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Regulatory Affairs: Orphan Drug Application – EU and US (PRA02)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 1.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00 LogoTraining Program: Regulatory Affairs: Orphan Drug Application – EU and US
Training Provided By:

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

Orphan drugs are those for relatively rare indications. Special incentives and procedures apply to their registration to encourage the development of them by the pharmaceutical companies. This course provides information needed to enable the preparation of applications for orphan drug status in the USA and EU.

The procedures for making an application are detailed, that includes the acquisition of protocol assistance and collection of supporting data. In Europe, the Centralized Procedure is now the mandatory method to gain authorization for marketing of orphan products. This class serves as a fully utilitarian reference tool to help stay informed as to the impact of the new regulatory requirements.

A passing grade of 80% or more is required. Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.

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, 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

The Regulatory Affairs: Orphan Drug Application – EU and US Course is Found in the Following Professional Certification Program(s):

International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more


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.


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.


313 Regulatory jobs found.
Displaying jobs #1-4.

Clinical Research Regulatory Affairs Manager
Posted Date: 2017-06-19
Medix – United States, WA, Seattle, 98127

Regulatory Compliance Analyst
Posted Date: 2017-06-19
Apex Life Sciences – United States, MD, Rockville, 20849

Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404

Study Start Up Regulatory Submissions Coordinator
Posted Date: 2017-06-23
Medpace – United States, OH, Cincinnati, 45208

See more Regulatory Jobs

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