Agenda

Día 1 15 jun 2014

8:30 AM — 12:00 PM

#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

8:30 AM — 12:00 PM

#21: The Sunshine Act: Understanding the Essentials of Compliance

8:30 AM — 12:00 PM

#22: Preparing for a US FDA Advisory Committee Meeting

8:30 AM — 12:00 PM

#23: Leadership: How to Organize and Lead People in Group Work

8:30 AM — 12:00 PM

#24: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing

9:00 AM — 5:00 PM

#40: Analysis of Safety Data from Clinical Trials

9:00 AM — 5:00 PM

#41: Quality Oversight of CROs-Clinical Vendors

9:00 AM — 5:00 PM

#42: Regulatory Affairs for Biologics

9:00 AM — 5:00 PM

#43: Clinical Statistics for Nonstatisticians

9:00 AM — 5:00 PM

#44: Quality by Design: From Theory to Practice

9:00 AM — 5:00 PM

#45: Risk Management Plan

9:00 AM — 5:00 PM

#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions

1:00 PM — 4:30 PM

#30: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation

1:00 PM — 4:30 PM

#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria

1:00 PM — 4:30 PM

#32: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine

1:00 PM — 4:30 PM

#33: Bayesian Evidence Synthesis and Network Meta-analysis

1:00 PM — 4:30 PM

#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

1:00 PM — 4:30 PM

#35: Understanding Translational Medicine: Benefits and Innovative Approaches

Día 2 16 jun 2014

8:30 AM — 10:00 AM

11:00 AM — 12:30 PM

1:00 PM — 2:00 PM

2:30 PM — 4:00 PM

Día 3 17 jun 2014

8:00 AM — 9:30 AM

8:00 AM — 9:00 AM

8:00 AM — 9:30 AM

8:00 AM — 9:00 AM

9:45 AM — 10:15 AM

10:30 AM — 12:00 PM

10:30 AM — 11:30 AM

10:30 AM — 12:00 PM

10:30 AM — 11:30 AM

10:30 AM — 12:00 PM

11:45 AM — 12:30 PM

12:45 PM — 1:15 PM

1:30 PM — 3:00 PM

1:30 PM — 2:30 PM

1:30 PM — 3:00 PM

1:30 PM — 2:30 PM

1:30 PM — 3:00 PM

2:45 PM — 3:15 PM

3:30 PM — 5:00 PM

3:30 PM — 4:30 PM

3:30 PM — 5:00 PM

3:30 PM — 4:30 PM

3:30 PM — 5:00 PM

3:30 PM — 4:30 PM

Día 4 18 jun 2014

8:00 AM — 9:30 AM

8:00 AM — 9:00 AM

8:00 AM — 9:30 AM

8:00 AM — 9:00 AM

8:00 AM — 9:30 AM

8:00 AM — 9:00 AM

8:00 AM — 9:30 AM

9:45 AM — 10:15 AM

10:30 AM — 12:00 PM

10:30 AM — 11:30 AM

10:30 AM — 12:00 PM

10:30 AM — 11:30 AM

11:45 AM — 12:15 PM

12:30 PM — 1:15 PM

1:30 PM — 3:00 PM

1:30 PM — 2:30 PM

1:30 PM — 3:00 PM

1:30 PM — 2:30 PM

3:30 PM — 5:00 PM

Día 5 19 jun 2014

9:00 AM — 10:30 AM

9:00 AM — 10:00 AM

9:00 AM — 10:30 AM

10:45 AM — 12:15 PM

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DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

Agenda

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