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Wednesday, August 23, 2017
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Pharmaceutical Regulatory AffairsPharmaceutical Regulatory Affairs Training and Professional Certification Courses

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied

Certification Training US Pharmaceutical Regulatory Affairs Professional Certification Program Professional Certification Course
US Pharmaceutical Regulatory Affairs Professional Certification Program
Course ID: PRA00B1
PRICE: $995.00 | Read more >>

Certification Training International Pharmaceutical Regulatory Affairs Professional Certification Program Professional Certification Course
International Pharmaceutical Regulatory Affairs Professional Certification Program
Course ID: PRA00A1
PRICE: $1295.00 | Read more >>

Certification Training Regulatory Affairs: Essentials for Human Medicinal Products - EU and US Regulatory Affairs: Essentials for Human Medicinal Products – EU and US
Course ID: PRA01
PRICE: $195 | Read more >>

Certification Training Regulatory Affairs: Orphan Drug Application - EU and US Regulatory Affairs: Orphan Drug Application – EU and US
Course ID: PRA02
PRICE: $145 | Read more >>

Certification Training Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
Course ID: PRA03
PRICE: $145 | Read more >>

Certification Training Regulatory Affairs: Electronic Common Technical Document (eCTD) Regulatory Affairs: Electronic Common Technical Document (eCTD)
Course ID: PRA04
PRICE: $195 | Read more >>

Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Course ID: PRA05
PRICE: $195 | Read more >>

Certification Training Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US
Course ID: PRA06
PRICE: $195 | Read more >>

Certification Training Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
Course ID: PRA07
PRICE: $195 | Read more >>

Certification Training Regulatory Affairs: The European Centralized Procedure (CP) Regulatory Affairs: The European Centralized Procedure (CP)
Course ID: PRA20
PRICE: $145 | Read more >>

Certification Training Regulatory Affairs: The Mutual Recognition Procedure (MRP) Regulatory Affairs: The Mutual Recognition Procedure (MRP)
Course ID: PRA21
PRICE: $145 | Read more >>

Certification Training Regulatory Affairs: Variations to Marketing Authorizations in Europe Regulatory Affairs: Variations to Marketing Authorizations in Europe
Course ID: PRA22
PRICE: $195 | Read more >>

Certification Training Regulatory Affairs: The Decentralised Procedure (DCP) Regulatory Affairs: The Decentralised Procedure (DCP)
Course ID: PRA23
PRICE: $145 | Read more >>

Certification Training Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
Course ID: PRA08
PRICE: $125 | Read more >>


Medical Device Regulatory Affairs Programs

Certification Training Global Medical Device Regulatory Affairs Professional Certification Program Professional Certification Program
Global Medical Device Regulatory Affairs Professional Certification Program
Course ID: MD00S1
PRICE: $395 | Learn More…

Certification Training US Medical Device Regulatory Affairs Professional Certification Program Professional Certification Program
US Medical Device Regulatory Affairs Professional Certification Program
Course ID: MD00S2
PRICE: $395 | Learn More…

Certification Training Medical Device Quality Management Professional Certification Program Professional Certification Program
Medical Device Quality Management Professional Certification Program
Course ID: MD00S3
PRICE: $539 | Learn More…

Certification Training Medical Device Regulatory Affairs: Australian Overview Medical Device Regulatory Affairs: Australian Overview
Course ID: MDA1
PRICE: $169 | Learn More…

Certification Training Medical Device Regulatory Affairs: Australian Requirements for Registration Medical Device Regulatory Affairs: Australian Requirements for Registration
Course ID: MDA2
PRICE: $169 | Learn More…

Certification Training Medical Device Regulatory Affairs: Global Medical Device Regulatory Affairs: Global
Course ID: MDG1
PRICE: $149 | Learn More…

Certification Training Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements
Course ID: MDG2
PRICE: $149 | Learn More…

Certification Training Medical Device Regulatory Affairs: Global Risk Management Medical Device Regulatory Affairs: Global Risk Management
Course ID: MDG3
PRICE: $149 | Learn More…

Certification Training Medical Device Quality Management: Managing a QMS Medical Device Quality Management: Managing a QMS
Course ID: MDQ1
PRICE: $199 | Learn More…

Certification Training Medical Device Quality Management: Documentation and Records Medical Device Quality Management: Documentation and Records
Course ID: MDQ2
PRICE: $199 | Learn More…

Certification Training Medical Device Quality Management: CAPA Systems Medical Device Quality Management: CAPA Systems
Course ID: MDQ3
PRICE: $199 | Learn More…

Certification Training Medical Device Regulatory Affairs: US Overview Medical Device Regulatory Affairs: US Overview
Course ID: MDU1
PRICE: $169 | Learn More…

Certification Training Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820 Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820
Course ID: MDU2
PRICE: $169 | Learn More…

Certification Training Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme
Course ID: MDU3
PRICE: $169 | Learn More…

Certification Training Australian Medical Device Regulatory Affairs Professional Certification Program Professional Certification Program
Australian Medical Device Regulatory Affairs Professional Certification Program
Course ID: MD00S4
PRICE: $329 | Learn More…


For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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