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Tuesday, December 11, 2018
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Drug Safety: Risk Management Planning for Medicinal Products (PV05)

Certification Training CPD Accredited TrainingCredits: 1.25 CPD Credits
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

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

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.

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.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, 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 training: 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
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The Drug Safety: Risk Management Planning for Medicinal Products course is found in the following professional certification program(s):


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


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


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.

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