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21 CFP Part 11 (Electronic Records & Signatures)
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Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
PRA05
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$
225.00
Regulatory Affairs: Electronic Common Technical Document (eCTD)
PRA04
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$
225.00
Regulatory Affairs: Essentials for Human Medicinal Products – EU and US
PRA01
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$
225.00
Clinical Trial Safety Reporting Requirements in the EU and USA
CT14
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$
225.00
Safety Reporting in Clinical Trials (Adverse Event Reporting)
CT13
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$
225.00
Introduction to Drug Safety and Pharmacovigilance
AV02
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$
225.00
Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation
CT11
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$
225.00
Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
GCP007
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$
225.00
Clinical Trials: Preparing for an Audit or Inspection
GCP006
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$
225.00
Clinical Trials: Preparation and Design
GCP002
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$
199.00
Clinical Trial eSystems Inspection Readiness
CP021a
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199.00
The General Data Protection Regulation (GDPR) and Clinical Trials
CP009a
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