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Pharmaceutical Regulatory Affairs
Pharmaceutical Regulatory Affairs
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Clinical Research
Good Clinical Practice (GCP)
HIPAA & GDPR
Medical Device
Regulatory Affairs
Data Integrity
Drug Safety & Pharmacovigilance
Good Laboratory Practice (GLP)
Good Clinical Laboratory Practice (GCLP)
Good Manufacturing Practice (GMP)
GMP for Food Manufacturing
GMP for Pharmaceutical Manufacturing
HR - Equal Employment Opportunity (EEO)
Occupational Safety and Health Administration (OSHA)
Pharmaceutical Sales and Marketing Compliance
Pharmacokinetics and Pharmacodynamics
Regulatory Affairs
Approvals for Clinical Research
Marketing Pharmaceuticals
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Validation
Computer Software Validation (CSA)
Computer System Validation
21 CFP Part 11 (Electronic Records & Signatures)
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$
1,795.00
Global Pharmaceutical Regulatory Affairs Professional Certification Program
PRA00A1
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$
1,295.00
US Pharmaceutical Regulatory Affairs Professional Certification Program
PRA00B1
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$
225.00
Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USA
SUB15
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$
225.00
Regulatory Affairs: Variations to Marketing Authorizations in Europe
PRA22
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$
225.00
Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USA
PRA07
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$
225.00
Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USA
PRA06
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$
225.00
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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$
195.00
Regulatory Affairs: The Decentralized Procedure (DCP)
PRA23
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$
195.00
Regulatory Affairs: The Mutual Recognition Procedure (MRP)
PRA21
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$
145.00
Regulatory Affairs: The 505(b)(2) Application for Marketing Approval in the USA
SUB16
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