Length of Course: Approximate time to complete this course is 1.25 hour(s).
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
Training Program: Drug Safety: Risk Management Planning for Medicinal Products
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
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 in regions that are major markets for medicinal products.
This is an online training course offering immediate access upon enrollment. Username, password, and instructions will be emailed to the student immediately following an online enrollment. Programs may include 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.
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 Drug Safety: Risk Management Planning for Medicinal Products course is found in the following professional certification program(s):
Course overview - An outline of the course's scope and objectives, and notes on terminology.
Principles of risk management planning - In this session we set out principles of risk management planning as a major component of good pharmacovigilance practice. We discuss the modern emphasis on proactive risk management in addition to routine pharmacovigilance measures. We describe risk assessment factors important in safety specification, pharmacovigilance planning, and risk minimization for a drug. We then focus on the selection, implementation, and evaluation of non-routine risk minimization activities.
Regulatory requirements for risk management plans - In this session we outline regulatory requirements for risk management plans in regions that are major markets for medicinal products: Europe, the USA, and (in a brief sketch) Japan. We describe the structure, main components, and submission requirements for EU Risk Management Plans and US Risk Evaluation and Mitigation Strategies, and we sketch notable aspects of risk management requirements in Japan.
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 organisations should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.
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.