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Tuesday, June 27, 2017
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Introduction to Drug Safety and Pharmacovigilance (AV02)

Certification Training Duration: 1.9 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $189.00

dinaris.org LogoTraining Program: Introduction to Drug Safety and Pharmacovigilance
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

Risk management and drug safety monitoring are exceedingly important for clinical investigators, license holders, and medical product developers. Potentially massive payments to litigations and increasingly tight regulation provide strong incentives for biotechnology and pharmaceutical companies to ensure that they maintain efficient systems for pharmacovigilance, or drug safety. It is vital that appropriate staff members be familiar with these most basic requirements. This course provides students with a look at the essential aspects of this discipline – both before and after product marketing. The course also discusses how these specifically apply in the USA and in Europe.

This is an online training course with immediate access upon online enrollment. Username, password, and instructions will be immediately emailed to the student following an online order. 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 take the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. With its advanced learning techniques, the dinaris.org uses proven methods to assist professionals and corporations with maintaining training records, educating employees, and offering an overall improvement in the quality of service you offer. The dinaris.org has the course content and the experience required to deliver the high-quality training to your employees, you, and your colleagues. This will help to achieve professional objectives, further careers, and assist with continued success.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at 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, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Introduction to Drug Safety and Pharmacovigilance Course is Found in the Following Professional Certification Program(s):


Adverse Event Reporting 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- specifically, adverse e … Learn more

COURSE OUTLINE:


Orientation
Designed as an introduction, 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

JOB POSTINGS:

1270 Drug Safety jobs found.
Displaying jobs #1-4.

Safety Engineer – Reading, PA
Posted Date: 2017-06-24
Carpenter Technology – United States, PA, Reading, 19610

Security Officer Guardian Safety Division
Posted Date: 2017-06-23
Allied Universal – United States, CO, Lakewood,

Security Officer Community Safety Division
Posted Date: 2017-06-23
Allied Universal – United States, CA, Cypress, 90630

Security Officer Concierge Safety Division
Posted Date: 2017-06-23
Allied Universal – United States, CO, Lakewood,

See more Drug Safety Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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