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Tuesday, January 22, 2019
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An Introduction to Drug Safety and Pharmacovigilance (DS01)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: An Introduction to Drug Safety and Pharmacovigilance
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. 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 tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety (or pharmacovigilance). It is important that all staff are aware of the basic requirements. This course will provide those enrolled with an overview of the most important aspects of this discipline, both before and after marketing of products. The course details how these apply most specifically in Europe and the USA.
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 An Introduction to Drug Safety and Pharmacovigilance course is found in the following professional certification program(s):


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COURSE OUTLINE:


Orientation
Designed as an introduction to using the Zenosis courses, this session guides you through the different functions of The course interface, such as how to navigate and interact with the course material. Also provided are short tips on how to get the most from your e-learning experience.
Introduction
Describes what the course is about, sets out learning objectives, defines key terms and provides a brief overview of course content.
Regulation and company organization
Explains the rationale for modern drug safety / pharmacovigilance (PV) regulation and practice, describes international policy-making bodies and sources of regulatory guidance, and outlines company drug safety / PV organization, product safety databases and core safety information.
Before a product is marketed
Sets out the fundamentals of pre-marketing drug safety / PV: safety information for investigators, describing adverse effects, clinical trial reporting requirements, safety data in marketing applications, risk management planning, and product information.
After a product is marketed
Sets out the fundamentals of post-marketing PV: monitoring adverse drug reactions, license holders’ reporting requirements, detecting and testing safety signals, assessing benefit/risk balance, risk minimization, communicating new safety information, product withdrawal.
Review and further information
Summarizes key points and provides links to important guidance documents and other reference sources.
Assessment
Multiple-choice mastery assessment.

COURSE OBJECTIVES:


Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary
Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies
Outline how drug safety / pharmacovigilance responsibilities are organized within pharmaceutical and biotechnology companies
Sketch how a product safety database is compiled, how a product’s safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers
Apply appropriate terms to describe different types of adverse effect
Specify requirements to report adverse reactions to regulators
Outline requirements for safety data and for risk management plans in applications for marketing approval
List tasks involved in monitoring adverse reactions to marketed products, and sketch how safety signals are detected and tested
Identify factors that influence the evaluation of a product’s benefit/risk balance, and list actions that may be taken in response to changes in the balance


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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