Introduction to Drug Safety and Pharmacovigilance (AV02)

Online training with immediate access upon enrollment.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence 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 / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

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 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. With its advanced learning techniques, the BioPharma Institute 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 BioPharma Institute 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) 424-6576 or send us an email at support@biopharmainstitute.com for more information.

The Introduction to Drug Safety and Pharmacovigilance 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:

Course overview - Describes what the course is about, sets out learning objectives, defines key terms and provides a brief overview of course content.

Regulation and company organisation - 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 organisation, 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, licence holders' reporting requirements, detecting and testing safety signals, assessing benefit/risk balance, risk minimization, communicating new safety information, product withdrawal.

Quality system, inspections and audits - Describes measures, increasingly emphasized by regulators, to ensure adequate performance of a PV system: the organisation's PV quality system, regulatory inspections, and audits.

Review and further information - Summaries key points and provides links to important guidance documents and other reference sources.

Assessment - Multiple-choice mastery assessment.

COURSE OBJECTIVES:

Who will benefit from this module?
Entry-level staff, and those seeking a refresher, in drug safety / pharmacovigilance and clinical departments will find the course invaluable, as will clinical investigators and other healthcare professionals. Staff in other departments of pharmaceutical and biotechnology companies will benefit from taking the course to gain an appreciation of the basics of the subject.

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 organised 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.