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Home » Drug Safety: Risk Management Planning for Medicinal Products

Drug Safety: Risk Management Planning for Medicinal Products (PV05)

Certification Training
 
Rated 3.86/5
7 reviews
Method of Training: Online / Self-paced eLearning.
Credits: 1.25 CPD Credits.
Duration: ~1.25 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Drug Safety.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Drug Safety: Risk Management Planning for Medicinal Products
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE OUTLINE:


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.

COURSE OBJECTIVES:


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.

Objectives
  • Explain important principles of risk management planning
  • Give examples of risk minimization activities
  • Describe the selection of risk minimization activities that are proportional to a product's benefit/risk balance and do not impose undue burden on stakeholders
  • Outline regulatory requirements for risk management plans in regions that are major markets for medicinal products

The Drug Safety: Risk Management Planning for Medicinal Products Course is Included in the Following Professional Certification Programs:


Drug Safety and Pharmacovigilance Professional Certification Program: This professional certification program will provide the student with a comprehensive overview of the requirements and concepts necessary to attain a strong understanding of drug safety and pharmacovigilance. I ... Learn more

Good Pharmacoepidemiology Practice Professional Certification Program: This professional certification program will provide the student with a comprehensive overview of the requirements and concepts necessary for a strong understanding in good pharmacoepidemiology practice (GPP), ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • 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.
  • Purchase orders (POs) accepted: If 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.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

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.

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