Enrollment Period: 6 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1.5 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Drug Safety.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $195.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: Drug Safety: Signal Detection and Management in Pharmacovigilance
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
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 account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.
Product license holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance, and they take risk minimization action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources.
The methods used range from traditional medical assessment of individual spontaneous reports of adverse events, through 'data mining' of large databases, observational studies of 'real world' prescription and use, to interventional clinical trials.
This course provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four (4) stages: signal detection, signal validation, signal analysis and prioritization, and risk assessment and minimization.
This online course supplies the student with a guide that will help them understand signal detection and the proper management of approved products. The process for this subject matter is presented in four stages: minimization and risk assessment; prioritization and signal analysis; signal validation; and signal detection. Interventional clinical trials, observational studies of prescription, and their use in the real world, data mining through large databases, and traditional medical assessment of individual spontaneous reports of adverse events, are some of the methods used.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
Module overview - This session provides an outline of the course's scope and objectives, and notes on terminology. It also defines safety signal and explains our approach to the signal detection and management process.
Signal detection - The question addressed in this session is: 'Are there data that may indicate a safety signal?'. The various sources of safety signal-relevant data are set out. 'Traditional' signal detection by qualitative review of individual case reports is described, followed by a discussion of quantitative analysis of aggregate data on drug-event associations to detect signals of disproportionate reporting, a process known as 'data mining'.
Signal validation - The question addressed in this session is: 'Is there a safety signal?'. Steps taken to determine our degree of confidence in the existence of a signal are described. The development of a case series is outlined, and qualitative clues to causality are listed. Approaches to estimation of the incidence of the adverse event(s) in the exposed population are described: including crude approximation of reporting rate, and active surveillance through cohort/prescription-event monitoring and observational study in registries.
Signal analysis and prioritization - The question addressed in this session is: 'How important is the signal, and do we know enough about it?'. Factors that increase the priority assigned to a signal are listed. The consequences of assignment of a category of risk are outlined. Further investigation of a signal through controlled research, in the form of pharmacoepidemiological studies or clinical trials, is described, and factors influencing a decision to undertake such an investigation are set out.
Risk assessment and minimization - The question addressed in this session is: 'How does the signal affect benefit/risk balance, and what do we need to do about it?'. Factors affecting re-assessment of the benefit/risk profile of a product in the light of verification of a previously unexpected reaction are set out. Possible risk minimization actions are listed. Requirements for reporting to regulatory authorities are described, and advice is given on communicating safety information to healthcare professionals and consumers.
Assessment - Multiple-choice mastery assessment.
Who will benefit from this module?
All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies or contract research organizations should have access to this course. It will also be of value to healthcare professionals and regulatory authority personnel.
Drug Safety: Signal Detection and Management in Pharmacovigilance is included in the following professional certification programs:
Price: $695.00 (USD) | Learn more
Price: $995.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- Purchase orders (POs): If issuing a PO is required by your company, 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.
- Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.