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Tutorials 

Register Title Date Time Credits Track(s)
#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development Sun, June 23 8:30AM - 12:00PM IACET Track 08 - Regulatory Affairs and Submissions
#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur Sun, June 23 8:30AM - 12:00PM IACET Track 08 - Regulatory Affairs and Submissions
#22: Global Reimbursement Systems: A Market Access Perspective Sun, June 23 8:30AM - 12:00PM IACET Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
#23: A Device Primer: 510(k)s, PMAs, IDEs Sun, June 23 8:30AM - 12:00PM CME, IACET Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
#25: Leadership: How to Organize and Lead People in Group Work Sun, June 23 8:30AM - 12:00PM IACET, PMI Track 16 - Professional Development
#30: Analysis of Safety Data from Clinical Trials Sun, June 23 1:00PM - 4:30PM ACPE, CME, IACET Track 14 - Clinical Safety and Pharmacovigilance
#31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned Sun, June 23 1:00PM - 4:30PM CME, IACET Track 14 - Clinical Safety and Pharmacovigilance
#32: Understanding Translational Medicine: Benefits and Innovative Approaches Sun, June 23 1:00PM - 4:30PM CME, IACET Track 08 - Regulatory Affairs and Submissions
#34: Fourteen Steps from Research to Development Sun, June 23 1:00PM - 4:30PM CME, IACET Track 08 - Regulatory Affairs and Submissions
#35: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions and Regulatory Document Writing Sun, June 23 1:00PM - 4:30PM IACET Track 08 - Regulatory Affairs and Submissions
#40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges Sun, June 23 1:00PM - 6:00PM CME, IACET Track 01 - Clinical Operations
#41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions Sun, June 23 1:00PM - 6:00PM IACET Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law
#50: Understanding and Navigating the Regulatory System in China Sun, June 23 9:00AM - 5:00PM IACET Track 08 - Regulatory Affairs and Submissions
#51: Quality Oversight of CROs-Clinical Vendors Sun, June 23 9:00AM - 5:00PM IACET Track 03 - Innovative Partnering Models and Outsourcing Strategies
#52: Regulatory Affairs for Biologics Sun, June 23 9:00AM - 5:00PM IACET Track 08 - Regulatory Affairs and Submissions
#53: Clinical Statistics for Nonstatisticians Sun, June 23 9:00AM - 5:00PM ACPE, CME, IACET Track 01 - Clinical Operations
#54: Art of Writing a Clinical Overview Sun, June 23 9:00AM - 5:00PM IACET Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
#55: Overview of Drug Development Sun, June 23 9:00AM - 5:00PM IACET, PMI Track 16 - Professional Development
#56: Risk Communications Sun, June 23 9:00AM - 5:00PM ACPE, CME, IACET, RN Track 14 - Clinical Safety and Pharmacovigilance
#57: Preparing for a US FDA Advisory Committee Meeting Sun, June 23 9:00AM - 3:45PM IACET Track 08 - Regulatory Affairs and Submissions


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