Medicademy - Medicademy Pharmacovigilance Module 7. Adverse Drug Reactions by Body Systems

Medicademy Pharmacovigilance Module 7. Adverse Drug Reactions by Body Systems

Registration deadline:
5 January 2013

Exam:
TBD

Please remember that you can take the exam in your own country. Further information on the exam will follow.

Please note: The course design of Medicademy Pharmacovigilance is highly flexible, and each module is a complete module, which can either be taken as an individual module or as one module in a series of modules - and in any arbitrary order.

	Register Medicademy Pharmacovigilance Module 7. Adverse Drug Reactions by Body Systems
Price: DKK 17,000.00 VAT, 25% DKK 4,250.00 Incl. VAT DKK 21,250.00

Startdate:
5 February 2013 - 7 February 2013

Location:
Medicademy
Lersø Parkallé 101
2100 København Ø

Purpose:
By the end of this module, the student should be able to:

Understand the clinical manifestation of ADR in different organ systems

Analyse and evaluate the clinical consequences of drug use and the ADR risk, be able to incorporate pharmacokinetic variance, drug-drug interactions, and pharmacogenetics in the context of ADR risk assessment

Use and conduct causality assessments and evaluate reports, scientific as well as clinical papers, be able to operate in complex and unpredictable context, and form a comprehensive view of good pharmacovigilance practice

Content:

- Interactions and real risk for ADR
- Biomakers in clinical development and for ADR predictions
- Pharmacokinetics and pharmacodynamics with focus on ADR
- Classification system for ADR

- Drug-induced:
     *blood and bone marrow disorders
     *respiratory tract damage and reactions
     *skin reactions
     *confusion and cognitive disturbance induced by ADR
     *renal symptoms of ADR, and ADR due to renal insufficiency
     *liver function changes and impairment
     *gastro-intestinal damage and manifestations
     *muscular/bone symptoms and damage
     *cardiovascular symptoms and damage

- Cytotoxic induced disorders
- Pharmacogenetic impact for ADR
- ADR in drug-treated HIV-seropositive patients

Course leaders:
Jesper Hallas, University of Southern Denmark, Denmark
Per Hartvig Honoré, University of Copenhagen, Denmark

Lecturers:
The Medicademy pharmagovigilance faculty employs lecturers from all over Europe, including the pharmaceutical industry, the EMA, national authorities, universities and organisations. All lecturers work within their teaching area and are experts within their field.

Prerequisites:
The recommended entry qualifications of participants are two years of experience within Pharmacovigilance or similar entry qualifications. Please note that applications will be reviewed on a first come first served basis.

Other participants will be considered on a case-by-case basis.

Mail us for more information

Plads til diskussion – rigtig godt

Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer

Minna K. Jørgensen

Minna Kjær Jørgensen is Program Director, Medicademy Pharmacovigilance and also responsible for Introduction to Safety & Pharmacovigilance and Medical Advertising Standards.

mkj@dli.dk

Phone: +45 39 15 09 28

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