Go to the newsletter page and sign up to receive course dates, call for applications and other related programme news.
Pharmacoepidemiology and Postauthorisation Safety Studies
Learn the principles of pharmacoepidemiology, data sources, post-approval safety studies (PASS) and related international legislation and guidelines.
This course is a part of
During this course, you will get a thorough insight into the principles of pharmacoepidemiology, data sources and the regulations, practice and processes related to post-approval safety studies (PASS).
This deals with both the regulatory authorities, the pharmaceutical industry and other partners involved in PASS.
The aim of the course is to give you knowledge about the principles of pharmacoepidemiology and the scientific and regulatory aspects of post-approval safety studies, PASS.
This course guides you through the different types of evidence produced by pharmacoepidemiological studies of adverse drug effects. We will go through the strengths and weaknesses of different study designs and methods.
You will learn to choose design and data sources that best fit the purpose of study, and to critically evaluate published literature on drug safety.
Lectures are supplemented with group discussions based on real and simulated safety scenarios and scientific literature.
Prior to the course commencement, you may take part of some voluntary online theory exercises.
Course topics
The topics of the course are many, and cover the entire area of pharmacoepidemiology:
Pharmacoepidemiological methods
- Measures of occurrence and effect
- Cohort and case-control study designs
- Sources of error, bias and confounding
- Basic statistical concepts in epidemiology
- Analysis of epidemiological studies
- Drug utilisation studies and quality indicators of drug use
- Interpretation of study results, strengths and limitations
Data sources for post-approval studies
- Primary and secondary data collection (healthcare databases)
- Completeness, quality and validity of data
- Choice of data for randomized clinical trials, low- and non-interventional studies
- Data protection regulation, ethics and confidentiality
Post-approval safety studies (PASS)
- The role of pharmacoepidemiological studies in pharmacovigilance and risk management
- Regulatory processes and decisions involving PASS including the role of regulatory bodies (EMA, PRAC and CHMP, FDA)
- Legislation, guidelines and methodological standards of PASS
- Planning and conducting a PASS
- The study protocol and the study report
Course Director and Lectures on Pharmacoepidemiology and Postauthorisation Safety Studies
Course details: Pharmacoepidemiology and Postauthorisation Safety Studies
Dates and examination
Course dates
To be announced.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Industrial Drug Development.
Learning outcomes
After completion of the course, you will be able to:
- Describe, analyse and interpret the results of pharmacoepidemiological studies.
- Describe and assess the limitations of data and methods in published literature and safety reports.
- Summarise and prioritise safety information obtained with different methods in a structured way.
- Independently develop a protocol and plan for a post-authorisation safety study applying the gained knowledge.
- Review, interpret and assess safety data obtained in pharmacoepidemiological studies.
- Assess benefit/risk, integrating results from post-approval safety studies (PASS) and other safety information.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience in drug development
- Be proficient in English
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as an elective course in the Master of Industrial Drug Development and Master of Medicines Regulatory Affairs. Priority is given to students already enrolled in either of the two master programmes. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
EU/EEA citizens: 30,000 DKK
Non-EU/EEA citizens: 33,555 DKK
Early Bird: Register by 27 March 2024 and save DKK 3,000 on the price above.
The fee includes lunch/coffee.
Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66