Introduction to Drug Safety and Pharmacovigilance (AV02)
 | 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 
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 Training Program: Introduction to Drug Safety and PharmacovigilanceTraining 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 / 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. 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 Introduction to Drug Safety and Pharmacovigilance course is found in the following professional certification program(s):
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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, license 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
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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.
