Benefit Risk Assessment

Let us guide you through the Benefit Risk Assessment topic and get the necessary knowledge and skills to do it right

  •  Degree
  •  3 ects workload
  •  Intermediate level

The objective of this module is to provide you knowledge and understanding of the concepts and principles in pharmacovigilance globally with a focus in North America such as :

  1. The different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations.
  2. Insight in the changing health care environment and gives an overview of the different stakeholders that are involved in pharmacotherapeutic decision-making. Specific attention is given to the drivers and background of the different stakeholders and the rationale of benefit/risk and pharmacoeconomic evaluations in decision-making
  3. An overview and to define the concepts necessary to built a risk management plan for medicinal product.
  4. Define the general principles needed to build a process for developing Risk Management Plans for a medicinal product by the Industry. This course is based on the experience of a large international pharmaceutical company.
  5. An introduction to REMS principles, content, implementation, reporting and assessment, When a REMS is required and the Differences between REMS and RMP

What will you learn

At the end of this module, the successful trainees should be able to

  • Explain definition of benefit and risk in EMA framework, the rationale of BR frameworks and quantitative approaches in the process of decision-making (transparency, consistency, objectivity)
  • Distinguish the most important BR frameworks and their key components
  • Describe what BR Modeling and BR profiling is and define differences between these approaches and basic methods and outcomes of quantitative BR assessment and present merits and demerits of each approach
  • Have insight in the changing healthcare environment
  • Be able to delineate the process of decision-making and to explain the rationale of benefit-risk and pharmacoeconomic evaluation
  • Know the different stakeholders involved in the process of decision-making and be aware of the differences between key drivers of stakeholders
  • Be able to examine and demonstrate the viewpoint of a stakeholder in an example case
  • Master the definition of a risk related to medicinal product use, in particular versus toxicity, signal and benefit,
  • Define what risk management is, Understand the importance of risk perception and communication and Provide arguments for promoting the need for risk management
  • Understand the main principles for establishing a RMP process in a pharmaceutical company and how REMS are useful tools to reduce risk to patients from their medication
  • Know when FDA requires REMS, when REMS are tailored to the specific risk and can include one or more specified elements and when sponsors must report periodically to FDA on REMS effectiveness

What’s included

  • Videorecorded lectures
  • Lecture slides and supplemental reading materials
  • Discussions with experts
  • Progressive course assessment quizzes
  • Post Graduate degree in Benefit Risk Assessment issued by the 6 Eu2P academic partners
  • Access to a vast Am2P/Eu2P alumni student network

What's the course content

Principles and methods of benefit-risk assessment in decision-making of medicines

Principles and methods of benefit-risk assessment in decision-making of medicines

  •  Award
  •  120 min
Role of benefit-risk assessment and pharmaco-economics in decision-making of medicines

Role of benefit-risk assessment and pharmaco-economics in decision-making of medicines

  •  Award
  •  150 min
Concepts in Risk Management

Concepts in Risk Management

  •  Award
  •  180 min
Organization for risk management in the industry

Organization for risk management in the industry

  •  Award
  •  180 min
Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS)

  •  Award
  •  135 min

Who is teaching you

Dr Katia Verhamme

Erasmus Universitair Medisch Centrum
Prof Olaf Klungel

Universiteit Utrecht
Prof Hubert Leufkens

Universiteit Utrecht
Dr George Quartey

F. Hoffmann-La Roche Ltd
Dr Laurent Auclert

Sanofi-aventis Recherche et Développement
Prof Annalisa Capuano

Università degli Studi della Campania Luigi Vanvitelli
Dr Veronique Kugener

Dr John Price

Nasop Experts Group

ISoP's North American chapter

How does it work

  • Start an application file online, providing required academic information
  • You will be granted access to the online course area for a duration of 3 months and will follow the different course activities at your own pace
  • At the end of each course lessons, you will take a quiz exam and should score a minimum of 80% good responses. You should finalize all course lessons and succeed in all lesson quizzes within the 3 months course period to validate your training and be awarded with an academic Post Graduate degree in Benefit Risk Assessment!
  • In case of failure, you can review course activities and retake the final examination quizzes, as long as your 3 months active period is on!


Apply now and get access to the course for 3 months!

Status Base price Reward program* Partner saving*
Student 1,500 € / 1,750 $ up-to -20% -50 %
Professional 3,000 € / 3,500 $ up-to -20% -30 %
Groups Please contact us (price discounts based on group size, partner savings, and reward points)

*possible enrollment discounts are applied in the application cart