Student Login |


Tuesday, December 11, 2018
Home » Online Training Course

Drug Safety: Urgent Safety Restrictions (PV06)

Certification Training CPD Accredited TrainingCredits: 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

BioPharma Institute LogoTraining Program: Drug Safety: Urgent Safety Restrictions
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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.

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 Drug Safety: Urgent Safety Restrictions course is found in the following professional certification program(s):


Pharmacovigilance and Drug Safety Professional Certification Program: This professional certification program will provide the student with a comprehensive overview of the requirements and concepts necessary for a full understanding of overall drug safety and pharmacovigilance. I … Learn more


COURSE OUTLINE:


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.

COURSE OBJECTIVES:


Who will benefit from this module?

All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies with products authorized in Europe should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.

Objectives

  • Explain the purpose of Urgent Safety Restrictions in Europe

  • Describe how an USR may be triggered

  • Describe the general regulatory requirements for preparation and initiation of an USR

  • Outline the 24-hour procedure for execution of an USR

  • Specify the requirements for a variation application following an USR


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.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us
with as much detail as possible about your training project):