8 May 2025

Big Data, Artificial Intelligence and Machine Learning in Drug Safety

Get an overview of data science methods in the context of drug safety. Learn how to critically assess scientific studies using big data. Gain competences within ethical, legal and regulatory aspects of big data and data science.

Big data, artificial intelligence and machine learning in drug safety

The need for competencies in Pharmaceutical Data Science is steadily increasing in response to the explosion of available and complex data in biomedicine and related streams.

The vast volume of data covers a diverse landscape from the properties of drug molecules over their biological mechanisms of action to individual patient data collected in clinical trials and healthcare settings.

Through this course you will get an overview of data science methods in the context of drug safety. The course is tailored for both academia and industry.

 

The topics of the course are:

  • Pharmaceutical data science for drug safety
  • Introduction to artificial intelligence, machine learning, and deep learning
  • Introduction to the Science of "Big Data"
  • Data sources and their characteristics, the possibilities for access
  • Case studies of applications of artificial intelligence, machine learning, and deep learning in drug safety
  • Regulatory and ethical aspects of using big data artificial intelligence in pharmaceutical science for drug safety

 

After completion of the course, you will be able to:

  • describe and explain the key sources of health data, and the context in which these data are collected, implications of the context on issues such as data quality, accessibility, bias, and the appropriateness of use to address specific research questions
  • discuss different analytical approaches and limitations of data sources and methods
  • understand the fundamentals of data science with a focus on pharmaceutical data science
  • understand the roles of a pharmaceutical data scientist within the wider pharmaceutical research environment
  • interpret and critically assess scientific studies and other types of information produced using big data and data science methods
  • reflect on ethical, legal and regulatory aspects of big data and data science

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Participants must meet the following criteria

  • Hold a relevant bachelor degree or equivalent
  • Have a minimum 2 years of relevant job experience
  • Be proficient in English

Find detailed information about the admission criteria.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Course responsible
Morten Andersen, Professor, Department of Drug Design and Pharmacology, University of Copenhagen.

Lecturers
Morten Andersen, Professor, Department of Drug Design and Pharmacology, University of Copenhagen.
Maurizio Sessa, Assistant professor, Department of Drug Design and Pharmacology, University of Copenhagen.

Other guest lecturers
Professionals from safety / epidemiology / pharmacovigilance departments in the pharmaceutical industry and
regulatory agencies.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This course is offered as an elective course in Master of Industrial Drug Development and Master of Medicines Regulatory Affairs.

Priority is given to students enrolled on Master of Industrial Drug Development or Master of Medicines Regulatory Affairs.

Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.

 

 

 

 

 

 

 

 

 

 

 

 

Course details

Duration: 1 + 5 days over a period of 2 weeks 
Dates: Currently not available. Expected to be offered in spring 2025
Place: Atrium, Copenhagen, Denmark
Course fee:
EU/EEA citizens: 30,000 DKK
Non-EU/EEA citizens: 33,475 DKK
The fee includes lunch/coffee.
Level and credit: Master course; 5 ECTS
Examination date: Please consult the exam schedule
Application deadline: 6 weeks prior to course start
Admission: To be admitted, you must meet the admission criteria for Master of Industrial Drug Development


Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum