Last updated on: 26/06/2014
Name of organisation
1) Department/Research groupPharmacoepidemiology Research Group, Institute of Medical Informatics, Biometry and Epidemiology
2) Organisation/affiliationLudwig-Maximilians-Universitaet Muenchen
Short Name in the inventoryPharmacoepidemiology Research Group
Administrative Contact
Title Ms
Last name Rottenkolber
First name Marietta
Address line 1Fraunhoferstr. 12
Address line 2
Address line 3
CityPlanegg-Martinsried
Postcode82152
CountryGermany
Phone number (incl. country code)49-89-218072406
Alternative phone number
Fax number (incl. country code)49-89-218072404
Scientific Contact
Title Professor
Last name Hasford
First name Joerg
Address line 1Marchioninistr. 15
Address line 2
Address line 3
CityMunich
Postcode81377
CountryGermany
Phone number (incl. country code)49-89-4400-77480
Alternative phone number
Fax number (incl. country code)49-89-4400-77482
2. Description
The Pharmacoepidemiology Research Group was founded in the 1990ies at the Department for Medical Informatics, Biometry and Epidemiology, University of Munich, Germany. Major projects were the establishment of a network of regional pharmacovigilance centres, funded by the German drug authority BfArM, and a population-based study on drug use in pregnancy. PRG has gained considerable experience in drug utilisation research including persistence issues in asthma, hypertension and leukemia, the identification and validation of drug risks, the rapid response to sudden alerts, signal generation and consulting. The PRG is a member of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium) which is coordinated by the EMA.
The staff of the PRG is active in postgraduate training nationally and internationally.
The head of the PRG Prof. J. Hasford serves as Regional Editor for Europe of Pharmacoepidemiology and Drug Safety.
3. Category
University based
Hospital based
Government based
4. Available resources
In houseVia Contacts/Network
Epidemiologist/Pharmacoepidemiologist
Yes
No
Statistician
Yes
No
Clinician
No
Yes
Clinical Pharmacologist
Yes
No
Geneticist/Pharmacogeneticist
No
Yes
IT specialist
Yes
No
Ethics expertise
Yes
No
Legal expertise
No
Yes
Regulatory expertise
No
Yes
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Cardiovascular diseases
Geriatrics
Pregnancy
6. Design of drug safety/risk-benefit studies published in the past 5 years
Drug Utilisation
Hospital reimbursment data
7. Experience in collecting data directly from individual patients/respondents
None
8. Access to data collection resources
Capacity to conduct face-to-face interviews
No
Electronic data capture systems
Yes
System used:
VigilanceOne
Interactive voice response systems
No
Call centre
No
9. Experience in secondary research and meta-analysis
Yes
10. Work with existing data resources in the past 3 years
Name of data resourceNo. of studies
Hospital remuneration data2
Physician reimbursement data2
IMS disease analyzer1
11. Registries established by centre
Disease RegistryChronic Myeloid Leukemia
Other ADR registry
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
PROTECT
Other networks:
Network nameNationalInternationalLink to webpage
14. Interest in research opportunities which are funded
By pharmaceutical companies
By charities
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
Yes
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Stausberg J, Hasford J. Identification of adverse drug events: the use of ICD-10 coded diagnoses in routine hospital data. Dtsch Arztebl Int. 2010;107(3):23-9.
Hasford J, Uricher J, Tauscher M, Bramlage P, Virchow JC. Persistence with asthma treatment is low in Germany especially for controller medication –a population based study of 483051 patients. Allergy. 2009 Aug 27
Schmiedl S, Rottenkolber M, SzymanskiJ, Hasford J, Thuermann PA. Declining public health burden of digoxin toxicity: decreased use or safer prescribing? Clin Pharmacol Ther. 2009 FEB: 85(2):143-4; author reply 144.
Waller P, Beard K, Egberts T, Evans S, Hallas J, Hasford J, Laporte JR, Moore N, Shakir S, Sturkenboom M. European commission consultation on pharmacovigilance. Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):108-9.
Hasford J, Virchow JC. Excess mortality in patients with asthma on long-acting beta2-agonists. Eur Respir J. 2006 Nov;28(5):900-2.
