Big Data, AI, and Machine Learning in Drug Safety

How can data science methods contribute in securing drug safety?

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No available dates
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On location

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English

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30,000 DKK ex VAT

Summary

In this five-day course, developed in collaboration with the University of Copenhagen, you gain knowledge and insights you can translate into action in your role as a pharmacovigilance professional responsible for taking advantage of the possibilities inherent in big data, AI, and machine learning. For today’s pharmacovigilance professionals, it is necessary to be capable of using the data science toolbox. But how do we choose the right data for our specific objective? And how do we collect and process data in a way that considers the ethical, legal, and regulatory aspects of big data and data science?

The number of signals is continuously increasing. This course provides an overview of AI and how technologies like this can be applied to better understand safety and adverse events. You’ll learn to use these tools effectively to benefit patients and enhance your studies.

A key focus is how to identify the most important signals—the relevant, actionable signals. With the volume of data available, it’s easy to feel overwhelmed. This course will help you distinguish between noise and true value.

You will gain a fundamental understanding of data science that will support you in making better-informed decisions based on comprehensive data analysis. In addition to theoretical insights, we will discuss practical examples, including best practices and common pitfalls.

The course begins with a two-week online component, equivalent to one day of work, followed by a 5-day in-person session.


    Keywords

    • Big data
    • Artificial Intelligence
    • Machine learning
    • Drug safety
    • Data science

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    Course leader & lecturers

    • Faisal M. Khan
      Course leader
      CVP, Advanced Analytics, AI & RWD
      Novo Nordisk A/S
    • Maurizio Sessa
      Course leader
      Associate Professor in Pharmacoepidemiology
      Københavns Universitet
    • Morten Andersen
      Course leader
      Professor in Pharmacovigilance
      University of Copenhagen
    • Andrew Bate
      Lecturer
      VP and Head, Safety Innovation & Analytics, Global Safety, GSK
      GSK, UK
    • Rune Klingenberg Hansen
      Lecturer
      M.Sc., Ph.D. (ethics)
      Nationalt Center for Etik
    • Jonna Skov Madsen
      Lecturer
      Professor
      Sygehus Lillebælt, Syddansk Universitetshospital
    • David Gloriam
      Lecturer
      Professor, Department of Drug Design and Pharmacology, University of Copenhagen
      Københavns Universitet, SUND
    • Albert Jelke Kooistra
      Lecturer
      Associate Professor,Department of Drug Design and Pharmacology, University of Copenhagen
      Københavns Universitet, SUND
    • Jason Bryant
      Lecturer
      AI engineer
      ArisGlobal LLC
    • Mohan Kumar Adisesha
      Lecturer
      Data Scientist
      ArisGlobal LLC
    • Esben Jannik Bjerrum
      Lecturer
      PhD
      Cheminformania Consulting
    • Jan Petracek
      Lecturer
      MD, Chief Executive Officer
      iVigee Services a.s.
    • Per Råberg Naglbøl
      Lecturer

      Novo Nordisk A/S
    • Tove Holm-Larsen
      Lecturer
      CEO
      Pharmaevidence
    • Philip Sheridan
      Lecturer

      Oracle Health Science
    • Lucie Gattepaille
      Lecturer
      Head of Data Science
      Uppsala Monitoring Centre
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    Is this course for you?

    This course is relevant for all experienced pharmacovigilance professionals, e.g. safety surveillance advisers, safety scientists, patient safety associates, data science professionals, and employees of The Danish Medicine Agency.

    What you will learn

    1. To understand different analytical approaches, and the limitations of data sources and methods.
    2. To discuss the results of scientific studies and other information obtained using big data and data science methods.
    3. To interpret and critically assess scientific studies and other types of information produced using big data and data science methods.
    4. To discuss ethical, legal, and regulatory aspects of big data and artificial intelligence.

    What your company will get

    1. An employee who knows the fundamentals of data science, and how to translate them into practice.
    2. An employee who knows the key sources of health data and issues such as data quality, accessibility, and bias.
    3. An employee who understands the appropriateness of different data types to address specific research questions.
    4. An employee who understands key issues related to ethics, data security, confidentiality, and information governance.

    Course information

    Literature

    Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.

    Examination

    The exam is held online, usually 4-6 weeks after the course.

    You will receive a link with exam questions via your personal Atrium log-in.

    To participate in the exam, you must have attended the course.

    This course is a part of a diploma

    Diploma in Pharmacovigilance

    The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Diploma in Pharmacovigilance.

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    Course leaders

    Faisal M. Khan
    CVP, Advanced Analytics, AI & RWD
    Novo Nordisk A/S
    Maurizio Sessa
    Associate Professor in Pharmacoepidemiology
    Københavns Universitet
    Morten Andersen
    Professor in Pharmacovigilance
    University of Copenhagen

    Lecturers

    Andrew Bate
    VP and Head, Safety Innovation & Analytics, Global Safety, GSK
    GSK, UK
    Rune Klingenberg Hansen
    M.Sc., Ph.D. (ethics)
    Nationalt Center for Etik
    Jonna Skov Madsen
    Professor
    Sygehus Lillebælt, Syddansk Universitetshospital
    David Gloriam
    Professor, Department of Drug Design and Pharmacology, University of Copenhagen
    Københavns Universitet, SUND
    Albert Jelke Kooistra
    Associate Professor,Department of Drug Design and Pharmacology, University of Copenhagen
    Københavns Universitet, SUND
    Jason Bryant
    AI engineer
    ArisGlobal LLC
    Mohan Kumar Adisesha
    Data Scientist
    ArisGlobal LLC
    Esben Jannik Bjerrum
    PhD
    Cheminformania Consulting
    Jan Petracek
    MD, Chief Executive Officer
    iVigee Services a.s.
    Per Råberg Naglbøl

    Novo Nordisk A/S
    Tove Holm-Larsen
    CEO
    Pharmaevidence
    Philip Sheridan

    Oracle Health Science
    Lucie Gattepaille
    Head of Data Science
    Uppsala Monitoring Centre

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    Want to know more, or need help?

    Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

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