Pharmaceutical 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

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	Professional Certification Course Essentials in US Regulatory Affairs Professional Certification Program Course ID: PRA00B1 PRICE: $579 | Read more >>
	Professional Certification Course International Regulatory Affairs Professional Certification Program Course ID: PRA00A1 PRICE: $1995 | Read more >>
	Regulatory Affairs: Essentials for Human Medicinal Products – EU and US Course ID: PRA01 PRICE: $195 | Read more >>
	Regulatory Affairs: Orphan Drug Application – EU and US Course ID: PRA02 PRICE: $195 | Read more >>
	Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form Course ID: PRA03 PRICE: $195 | Read more >>
	Regulatory Affairs: Electronic Common Technical Document (eCTD) Course ID: PRA04 PRICE: $195 | Read more >>
	Regulatory Affairs: Registration of Monoclonal Antibodies Course ID: PRA005 PRICE: $195 | Read more >>
	Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA Course ID: PRA06 PRICE: $195 | Read more >>
	Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA Course ID: PRA07 PRICE: $195 | Read more >>
	Regulatory Affairs: The European Centralised Procedure (CP) Course ID: PRA20 PRICE: $195 | Read more >>
	Regulatory Affairs: The Mutual Recognition Procedure (MRP) Course ID: PRA21 PRICE: $195 | Read more >>
	Regulatory Affairs: EU Variations Procedure Course ID: PRA22 PRICE: $195 | Read more >>
	Regulatory Affairs: The Decentralised Procedure (DCP) Course ID: PRA23 PRICE: $195 | Read more >>

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Medical Device Regulatory Affairs Programs

	Professional Certification Program Global Medical Device Regulatory Affairs Professional Certification Program Course ID: MD00S1 PRICE: $395 | Learn More…
	Professional Certification Program US Medical Device Regulatory Affairs Professional Certification Program Course ID: MD00S2 PRICE: $395 | Learn More…
	Professional Certification Program Medical Device Quality Management Professional Certification Program Course ID: MD00S3 PRICE: $539 | Learn More…
	Medical Device Regulatory Affairs: Australian Overview Course ID: MDA1 PRICE: $169 | Learn More…
	Medical Device Regulatory Affairs: Australian Requirements for Registration Course ID: MDA2 PRICE: $169 | Learn More…
	Medical Device Regulatory Affairs: Global Course ID: MDG1 PRICE: $149 | Learn More…
	Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements Course ID: MDG2 PRICE: $149 | Learn More…
	Medical Device Regulatory Affairs: Global Risk Management Course ID: MDG3 PRICE: $149 | Learn More…
	Medical Device Quality Management: Managing a QMS Course ID: MDQ1 PRICE: $199 | Learn More…
	Medical Device Quality Management: Documentation and Records Course ID: MDQ2 PRICE: $199 | Learn More…
	Medical Device Quality Management: CAPA Systems Course ID: MDQ3 PRICE: $199 | Learn More…
	Medical Device Regulatory Affairs: US Overview Course ID: MDU1 PRICE: $169 | Learn More…
	Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820 Course ID: MDU2 PRICE: $169 | Learn More…
	Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme Course ID: MDU3 PRICE: $169 | Learn More…
	Professional Certification Program Australian Medical Device Regulatory Affairs Professional Certification Program Course ID: MD00S4 PRICE: $329 | Learn More…

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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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COMMENTS or Suggest a course: (For pricing information, please provide us with as much detail as possible about your training project):	Pharmaceutical Regulatory Affairs