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First Name

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Regulatory Compliance Aspect(s) – Choose all that Apply

Audit

Bioanalysis

Biomarkers

Case Study Report (CSR)

Chemistry Manufacturing Controls (CMC)

Clinical Laboratory Improvement Amendments (CLIA)

Companion Diagnostic (CDx)

Corrective Action-Preventive Action (CAPA)

electronic Case Report Form (eCRF)

European Medicines Agency (EMA)

Food and Drug Administration (FDA)

Good Documentation Practice (GDP)

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Good Pharmacovigilance Practice (GVP)

Informed Consent Form (ICF)

Inspection

Inspectional Observations - Form 483

Investigational Device Exempt (IDE)

Investigational New Drug (IND)

Investigator's Brochure (IB)

Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

Multinational Medical Device Single Audit Program (MDSAP)

New Drug Application (NDA)

Premarket Approval (PMA)

Quality Management System (QMS)

Significant Risk Determination (SRD)

Standard Operating Procedure (SOP)

Training

Trial Master File (TMF)

Vialing and Labeling

Warning Letter