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

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

Certification Training
 
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Method of Training: Online / Self-paced eLearning.
Credits: 1.5 CPD Credits.
Duration: ~1.5 hour(s).
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

Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining 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.

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 passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


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.

The Regulatory Affairs: Orphan Drug Application - EU and US Course is Included in the Following Professional Certification Programs:


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

Full List of Programs in the Pharmaceutical Regulatory Affairs Catalog:



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

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

Regulatory Affairs: Essentials for Human Medicinal Products - EU and US: This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to mai ... Learn more

Regulatory Affairs: Orphan Drug Application - EU and US: 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 thr ... Learn more

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format: The CTD is the internationally recognized standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European Economic Area, required for prescription ... Learn more

Regulatory Affairs: Electronic Common Technical Document (eCTD): The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the ... Learn more

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US: This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. Th ... Learn more

Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US: An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful approval, what format and content ... Learn more

Regulatory Affairs: The European Centralized Procedure (CP): This online course describes the procedure's various players, the duration and sequence of the stages involved, and requirements on timing, format, and content of submissions. In the Centralized Procedure, one ... Learn more

Regulatory Affairs: The Mutual Recognition Procedure (MRP): The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorization within the European Economic Area (EEA) on the basis of a single application. A nati ... Learn more

Regulatory Affairs: Variations to Marketing Authorizations in Europe: Changes to the terms of marketing authorizations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the co ... Learn more

Regulatory Affairs: The Decentralised Procedure (DCP): The DCP is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA) on the basis of a single application. It can be used only for a produ ... Learn more

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies: This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biologica ... Learn more

Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA: The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than ... Learn more

Regulatory Affairs: Essentials of Monoclonal Antibodies: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, ... Learn more

Regulatory Affairs for Monoclonal Antibodies Professional Certification Program: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment
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  • 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 electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • 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
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
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  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization

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