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Sunday, December 16, 2018
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Regulatory Affairs: Orphan Drug Application – EU and US (PRA02)

Certification Training CPD Accredited TrainingCredits: 1.5 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

BioPharma Institute LogoTraining Program: 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.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because they are commercially unattractive. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This course describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

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 75% 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.

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By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute 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) 424-6576 or send us an email at support@biopharmainstitute.com 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, 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 Regulatory Affairs: Orphan Drug Application – EU and US course is found in the following professional certification program(s):


International Pharmaceutical 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

US Pharmaceutical Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Comm … Learn more


COURSE OUTLINE:


Module overview – An outline of the module’s scope and objectives, and notes on terminology.

Rare diseases and orphan drugs – Development of medicines for prevention, diagnosis, or treatment of rare diseases is commercially unattractive, so governments offer incentives to encourage it. In this session, we introduce the concept of orphan drug designation, discuss how it fits within a product development strategy, and identify some important sources of information on rare diseases and orphan drugs.

US designation – Legislation to encourage research and development of drugs for rare diseases was introduced first in the USA. In this session we describe the US legal framework for orphan drug designation and specify the incentives offered. We set out the criteria for orphan designation and how they should be satisfied. We list the contents of an application for designation and outline how to apply. Finally we identify the sponsor’s obligations and options after designation.

European designation – In this session we describe the European Union’s legal framework for orphan medicine designation and specify the incentives offered. We set out the criteria for orphan designation and how they should be satisfied. We specify the contents of an application for designation, describe how to apply, discuss the procedures for validation and evaluation of the application, and outline the provisions for appeal against refusal of designation. Finally we identify the sponsor’s obligations and options after designation.

Assessment – Multiple-choice mastery assessment.

COURSE OBJECTIVES:


Who will benefit from this module?
This module is intended primarily for regulatory affairs professionals. Staff inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course; more-experienced personnel will find it a useful reference tool. More generally, it will be of interest to all those involved in the development and registration of medicinal products.

Objectives

  • Explain why and how governments encourage the development of medicines for rare human diseases, and identify important sources of information.

  • Specify incentives offered for the development of medicines for rare diseases in the USA and in Europe.

  • State the criteria for orphan drug designation in the USA and in Europe.

  • List the contents of an application for orphan designation in the USA and in Europe, describe how to make an application in each case, and outline the process of review by the regulatory authority.

  • Outline the sponsor’s obligations and options after orphan designation in the USA and in Europe.


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