Clinical Trials
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$179
Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk MitigationSandra “SAM” SatherOn-Demand -
$279
Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!Sandra “SAM” SatherOn-Demand -
$279
Clinical Quality Management Systems (QMS): Establishing a Practical & Compliant ProgramPenelope Przekop, MSQA, RQAP-GCPOn-Demand -
$279
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & PatientsBetsy FallenOn-Demand -
$279
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAsPenelope Przekop, MSQA, RQAP-GCPOn-Demand -
$279
Right to Try Legislation: Impact on Industry, Health Authorities, and PatientsMichael PierroOn-Demand -
$279
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11Sandra “SAM” SatherOn-Demand -
$279
Electronic Document Management Systems (EDMS) & Electronic Common Technical Documents (eCTD): An OverviewDaniel Orfe, Betsy FallenOn-demand -
$279
The Impact of “Brexit” On Clinical Research – An Operational Readiness PrimerMichael PierroOn-Demand -
$279
Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and SuggestionsMichael PierroOn-Demand
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$1199
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$279
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$279
Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand -
$279
CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand
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$279
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$279
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand