|Credits: 0.75 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Drug Safety.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $189.00
Training Program: Drug Safety: Urgent Safety Restrictions
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
In response to a safety signal, a regulatory action, called the Urgent Safety Restriction (USR), is taken. This action is intended to push an interim change to the marketing authorization’s terms for a medicinal product in Europe. Described within this class are the procedures and principles for Urgent Safety Restrictions (USRs).
Objectives contained within this course are as follows: To train on what to do following a Urgent Safety Restriction, a specification for the requirements for a variation application is necessary; review an outline of the 24-hour procedure for a USR’s execution; offer a description of general regulatory requirements for initiation and preparation of a USR; provide a description of the triggering of a USR; and to offer an explanation of the purpose of Europe’s Urgent Safety Restrictions.
This is an online training course with immediate access upon enrollment. Username, password, and instructions will be emailed to the student immediately following an online enrollment. Program includes high-quality animations, progress checks, easy navigation, and voice-overs. Some select training programs make available references and/or course notes in PDF format. 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 BioPharma Institute
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.
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:
The Drug Safety: Urgent Safety Restrictions course is found in the following professional certification program(s):
Overview – An outline of the course’s objectives, and notes on terminology.
Principles – In this session we define Urgent Safety Restriction and explain its purpose in the European Union and other countries of the European Economic Area. We describe how an USR may be triggered. Finally, we give some examples of safety signals that may, and some that may not, give rise to an USR.
Procedure – In this session we describe how to prepare for and initiate an Urgent Safety Restriction (USR) for a centrally authorized product and for a product authorized through the Mutual Recognition or Decentralized Procedure. We outline the 24-hour procedure for execution of an USR, and the follow-up actions required, in each case. Finally, we specify the requirements for a variation application following an USR.
Assessment – Multiple-choice mastery assessment.
Who will benefit from this module?
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.