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Title Event Type Day Time Track(s) Credits
Accelerating Research in a Large Health Care System: Streamlining Research Review and Study Initiation Workshop Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
CDER Town Hall (Part 1 of 2) Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 18 - Global Regulatory ACPE, CME, IACET, RN
Exploring Responder-Patient Clinical Study Design Approaches Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning ACPE, CME, IACET, RN
FDA Drug Claims Substantiation after IMS and Caronia: Will Court Scrutiny Based on the First Amendment Lead to Change in Current Policy and Practice? Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
GCP Quality Agreements Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Hot Topics in Medical Devices Labeling: US and Global Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Independent Consultant or Permanent Role: Get the Position You Want (Tips from Insiders) Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Keeping It Together: Syncing CRO Data and Metrics Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Qualifying a Software Vendor in a Regulated Industry Session Thursday, Jun 19 9:00AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, PMI, RN
Safety in Special Situations: Stem Cells, Vaccines, and Combination Products Symposium Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Today's Dynamic Medical Science Liaison Environment Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Universal Health Coverage and Health Technology Assessment in Emerging Asia Pacific Countries Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
A Hitchhiker's Guide to Working with Management Consultants Workshop Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Bringing Quality to Quality Metrics Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
CDER Town Hall (Part 2 of 2) Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 18 - Global Regulatory ACPE, CME, IACET, RN
Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Ethnic Difference in Clinical Trial Data: A 15-Year History of an Investigation by Regulatory Agencies and Industry Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
How Can Studies that Inform Relative Effectiveness Best Be Incorporated into Global Drug Development Plans? Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
Innovative Patient Recruitment Solutions for Rare Disease Clinical Trials Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Parents as Partners: Overcoming Unique Challenges to Pediatric Recruitment and Retention Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 17 - Rare/Orphan Diseases CME, IACET, RN
Risk-Based Monitoring: Where We Are and Where We Are Headed Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
The Evolution of Strategic Partnerships and the Four P's of International Relationship Building Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Trends in Biosimilars Regulation Within Developed and Emerging Markets Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Walking the Tightrope of Talent Acquisition and Retention: The Balancing Act for Maintaining Productivity, Efficiency, and Quality Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, PMI, RN