Drug Safety and Pharmacovigilance
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Download 2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline: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. | 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 | |
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Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs. |
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| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
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