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Products

10-Hour Advanced Clinical Project Management Skills Development

10-Hour Advanced Clinical Project Management Skills Development

$1,795.00
10-Hour Clinical Research Manager Skills Development Series

10-Hour Clinical Research Manager Skills Development Series

$1,795.00
10-Hour Clinical Trial Start-Up Series

10-Hour Clinical Trial Start-Up Series

$1,795.00
10-Week Advanced FDA Post-Marketing Pharmacovigilance Auditing

10-Week Advanced FDA Post-Marketing Pharmacovigilance Auditing

$2,195.00

Products

Drug Development and FDA Regulations

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

Electronic Informed Consent Guidance: Regulatory Updates

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components

Essential Documentation in Clinical Trials at Research Sites

Establishing Quality Tolerance Limits (E6(R2) and E6(R3))

eTMF Implementation Strategies

EU Clinical Trial Regulation (EU-CTR) Requirements

EU Guideline on Computerised Systems and Electronic Data in Clinical Trials

Expediting Drug & Biologics Development: A Strategic Approach 2021

FDA Drug Approval Process

FDA's Draft Guidance on Ethical Considerations for Clinical Investigations of Medical Products Involving Children

FDA's Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice

FDA's February 2025 Guidance Update: Key Changes for IRBs and Clinical Investigators

FDAEEs Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

Fundamentals of Good Clinical Practice (ICH E6 R3)

GCP Renovation (ICH E8(R1) and ICH E6(R3))

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Good Clinical Practice for Investigators and Coordinators (ICH E6 R3)

Good Clinical Practice for Sponsors & Service Providers (ICH E6 R3)

Good Clinical Practice: A Question & Answer Reference Guide 2020/2021

Good Clinical Practice: A Question & Answer Reference Guide 2020/2021 (Electronic)

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025 (Electronic)