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Drug Safety: Urgent Safety Restrictions (PV06)

Certification Training
 
Rated 4.50/5
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Credits: 0.75 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: 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. BioPharma Institute Reviews

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.

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


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

Good Pharmacoepidemiology Practice Professional Certification Program: This professional certification program will provide the student with a comprehensive overview of the requirements and concepts necessary for a strong understanding of Good Pharmacoepidemiology Practice, drug s ... 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

All Courses in the Drug Safety Catalog:


Drug Safety: Signal Detection and Management in Pharmacovigilance: The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into a ... Learn more

Drug Safety: Risk Management Planning for Medicinal Products: Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans ... Learn more

Drug Safety: Urgent Safety Restrictions: 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 medicina ... Learn more

Introduction to Drug Safety and Pharmacovigilance: Drug safety monitoring and risk management are vitally important for medicinal product developers, license holders and clinical investigators. In addition to their duty to protect public health, increasingly ti ... Learn more

An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration: Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug devel ... Learn more

Conducting Pharmacokinetic and Pharmacodynamic Studies: This course extends the learner's understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics ... Learn more

Drug Safety: Good Pharmacoepidemiology Practice: Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence o ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, 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 courses: 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
  • 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
  • Purchase orders (POs) accepted: If POs are required, 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
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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.

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