Master’s studies

Preclinical Safety Assessment and Pharmacovigilance 2017/2018 (7.5 credits)

Autumn 2017 weeks 35-43 (September - November) - Mixed - 50 % - Distance learning

Application Deadline: 2017-04-18

Enrolment Code: UU-38505 Application

Language of Instruction: English

Location: Flexible

Selection: Higher education credits

Outline for distance course: The course is entirely web-based and contains no compulsory campus meetings. Lectures are recorded and organised as video/audio sessions and are available on a web-based teaching platform. The students are offered supervised studies via the same teaching platform. This platform is also used for individual assignments, group exercises and discussions. Some of these assignments and exercises are mandatory and the participants are offered general or individual feedback on these moments. The participants and teachers communicate via the website and via e-mail. A forum for discussion is also available. Examination will be in the form of web-based tests or individual assignments. In order to participate in this course you must have access to a computer with Internet connection, headset with microphone and programs such as Adobe Flash/Connect have to be installed.

Spring 2018 weeks 03-12 (mid-January - April) - Mixed - 50 % - Distance learning

Application Deadline: 2017-10-16

Enrolment Code: UU-88505 Application

Language of Instruction: English

Location: Flexible

Selection: Higher education credits

Outline for distance course: The course is entirely web-based and contains no compulsory campus meetings. Lectures are recorded and organised as video/audio sessions and are available on a web-based teaching platform. The students are offered supervised studies via the same teaching platform. This platform is also used for individual assignments, group exercises and discussions. Some of these assignments and exercises are mandatory and the participants are offered general or individual feedback on these moments. The participants and teachers communicate via the website and via e-mail. A forum for discussion is also available. Examination will be in the form of web-based tests or individual assignments. In order to participate in this course you must have access to a computer with Internet connection, headset with microphone and programs such as Adobe Flash/Connect have to be installed

Entry Requirements: University education equivalent to at least 180 credits (i.e. three years of full-time studies) in pharmacy, pharmaceutical science, medical science, veterinary medical science, biomedicine or chemical engineering focusing on pharmaceuticals; the education should include biomedical courses such as physiology, biochemistry, cell/molecular biology, and must include a course in pharmacology or toxicology. All applicants need to verify English language proficiency. This is normally verified by means of an internationally recognised test such as TOEFL or IELTS.
Admitted to the Master Programme in Drug Mangement or to the Masterprogramme in Drug Discovery and Development.

Fees:

If you are not a citizen of a European Union (EU) or European Economic Area (EEA) country, or Switzerland, you are required to pay application or tuition fees. Formal exchange students will be exempted from tuition fees, as well as the application fee. Read more about fees.

Application Fee: SEK 900

Tuition fee, first semester: SEK 18125

Tuition fee, total: SEK 18125

Please note: The course is given in collaboration with the Uppsala Monitoring Centre (UMC). UMC is responsible for the management of the WHO Programme for International Drug Monitoring and the WHO Global ICSR Database. 

About the course:

This introductory course provides a concise overview on principles of preclinical safety assessment and pharmacovigilance. We will discuss the assessment of drug candidates,  risk/benefit profiling of drugs and the safe use of medicines. The course is suitable for those who want to work with preclinical toxicity testing or adverse drug reaction reporting and pharmacovigilance.

The course will focus on principles of

  • Preclinical toxicity testing
  • Mechanisms of toxicity and adverse drug reactions
  • Risk/benefit assessments of drug candidates and pharmaceutical drugs
  • Adverse event reporting and methods in pharmacovigilance
Drug safety encompasses safety aspects in all phases of drug development and drug use. We will discuss the safety of drug candidates and pharmaceutical drugs based on toxicological testing as well as on clinical trials. Pharmacovigilance is based on the assessment of spontaneous reports of adverse events and signal detection. Please note that the course will not cover the detailed toxicity testing and pharmacovigilance guidelines and regulations set up by EMA and FDA, the web-based pharmacovigilance tools set up by these agencies. Furthermore, the course will not cover cover detailed regulations for adverse event reporting within pharmaceutical companies.

More information

Contact

Department of Pharmaceutical Biosciences

Uppsala biomedicinska centrum BMC, Husarg. 3

Box 591, 751 24 UPPSALA

Telephone: 018-471 4010