File List
# | File Name | File Type | Action |
1 | Emerging Issues in Human Subjects Protection | PPT | View / Download |
2 | Intellectual Property Provisions in CTAs | PPT | View / Download |
3 | Process Improvement in Clinical Trials | PPT | View / Download |
4 | Quality by Design | PPT | View / Download |
5 | Behind the Scenes -How Site Selection Really Works | PPT | View / Download |
6 | Human Subjects Protection Leadership Forum (Part 2) | PPT | View / Download |
7 | Master Class - Good Clinical Practice (Part 1) | PPT | View / Download |
8 | An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA | PPT | View / Download |
9 | Investigation of the Safety Profiles of Japanese Clinical Trials | PPT | View / Download |
10 | Cost-Effectiveness Analysis of EGFR Mutation Testing and Gefitinib as First-Line Therapy for Non–Small Cell Lung Cancer | View / Download | |
11 | Managing Risk with Contracts - Informed Consent, Subject Injury, Insurance & Indemnification | PPT | View / Download |
12 | Recent Developments in Clinical Trial Agreements | View / Download | |
13 | Confidential Disclosure Agreements | PPT | View / Download |
14 | CTA Sticking Points | PPT | View / Download |
15 | FDA Inspections -Handling the Consequences | PPT | View / Download |
16 | Recent Developments in Subject Data Privacy & Security | PPT | View / Download |
17 | Regulatory Inspections of Research Sites | PPT | View / Download |
18 | Regulatory Myths | PPT | View / Download |
19 | Sensible Payment Terms in CTAs | PPT | View / Download |
20 | Sponsor - CRO Contracts | PPT | View / Download |
21 | The Scales of Beneficence - Weighing Risk vs. Benefit in Clinical Research | PPT | View / Download |
22 | Best Practices in Outsourcing to CROs | PPT | View / Download |
23 | From Compliance to Competency - Core Competencies for the Clinical Research Professional | PPT | View / Download |
24 | Just International - A Moderated Discussion | PPT | View / Download |
25 | Just Sites - A Moderated Discussion | PPT | View / Download |
26 | Just Sponsors - A Moderated Discussion | PPT | View / Download |
27 | Five Things We Just Can't Seem to Get Right - A Panel Discussion | PPT | View / Download |
28 | Paperless Clinical Trials | PPT | View / Download |
29 | Metrics for Site Management & Business Development | PPT | View / Download |
30 | Quality Agreements | PPT | View / Download |
31 | Quality Systems for Research Sites | PPT | View / Download |
32 | Risk-Based & Centralized Site Monitoring - Implementation | PPT | View / Download |
33 | Risk-Based & Centralized Site Monitoring - Implementation | PPT | View / Download |
34 | Site Monitoring with an Auditor's Eye | PPT | View / Download |
35 | Site Operations Challenges - Do You Really Expect Us to Do This? A Panel Discussion | PPT | View / Download |
36 | Chairman's Opening Remarks | PPT | View / Download |
37 | Dissecting a Clinical Trial Agreement (Part 2) | PPT | View / Download |
38 | Dissecting a Clinical Trial Agreement (Part 1) | PPT | View / Download |
39 | Master Class - Good Clinical Practice (Part 2) | PPT | View / Download |
40 | IRB Best Practices | PPT | View / Download |
41 | A Practical Guide to Data Monitoring Committees in Adaptive Trials | PPT | View / Download |
42 | ICH: Strengths, Weaknesses, and Future Tasks | PPT | View / Download |
43 | Adaptive Design | View / Download | |
44 | A Bayesian Stopping Rule for Sequential Monitoring of Serious Adverse Events | View / Download | |
45 | Biopharmaceutical Contact Centers and Combination Products: Results of a Benchmark Survey | View / Download | |
46 | The Changing Landscape of Drug Companies | View / Download | |
47 | The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle | View / Download | |
48 | Interconnectivity of Disparate Nonclinical Data Silos for Drug Discovery and Development | View / Download | |
49 | Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug System | View / Download | |
50 | Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule | View / Download | |
51 | Key Considerations in the Transition to Risk-Based Monitoring | View / Download | |
52 | Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person | View / Download | |
53 | Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations | View / Download | |
54 | Consideration of Factors Affecting the Safety Index in Early Clinical Drug Development | View / Download | |
55 | Teratogenic Drugs and Risk Management: An Implementation Assessment | View / Download | |
56 | Ten Reasons Why This Study Won't Work | PPT | View / Download |
57 | The Sunshine Act | PPT | View / Download |
58 | Where to From Here? Game Changers that Can Revolutionize Clinical Research | PPT | View / Download |
59 | Regulatory agencies - USFDA, EMEA, DCG (I) and scientific communication | View / Download | |
60 | Regulatory agencies - USFDA, EMEA, DCG (I) and scientific communication | View / Download |