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Wednesday, March 20, 2019
Home » Professional Designation in US Pharmaceutical Regulatory Affairs

Professional Designation in US Pharmaceutical Regulatory Affairs (PRA000S1)

Certification Training
Duration: 13 hours, Online (the average time to complete the training program, including final assessments).
Credit Hours: See individual courses for credit hours assigned.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the BioPharma Institute for more information.
Training Provided By: BioPharma Institute

BioPharma Institute LogoThe Professional Designation in US Pharmaceutical Regulatory Affairs includes these individual courses:

Pharmaceutical Regulatory Affairs: Essentials for Human Medicinal Products - EU and US: This foundation-level course is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain a ... Learn more

Pharmaceutical Regulatory Affairs: Orphan Drug Application - EU and US: Orphan drugs are those for relatively rare indications. Special procedures and incentives apply to their registration, to encourage pharmaceutical companies to develop them. This online course provides informat ... Learn more

Pharmaceutical Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form: The CTD is the mandatory format for regulatory submissions in the European Union, Japan, Canada and Australia and strongly recommended in the USA. It is accepted widely elsewhere. This online course explains th ... Learn more

Pharmaceutical Regulatory Affairs: Electronic Common Technical Document (eCTD): The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of registration dossiers. It broadens the scope of the CTD to include information on var ... Learn more

Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA: This course describes FDA expectations of applications for the licensing of generic products. It provides the background knowledge to effectively plan, gather and assemble the necessary documentation for the su ... Learn more

Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA: A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA. For successful FDA approval, what content and form ... Learn more

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

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

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