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Fundamentals of register-based pharmacoepidemiology: evidence synthesis, data sources, and study design
Provider: Faculty of Health and Medical Sciences

Activity no.: 3480-21-00-00 
Enrollment deadline: 17/08/2021
Date and time01.11.2021, at: 08:00 - 05.11.2021, at: 13:00
Regular seats20
Course fee5,520.00 kr.
LecturersMorten Andersen
ECTS credits3.70
Contact personMarianne Jørgensen    E-mail address: marianne.joergensen@sund.ku.dk
Enrolment Handling/Course OrganiserPhD administration     E-mail address: fak-phdkursus@sund.ku.dk

Aim and content
This course is free of charge for PhD students at Danish universities (except Copenhagen Business School), and for PhD students at graduate schools in the other Nordic countries. All other participants must pay the course fee.
Anyone can apply for the course, but if you are not a PhD student at a Danish university, you will be placed on the waiting list until enrollment deadline. This also applies to PhD students from Nordic countries. After the enrollment deadline, available seats will be allocated to applicants on the waiting list.

Learning objectives
A student who has met the objectives of the course will be able to:

1. Search, evaluate, and organize available evidence on a research topic objective of a register-based study.
2. Identify registers available in Denmark relevant for pharmacoepidemiological research.
3. Recognize Danish laws and regulations on register-based data.
4. Plan and design a pharmacoepidemiological study using register-based data.
5. Define exposures, outcomes, and auxiliary variables in register-based data.
6. Perform basic data management procedures on simulated registers-based data.

The students are expected to obtain an epidemiologic competence which makes them able to contribute to planning and carrying out epidemiological studies based on register data. In particular, the course will provide knowledge and skills on four key aspects of register-based research: 1) evidence synthesis, 2) selection of data sources, 3) plan of a pharmacoepidemiological study and 4) data management. Evidence synthesis is a key part of register-based research as it guarantees a transparent and reproducible report of available evidence on the research topic under investigation. The participants will learn how to develop structured and reproducible search strategies to retrieve available evidence on their research topic. Additionally, they will learn how to evaluate and process search results. In the second part of the course, participants will learn which data sources are available in Denmark to conduct register-based research. A wide range of national and regional data sources available on drug dispensing, biomarkers, health outcomes, and socioeconomic status will be presented and so will the processes when linking data from various sources. Additionally, the participants will have the possibility of learning the basic principles of pharmacoepidemiological study design, and data management of register data using simulated datasets. In particular, the participants will be trained to develop part of a study protocol with a focus on the choice of available study design and operationalization of epidemiological concepts in algorithms for defining exposures, outcomes, and auxiliary variables in Danish register data.

The maximum number of participants is 20. The course is open for PhD students and junior researchers. Students from outside the Nordic countries can also apply. All applicants must have basic and documented skills in using statistical software (SAS, Stata, or R) for data management, and have - at a minimum - basic level knowledge in epidemiology.

Relevance to graduate programmes
The course is relevant to PhD students from the following graduate programmes at the Graduate School of Health and Medical Sciences, UCPH:

Pharmaceutical Sciences (Drug Research Academy)
Public Health and Epidemiology
Biostatistics and Bioinformatics

The course will be in English

The course will include lectures, group work, and exercise classes. It is compulsory to participate in individual work and group work. Any absence will have to be compensated by extra individual assignments outside the course periods and provided by the course organizers. The examination will be performed as an oral and written presentation of group work. Additionally, each student will be assessed individually.

Course director
Assist. Prof. Maurizio Sessa (co-director), Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen - maurizio.sessa@sund.ku.dk
Prof. Morten Andersen (co-director), Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen - morten.andersen@sund.ku.dk

Assist. Prof. Maurizio Sessa MPharm, PhD, Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen - maurizio.sessa@sund.ku.dk
Prof. Morten Andersen, Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen - morten.andersen@sund.ku.dk
Mikkel Porsborg Andersen, MScPH, PhD, Department of Clinical Research, Nordsjaellands Hospital - mikkel.porsborg.andersen@regionh.dk
Professor Anders Hviid, Department of Drug Design and Pharmacology, University of Copenhagen and Statens Serum Institut - aii@ssi.dk

1-5 November 2021
Monday-Thursday 8-16, Friday 8-13

Course location
TBA, PharmaSchool, Universitetsparken 2/Jagtvej 160, 2100 Copenhagen

Please register before 17 August 2021.
Seats to PhD students from other Danish universities will be allocated on a first-come, first-served basis and according to the applicable rules.
Applications from other participants will be considered after the last day of enrolment.

Note: All applicants are asked to submit invoice details in case of no-show, late cancellation or obligation to pay the course fee (typically non-PhD students). If you are a PhD student, your participation in the course must be in agreement with your principal supervisor.

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