External databases - RWD - RWE

Let us guide you through the External databases - RWD - RWE 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. Have an overview of the FAERS database, particularly the FDA Adverse Event Reporting System (FAERS), Access to the system, Uses of FAERS, Interpretation of statistical safety signals, Strengths of the FAERS Database and Limitations of the FAERS Database
  2. Have an overview of the FDA Sentinel System, particularly on the current FDA Sentinel Monitoring System and the future FDA strategies to enhance Sentinel over the next 5 years
  3. Discuss new data sources for information on medicines consumption, describe some of these new data sources through a reflection based on a couple of practical examples and critically assess some advantages and biases of these kind of studies.
  4. Highlight the importance of how patients actually use medicines in the appearance of adverse drug reactions, discuss some examples showing the potentiality of analysing the characteristics of use of medicines, help you to identify potential sources of information on medicines use and discuss strengths, limitations and biases of different sources of information describing medicines use.

What will you learn

At the end of this module, the successful trainees should:

  • Be able to describe the FAERS database, explain how to access the FAERS database, enumerate the uses of the FAERS database, interpret safety signals derived from the FAERS database, describe strengths of the FAERS database and describe the limitations of the FAERS database
  • Be enable to understand the current system capabilities, become familiar with innovative approaches being undertaken to strengthen the system’s data infrastructure, become familiar with the effort to establish the Sentinel System as a multi-purpose national data and scientific resource center for evidence-generation that a wide array of stakeholders use to inform all aspects of healthcare decision-making
  • Know some biases and limitations of the traditional medicines consumption data sources, have revised a couple of examples describing studies conducting by using large databases, and know the practical application and present limitations of these calculations
  • Look at how patients are taking their medicines each time you assess any potential adverse drug reaction, identify when an inappropriate use of medicines can be the cause of an unnecessary adverse drug reaction and plan analyses of medicines utilization data sources in order to identify preventable adverse drug reactions

What’s included

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

What's the course content

FDA Adverse Event Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS)

  •  Award
  •  150 min
FDA Sentinel System

FDA Sentinel System

  •  Award
  •  150 min
Health care records from large databases as a tool to study the use of medicines

Health care records from large databases as a tool to study the use of medicines

  •  Award
  •  120 min
Integrating Pharmacovigilance and consumption data analysis - uses, limitations and potentiality

Integrating Pharmacovigilance and consumption data analysis - uses, limitations and potentiality

  •  Award
  •  120 min

Who is teaching you

Josep Maria Castel

Universitat Autònoma de Barcelona
Prof Albert Figueras

World Health Organization
Dr Sherael Webley

University of Hertfordshire
Roser Llop

Universitat Autònoma de Barcelona
Dr Dolores Rodriguez

Universitat Autònoma de Barcelona
Dr Veronique Kugener

Takeda
Dr Maribel Salas

Daiichi-Sankyo
Dr Abimbola Cole

Takeda
Nasop Experts Group

ISoP's North American chapter
Dr Sepideh Habibi

CRISPR Therapeutics
Dona Ely

Takeda

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 External databases - RWD - RWE!
  • 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!

Enrollment

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

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