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Saturday, January 19, 2019
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Pharmaceutical Regulatory Affairs: Orphan Drug Application – EU and US (PRA002)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: Pharmaceutical Regulatory Affairs: Orphan Drug Application – EU and US
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. 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 information necessary to enable the preparation of applications for orphan drug status in the EU and USA. The procedures for making an application are detailed, including the collection of supporting data and the acquisition of protocol assistance. In Europe the Centralized Procedure is now the mandatory route to gain marketing authorization for orphan products. This online course will serve as a useful reference tool to keep abreast of the impact of the new regulatory requirements.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, 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 training: 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
  • 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
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The Pharmaceutical Regulatory Affairs: Orphan Drug Application – EU and US course is found in the following professional certification program(s):


Professional Designation in US Pharmaceutical Regulatory Affairs: … Learn more


COURSE OUTLINE:


Introduction: This session looks at issues which have to be considered when developing Orphan Products in the EU and USA, including the costs of development, development risks, advantages of orphan status, how to obtain advice and strategy for orphan applications.

Orphan medicinal products in the EU: This session looks at the role of the EMEA and COMP, the definition of an orphan product, how to apply for orphan designation, supporting data required, and the approval process including refusal and the appeal procedure.

Orphan medicinal products in the USA: This session looks at the role of the FDA’s OOPD, the definition of an orphan product, how to apply for orphan designation, supporting data required, and the approval process including refusal and the appeal procedure.

COURSE OBJECTIVES:


Students completing this course should be able to: Describe the advantages of orphan drug status in the EU and USA. Explain how to prepare applications for orphan drug designation in the EU and USA. Understand the approval process for orphan designation in the EU and USA and how to proceed if orphan designation is refused.


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