their Points of View |
| Tuesday |
Regulatory Challenges Related to the Development of Second Generation Therapeutic Proteins |
| Tuesday |
Beyond the QT Interval: Regulatory Perspective on the Use of Surrogates in Pre-market Safety and Risk/Benefit Evaluation |
| Tuesday |
Follow-on Biologics: Ensuring Quality, Efficacy and Safety |
| Tuesday |
Drug Safety Personnel – Qualifications? Further Education? What Are the Basic Requirements and What Is Nice to Have? Where Do Regulators and Industry Find Talent? |
| Tuesday |
Clinical Supplies Management under Uncertainty |
| Tuesday |
Postmarketing Requirements and Commitments (PMRs/PMCs): FDAAA’s Impact and How FDA and Industry Are Addressing the Backlog |
| Tuesday |
FDA Goes Global: Domestic Mission – Global Presence |
| Tuesday |
Standards in Your Future: How SAFE-BioPharma, IHE and CDISC Are Collaborating to Improve Safety Reporting |
| Tuesday |
Evaluation of the Safety of Pharmaceuticals in the Environment (Water) |
| Tuesday |
Clinical Trial Oversight: Adverse Event Reporting and Handling of Incidental Findings |
| Tuesday |
Biomarkers for Drug Safety and Development: Perspectives from the Institute of Medicine and Industry |
| Tuesday |
Computerized Systems Used in Clinical Research: Best Practices from Peach - Part 1 |
| Tuesday |
Computerized Systems Used in Clinical Research: Best Practices from Peach - Part 2 |
| Tuesday |
The Impact of FDAAA and Health Information Technology on Drug Safety, Standards, and Data Stewardship: 2009 Update and Future Plans |
| Tuesday |
Drug Development and Statistics in Asia: Issues and Challenges |
| Tuesday |
Quality by Design (QbD) : Linking Quality to Safety |
| Wednesday |
New Approaches to Toxicity Testing to Support Pharmaceutical Development - Part 2 of 2: New Models |
| Wednesday |
New Approaches to Toxicity Testing to Support Pharmaceutical Development - Part 1 of 2: New Endpoints |
| Wednesday |
Addressing Suicidality in Clinical Trials |
| Wednesday |
Managing Drug Development Portfolios in a Safety-heightened Environment |
| Wednesday |
Regulatory Strategy in Global Drug Development |
| Wednesday |
Potentially Genotoxic Impurities, Metabolites and Degradates: The Need for an Integrated Approach to Safety Assessment |
| Wednesday |
Early-phase Clinical Trials: Confronting the Guinea-pigging Misconception |
| Wednesday |
Connect the Dots: The Map from Labeling Development to Marketing Claim |
| Wednesday |
Do Subvisible Particles Contribute to the Immunogenicity of Therapeutic Proteins? Gaps in Risk Evaluation and Mitigation |
| Wednesday |
The Multilingual Dimension: Best Practices for Addressing Global Content and Global XML |
| Wednesday |
An Introduction to FDA/CDER’s Safety First/Safe Use Postmarketing Safety Initiative |
| Wednesday |
Opportunities for the Treatment of Rare Diseases |
| Wednesday |
Clinical Automation Systems in Phase 1 Clinical Research |
| Wednesday |
Virtual Project Teams: Best Practices for Improving Product Development Efficiency |
| Wednesday |
Optimizing Clinical Trial Material Supply Planning |
| Wednesday |
CDISC Pilots |
| Wednesday |
Pharmacovigilance and Product Liability |
| Wednesday |
Patient-reported Outcomes Consortium: A Public-private Partnership |
| Wednesday |
Harmonization Scope for Natural Health Products Regulatory Requirements |
| Wednesday |
Safety before and after Approval of Natural Health Products |
| Wednesday |
Developing Safe and Effective Biological Medicines: Phase 2 and Beyond |
| Wednesday |
Relative Efficacy/Effectiveness: A New Interface between Drug Regulation and Health Technology Assessment? |
| Thursday |
Preclinical Safety Evaluation of Novel Adjuvants and Vaccines |
| Thursday |
Breaking Boundaries: Making Sense of Your Data through Collaborative Visualization |
| Thursday |
Women in HIV Trials: A Comprehensive Review and Meta-analysis |
| Thursday |
Pharmacovigilance from the Medical Writer Perspective |
| Thursday |
Data Management Challenges within Academic Research Centers |
| Thursday |
Human Subject Protection Programs: Complex Issues for the IRB |
| Thursday |
Implementing Health Informatics Solutions in the Life Sciences Industry |
| Thursday |
Informed Consent: Promise, Pledge, Contract or Platitude? |
| Thursday |
New Paradigms in Drug Regulation? |
| Thursday |
Updating ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals |
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