Agenda

Día 1 23 jun 2013

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: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur

8:30 AM — 12:00 PM

#22: Global Reimbursement Systems: A Market Access Perspective

8:30 AM — 12:00 PM

#23: A Device Primer: 510(k)s, PMAs, IDEs

8:30 AM — 12:00 PM

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

9:00 AM — 5:00 PM

#50: Understanding and Navigating the Regulatory System in China

9:00 AM — 5:00 PM

#51: Quality Oversight of CROs-Clinical Vendors

9:00 AM — 5:00 PM

#52: Regulatory Affairs for Biologics

9:00 AM — 5:00 PM

#53: Clinical Statistics for Nonstatisticians

9:00 AM — 5:00 PM

#54: Art of Writing a Clinical Overview

9:00 AM — 5:00 PM

#55: Overview of Drug Development

9:00 AM — 5:00 PM

#56: Risk Communications

9:00 AM — 3:45 PM

#57: Preparing for a US FDA Advisory Committee Meeting

1:00 PM — 4:30 PM

#30: Analysis of Safety Data from Clinical Trials

1:00 PM — 4:30 PM

#31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned

1:00 PM — 4:30 PM

#32: Understanding Translational Medicine: Benefits and Innovative Approaches

1:00 PM — 4:30 PM

#34: Fourteen Steps from Research to Development

1:00 PM — 4:30 PM

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

1:00 PM — 6:00 PM

#40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges

1:00 PM — 6:00 PM

#41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions

Día 2 24 jun 2013

8:30 AM — 10:00 AM

11:00 AM — 12:30 PM

11:00 AM — 12:15 PM

11:00 AM — 12:30 PM

1:00 PM — 1:45 PM

2:30 PM — 4:00 PM

Día 3 25 jun 2013

8:00 AM — 9:30 AM

9:40 AM — 10:10 AM

10:15 AM — 11:45 AM

12:15 PM — 1:00 PM

1:45 PM — 3:15 PM

3:25 PM — 3:55 PM

4:00 PM — 5:30 PM

5:30 PM — 7:30 PM

Día 4 26 jun 2013

8:00 AM — 9:30 AM

10:15 AM — 11:45 AM

12:15 PM — 1:00 PM

1:45 PM — 3:15 PM

3:30 PM — 4:30 PM

4:00 PM — 5:30 PM

5:30 PM — 7:30 PM

Día 5 27 jun 2013

9:00 AM — 10:30 AM

10:45 AM — 12:15 PM

Día 6 28 jun 2013

8:00 AM — 5:00 PM

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DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Agenda

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