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Home » Regulatory Affairs: Orphan Drug Application - EU and US

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

Certification Training
 
Rated 4.00/5
6 reviews
Method of Training: Online / Self-paced eLearning.
Credits: 1.5 CPD Credits.
Duration: ~90 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Training Program: Regulatory Affairs: Orphan Drug Application - EU and US
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.

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Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning.

For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our training programs cater to both small-scale (2-100 students) and large-scale (100+ students) training requests. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and our training solutions are customizable to any organization's training needs.



Regulatory Affairs: Orphan Drug Application - EU and US course is included in the following Professional Certification Programs:



 Professional Certification Program: 
International Pharmaceutical Regulatory Affairs Professional Certification Program
Course ID: PRA00A1
Price: $1795.00 (USD) | Learn more

 Professional Certification Program: 
US Pharmaceutical Regulatory Affairs Professional Certification Program
Course ID: PRA00B1
Price: $1295.00 (USD) | 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.

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
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