Report from the

WHO Collaborating Centre

for International Drug Monitoring
Activities July 2008 – June 2009
1. Introduction
The activities of the WHO Collaborating Centre for International Drug Monitoring (also called
the Uppsala Monitoring Centre, UMC) are based on an agreement dating from 1978, updated in
December 2001, between the World Health Organization and the Swedish Government.
The Centre is a foundation headed by a board of six members with personal deputies, three
appointed by the Swedish government, three appointed by WHO. In January 2007 the board
was reassigned for a new three-year period. Chairman of the board is Mr Carl Älfvåg, Director
General at Handisam (Swedish Agency for Disability Policy Coordination).

2. Administration
Director of the Centre (until 31 August 2009) was Professor Ralph Edwards. During the period
July 2008 – June 2009 Marie Lindquist was General Manger, Chief Scientific Officer and
Deputy Director. The organization is managed by a Steering Committee for strategic planning
and an Executive Committee (EC) for the day-to-day management. The EC consists of the
Director, General Manager, Deputy Director and the department Managers.
Dr Ronald Meyboom served as a medical adviser working part-time at the UMC. At the end of
the period UMC had around 70 employees, of whom five were on parental or study leave.
Funds for operation of the Centre, in the order of 100 million Swedish Kronor, were raised
through the provision of products and services to paying clients. Supply of the WHO Drug
Dictionary to the pharmaceutical industry accounted for approximately 95% of these receipts.
Other income sources are training and other services and consultancies to paying customers.

3. Member countries
Several countries became full members of the WHO Programme during the period of this
report, taking the total to 95. They were: Kazakhstan, Barbados, Andorra, Sierra Leone,
Ethiopia, Sudan, Saudi Arabia, Namibia, Botswana, Madagascar, Senegal. A new Associate
member, awaiting full membership status, was Iraq.
In January 2009 the UMC published and circulated a short booklet for member countries
describing the benefits and responsibilities of membership of the WHO Programme, entitled
Being a Member of the WHO Programme for International Drug Monitoring.

4. Adverse reaction reporting

The main focus for the Reporting Team has been continued harmonization of the internal
processes of the Individual Case Safety Reports (ICSRs). This included conversion of INTDIS
cases (ICSRs in old WHO format) to the international ICH-E2B format as well as extended
interpretation of the ‘world wide unique id’ on ICH-E2B cases. The reason behind the
harmonization is to facilitate both the handling and interpretation of case safety data in
VigiBase. The harmonization process also detected around 4,000 duplicate cases in VigiBase
and these were ‘history marked’ during the summer of 2009.
Administration procedures within the Reporting Team have decreased dramatically since the
introduction of an internal upload tool for ICSRs. The future plan is to offer this tool to
National Centres so they may upload ICSRs themselves instead of sending e-mails with attached
file(s).
Another focus has been European Union member countries that are obliged to send ICSRs to
both EMEA and the UMC. Problems identified are technical difficulties and duplication of
work due to non-harmonized processes when submitting cases to both organizations. Due to a

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decrease in reporting from many of these countries a survey is planned for September 2009.
With the information collected from this survey, the UMC aims to facilitate and improve the
reporting of ICSRs to the UMC.
During the period 656,465 ICSRs were processed (83 out of 95 member countries contributed).
By the end of June 2009, VigiBase held more than 4.7 million active ICSRs.

5. Feedback of information to National Centres

5.1 Output from VigiBase
VigiSearch is a free web-based service for national centres for retrieving information from
VigiBase (https://vigisearch.who-umc.org). Since November 2008 the statistical tool VigiMine
is also available to the National Centres via this site and provides statistical data that were
previously sent out on CD with the Combinations Database, for example IC values (a statistical
measure of the disproportionality of reporting on a specific drug-ADR combination).
Furthermore, VigiMine also includes several filtering possibilities, stratified statistics and is
updated monthly. VigiSearch and VigiMine are available in both WHO-ART and MedDRA
terminology. By the end of the report period 93 countries had requested and received access to
this tool, an increase of 38% from the previous year.
In addition to the online access all National Centres are welcome to request ad hoc searches in
the database, and during the specified period the UMC performed some twenty such searches.
Member countries are also provided quarterly with updates of the WHO Drug Dictionary and
WHO-ART in computer files.
5.2 Newsletters
The UMC contributed background information for the WHO Pharmaceuticals Newsletter produced
by the Quality Assurance and Safety of Medicines (QSM) team at WHO Headquarters. This
publication is distributed to drug information officers in WHO member states and other
interested parties around the world, either electronically or printed, and is available from the
WHO web site. Seven issues were published during the period.
An agreement with publishers Adis International Inc allowed National Centres to subscribe to
the journal Reactions Weekly at a reduced rate through the UMC. By the end of this period 38
countries were benefiting from this reduction. As part of the deal, the UMC provides Adis with
newsletters from National Centres. Through the UMC/Adis partnership National Centres get
access to newsletter information and reviews of drug safety literature from 6,000 biomedical
journals. The UMC also contributes to Reactions Weekly with summary information from
VigiBase on drug adverse reactions referenced in Reactions Weekly that are published in literature
for the first time.
The 24-page Uppsala Reports newsletter is intended for all people concerned with issues of
pharmacovigilance. Uppsala Reports gives general information about developments within the
WHO Programme for International Drug Monitoring and other activities in which the UMC is
involved, generally not related to individual drug safety issues. A message from the Director
often stimulates lively debate. This publication is provided free of charge to recipients
worldwide and is also published in pdf format on the UMC website. Uppsala Reports was
published in July and October 2008 and January and April 2009. Major articles included full
reports on the Annual Meeting in Uppsala, the launch of VigiMine, introductions to the new
countries joining the WHO Programme and articles describing important changes to data
management systems at the UMC.

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5.3. Services provided via electronic media
The Centre operates an e-mail address list ‘Vigimed’ which allows e-mail messages to be sent to
one address for distribution to all members of the Vigimed list. Vigimed is used for rapid
distribution of drug safety alerts and general requests for information related to specific cases.
The Vigimed listserver had 337 members from 107 countries (plus UMC staff) by the end of the
period. During the year around 230 messages, a decrease of 25% from last year, were shared via
the Vigimed mailing list. Topics raised also created many direct exchanges between Vigimed
members not shared with the whole group. UMC is investigating new technical solutions for
supporting Vigimed communications, avoiding inconveniencies with the present platform.
The Centre has continued with regular updating of its internet web site (www.who-umc.org),
with considerable information about the WHO Drug Monitoring Programme, the Uppsala
Monitoring Centre and on-going activities. New features included video recordings of some
lectures made at the UMC pharmacovigilance training course. The Products and Services
department of UMC maintains a separate website to benefit customers of UMC’s commercial
products and services (www.umcproducts.com).
5.4. Ad hoc retrievals for National Centres
In addition to on-line searches made by National Centres, requests for ad hoc retrievals in the
database continue to reach the UMC. The investigations requested are often of such a
complexity that they cannot be managed using the on-line retrieval software. From July 2008 to
June 2009 the Centre performed 11 special database investigations for WHO, 25 investigations
for National Centres and three searches for reviewers and other non-paying customers.
5.5 Detection and analysis of adverse reaction signals
Potential signals resulting from review of reports in VigiBase are analysed by UMC staff and the
UMC Review Panel. The Review Panel consists of more than 40 clinical expert volunteers from
23 countries. Evaluations considered to be signals are presented in the SIGNAL document and
circulated to National Centres, Review Panel members and other individuals identified by
National Centres as legitimate recipients.
During the period, four issues of the SIGNAL document, containing 15 articles, were produced
and sent to approximately 230 recipients. To encourage a healthy debate, extracts from the
SIGNAL document were made available to international pharmaceutical companies who could
be identified as uniquely responsible for the concerned drugs. In total 8 responses were received
and published alongside the texts in the SIGNAL document.

6. Other collaboration with WHO Headquarters, Geneva

6.1 WHO Public Health Programmes
As of March 1st 2009 J. Labadie was employed as Vaccine Safety Specialist by UMC, with
financial support from WHO. Efforts were focused on the Global Network for Post marketing
Surveillance of Newly Pre-qualified Vaccines. The 11 countries from all 6 WHO-Regions in this
network will use VigiFlow to report Adverse Events Following Immunization (AEFI). For this
purpose VigiFlow was updated with an additional section to accommodate the reporting of
vaccine specific data (see section 10). VigiBase will serve as the AEFI database for the Network.
Preparations to adapt UMC’s Drug Dictionary to include relevant vaccine specific information
were started. This will facilitate and improve the quality of analysis of AEFIs from VigiBase. As
a consequence of the new initiative UMC was also represented at the meeting of the Global
Advisory Committee on Vaccine Safety (GACVS) in June, 2009.

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The WHO Global Malaria Programme and the WHO HIV/AIDS department are active in
extending access to effective drug therapies in disadvantaged areas. The active roll-out of
treatments using new medicines for previously untreated populations leads to a need to monitor
the safety of those new therapies. UMC is an active partner with the WHO HIV/AIDS and
malaria control programmes in developing methods for active surveillance and in building
capacity through pharmacovigilance training.
6.2 WHO Advisory Committee on Safety of Medicinal Products
The Quality Assurance and Safety of Medicines team at WHO, Geneva, has established an
Advisory Committee on Safety of Medicinal Products (ACSoMP). ACSoMP had its sixth
meeting in March 2009, with R. Edwards, S. Olsson and M. Lindquist representing the UMC.
Recommendations included guidelines for applications to the WHO Model List of Essential
Medicines, the need for a WHO global strategy for pharmacovigilance, and the need for set of
core indicators to guide pharmacovigilance centres and to measure their progress.

7. Support to development of National Centres and UMC visits

UMC staff members made site visits working with representatives of national
pharmacovigilance systems as follows:
• Botswana (R Edwards, M Lindquist, U Rydberg)
• Saudi Arabia (S Olsson)
• Tanzania (M Wallberg, S Pal)
• Uganda (S Olsson, H Wilmar)
• Singapore (A Bate)

8. Training in pharmacovigilance
A training course for 11 Western Pacific countries took place in Manila, The Philippines in
September 2008, with the UMC represented by a consultant.
ISoP training courses in Verona (March 2009) included input from the UMC.
A DIA meeting in Singapore in December heard a talk about the UMC’s data-mining work.
The UMC’s 12th biennial training course ‘Pharmacovigilance – the Study of Adverse Drug
Reactions’ took place from 25 May to 5 June 2009 with an international group of students from
30 countries.
The collaboration between the UMC and the Department of Toxicology, University of Uppsala,
in providing a five-week undergraduate course on drug safety and pharmacovigilance to
pharmacy students continued in November 2008 and again in February 2009.

9. Release of adverse reaction information to external inquirers

Since the WHO 10th International Conference of Drugs Regulatory Authorities (ICDRA)
meeting in Hong Kong, 2002 recommended: ‘Opening access to the WHO database to all
stakeholders with a genuine public health interest and ability to evaluate such case information’,
case information from all countries participating in the WHO Programme is released to any
inquirer fulfilling these criteria.
A considerable demand for database investigations is directed to the Centre from investigators
in industry, academia and consumer organizations. Centre staff responded to 109 requests for
database retrievals during the period. The inquirers were provided with the results together with
the agreed ‘Caveat Document’.

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10. Development of computer support systems
The production and development team of computer support systems continues to further
improve the production environment for all VigiBase operations; from the processing of
received ICSRs and entering of drug information into the database, to extraction of data into
the WHO Drug Dictionary Enhanced and VigiBase Export; but also to improve processes such
as for the signal detection by enhancement of the VigiMine module in VigiSearch.
In late 2008, VigiBase was migrated into a new database platform which facilitates the use and
performance of the database. The focus for the last year has also been on development of web-
based reporting tools based on similar techniques as VigiFlow: PaniFlow, for collecting adverse
events following vaccination with pandemic influenza vaccine, developed in close collaboration
with the Swiss drug regulatory authority, Swissmedic, and CemFlow, for collection of data in
Cohort Event Monitoring programmes. The PaniFlow tool will be used by Swissmedic in the
vaccination programme for the new influenza. The CemFlow tool will primarily be used to
support data collection in CEM programmes in African countries, supported by WHO.
In late June VigiFlow 4.1 was released; the biggest change was the new tool for searching for
drugs and terms. Vaccine specific fields have also been added to VigiFlow 4.1, primarily to be
used within the Global Network for Post Marketing Surveillance of Newly Pre-qualified
Vaccines (see 6.3). Other enhancement during the year was the pilot-release in April of a web-
based training course, VigiFlow e-learning.
Other achievements during the year were an improved WHO-DD Browser: new features such
as drug comparison functionality, data export, and request for new drugs through the browser
have been added to the WHO DD Browser 2.1, released in early June.

11. Terminologies
11.1 WHO Drug Dictionaries
The WHO Drug Dictionaries have over the past years become the de facto standard for coding
and analysis of concomitant medication in individual case safety reports and in clinical trials. In
both areas the Dictionaries help users in the life sciences to better understand how drugs may
interact – and this understanding leads to the safer use of drugs.
The Dictionary describes drugs from over 100 countries. The number of countries is increasing
as well as the coverage within each country. The focus for the UMC has been to increase the
coverage of conventional and traditional drugs in countries where many clinical trials are
conducted – such as China, India and Japan. Additional data is also collected to allow names to
be written with the characters used in these countries.
The use of the Dictionaries within the organisations is increasing and new tools such as
Standardized Drug Queries are being developed that will enhance the analysis of concomitant
medication. The new tools are being developed in collaboration with experts in the
pharmaceutical industry.
On 1 September 2009, the Dictionary contained:
• 199,943 unique names
• 1,517,736 different medicinal products, trade names with for example form and strength
information added
• 10,427 different ingredients mentioned in these products.

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11.2 Adverse Reaction Terminology
The WHO Adverse Reaction Terminology (WHO-ART) is maintained by the UMC and
developed in English. An update of the translation into French has been made and will be
implemented in WHO-ART after quality checks have been made.
WHO-ART is produced four times a year and sent by e-mail attachment to National Centres.
From 2008 files are not sent to ICH countries (as they are using MedDRA), or countries using
VigiFlow for reporting to UMC, other than by request. A new version of WHO-ART in English
was produced in paper printed version during the spring of 2009 and distributed to National
Centres.
MedDRA was introduced into VigiBase in March 2008, to be used alongside WHO-ART, after
a request from the MedDRA MSSO. A majority of ICSRs are sent to UMC using MedDRA and
searches in VigiBase can be made using MedDRA. Maintenance of WHO-ART has been kept at
a low level during the last year. All WHO-ART terms are mapped to MedDRA.
Since July 2008, 8 new terms have been included in the WHO-ART hierarchy, 3 of these being
preferred terms.
The WHO-ART – MedDRA bridge linking WHO-ART Preferred terms to MedDRA terms,
which was first released in March 2007, is updated annually and was distributed to all WHO-
ART customers with the March release of WHO-ART.
The list of critical terms, a concept that is unique to WHO-ART, was updated in the 2008
update of WHO-ART and is being maintained.
A number of companies and other institutions outside the WHO Programme continue to use
WHO-ART in their drug safety work.

12. Research and development

The Research department continues to further improve the UMC’s suite of analytical methods
for detecting emerging safety issues in VigiBase and other health-related data sets. An important
milestone was the publication of methods for temporal pattern discovery in longitudinal
electronic patient records developed by the UMC over the course of the past years. A
comprehensive evaluation of the advantages and disadvantages of routine stratification in signal
detection was published in Drug Safety. Among the important methodological developments in
VigiBase are the implementation and evaluation of measures of quality for individual case safety
reports, which will improve signal detection triages and detect systematic quality problems on
incoming reports, and the development of methods to extract structured information on
Adverse Drug Reactions from free text.
Several applied studies were published in medical journals during the year. For the first time
ever, a UMC signal on a suspected drug-drug interaction was accepted for external publication.
In addition, comprehensive review papers on signal detection and data mining were published in
Pharmacoepidemiology and Drug Safety and Drug Discovery Today. Oral and poster presentations were
given at various international meetings across Europe, Asia, and North America and continued
to raise awareness of the UMC’s leading work in analytical methods for pharmacovigilance.
In October 2008, the UMC hosted an international scientific meeting on ‘Impacting patient
safety: Adverse drug reaction signal detection’ with high-profile invited speakers from Europe
and elsewhere. The UMC participated actively in the development of the PROTECT public-
private partnership for improved methods for pharmacovigilance and pharmacoepidemiology,
which was selected for funding by the European Innovative Medicines Initiative. This
multinational collaboration involves various national authorities and pharmaceutical companies;
the UMC will co-lead the work-package on improving signal detection methods.

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13. Co-operation with other organizations
13.1 International Conference on Harmonization (ICH)
M5 – Data Elements and Standards for Drug Dictionaries/E2B - Data Elements for
Transmission of Individual Case Safety Reports: Following a decision in 2006 by the ICH
Steering Committee, a new cooperation is in place with the International Standardisation
Organisation (ISO) to develop ICH proposed standards into fully international ISO standards.
Currently ICH M5 (standards and data elements for drug dictionaries), and E2B (electronic
transfer of Individual Case Safety Reports (ICSRs)) have been referred to ISO for development,
including the definition of the technical formats for data exchange, and a maintenance process
for the resulting terminologies.
ICH participants are well represented in the ISO task force teams, and the activities relating to
M5 and E2B have been limited mainly to monitoring ISO progress.
13.2 European Union (EU) / European Medicines Evaluation Agency (EMEA)
The UMC has a good collaboration with EMEA in the area of scientific methodology for
identification and analysis of safety problems. In 2009, EU funding has been granted for an
Innovative Medicines Initiative (IMI) project, PROTECT, with EMEA as lead and UMC as one
of the partners.
However, the issue of improving ICSR reporting efficiency from European countries to the
UMC through a collaborative effort with EMEA is not resolved. Referring to lack of resources
and legal issues in relation to data protection, EMEA representatives have stated that a
collaborative solution cannot be implemented until after new EU pharmacovigilance legislation
is in place, at the earliest in 2010. The UMC has undertaken to make a survey of current
reporting practices among European countries, to EMEA and UMC, and how the countries
would like to improve the efficiency. Based on the results of this survey, new discussions with
EMEA will be held.
13.3 International Organization for Standardization (ISO)
The standardisation process which started in 2003 with UMC/WHO proposing to ICH that the
WHO Drug Dictionary should be used to facilitate coding of medicinal products for
international exchange of ICSRs (ADR reports) has since 2006 been taken over by ISO, on
request by ICH. Two ISO task forces have been set up specifically for the purpose of
developing new standards based on ICH draft guidelines; M5 and E2B(R). In the ISO forum,
the work items are referred to as Identification of Medicinal Products (IDMP) and Individual
Case Safety Reports (ICSR).
The scope of the standards has been modified; most importantly, the standards are now
restricted to “develop data elements, structures and relationships between the data elements
required to uniquely define and identify medicinal products”. This means that the content
deliverables (the controlled vocabularies*) are no longer incorporated in the standards, nor are
the maintenance requirements for the controlled vocabularies; the maintenance requirements
are now to be produced as a separate part of a Technical Report which is currently under
development by another ISO working group.
Albeit separated from the standards themselves, the issue of maintenance and the appointment
of a future maintenance organisation are still on the agenda. It is proposed that the separate part
of the Technical Report on maintenance will specify the implementation of this standard,
including development of content and a reference standard. It is currently not clear what the
“development of a reference standard” entails. From previous discussions however, the ICH

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group have expressed their firm view that one or more maintenance organisations must be
appointed as part of the process, and if this is not done within the ISO process, there is a high
probability that this will pursued by ICH as part of the work on implementation guidelines for
the ICH regions.
Thus, the risk remains to the WHO Drug Dictionary as the current de facto standard, and
therefore to the UMC and the WHO Programme.
* Controlled vocabulary: a computerised list/database including detailed data on medicinal products, formatted in a
structured way, and with unique identifying numbers/codes for each entry – the codes are intended to be used
when exchanging information, e.g. in ICSRs.

14. Meeting of representatives of National Centres

The 31st Annual Meeting of representatives of National Centres participating in the WHO
Programme was held in Uppsala, Sweden, from 20-23 October 2008. It was the largest
gathering of the Programme so far, with over 120 delegates from 55 countries present. WHO
Headquarters made a report of the meeting in early 2009. As well as reflecting on 40 years of the
global WHO Programme other themes of the meeting were:
• Looking forward to the next ten years
• Data-mining longitudinal patient records
• Safety in children
Two sets of workshops examined: Definitions, Indicators for impact of pharmacovigilance,
Vaccine crisis management, Safety of herbal medicines; and, Decisions on benefit and harm,
Promoting patient reporting, Better use of national databases, Strategies for medication errors.

15. Other presentations and meetings

Representatives of the WHO Collaborating Centre were invited to present research papers, the
activities of the WHO Drug Monitoring Programme and related subjects at various meetings
and conferences not mentioned in paragraphs 7 and 8:
• UMC staff took part in the annual ISPE conference in Copenhagen, in August 2008, and
also in the annual SIGKDD conference in Nevada.
• The UMC’s open meeting ‘Impact Patient Safety: Adverse Drug Reaction Signal Detection’
in October 2008 included presentations by UMC staff as well as from distinguished
international experts.
• The First International Symposium on Biopharmaceutical Statistics in Shanghai included
presentations about the UMC’s statistical work.
• The UMC took part in an Indian Medical Association conference in Hyderabad.
• UMC staff participated in the 8th ISoP Annual Meeting in Buenos Aires in October 2008
• Two UMC staff took part in a WHO Congress on Traditional Medicines in Beijing also in
November.
• The UMC were represented at an International Conference on Pharmacovigilance and
Clinical Data Management in Mumbai in November 2008.
• The Director participated in a WHO working group on traditional medicines in Hong Kong
in May 2009.
• AMFm meeting in Geneva, April 2009 included UMC representation.

16. Visitors to the UMC

• At the WHO Programme meeting the UMC welcomed Björn Håkansson of the Swedish
Thalidomide Society, David Finney, Professor Emeritus of Statistics at the University of

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 Edinburgh, Dr Ed Napke, founder director of the Canadian Drug Adverse Reaction
Reporting Program with his wife Gunvor, Barbro Westerholm, physician and Swedish
pharmacovigilance pioneer, and the Swedish journalist and writer Sigrid Kahle.
• Mirthe Pasmans, a student working with our collaborators in Utrecht visited in autumn
2008.
• Ruth Savage (New Zealand), a signal reviewer, and regular visitor, made two visits in 2009.
• In November 2008 three visitors from the School of Pharmacy, University of Addis Ababa:
Professor Teferi Gedif, Dean, Professor Kaleab Asres, Department of Pharmacognosy and
Professor Ephrem Engidawork, Department of Pharmacology came learn about
collaboration between the UMC and the new pharmacovigilance centre in Ethiopia and how
the School of Pharmacy may support the development of patient safety in the country.
• David Coulter from New Zealand visited in March 2009, providing expert advice for
terminology for Cohort Event Monitoring, and the CemFlow system being developed.
• Catrine Pansegrau Hauge, a 4th year pharmacy student at the University of Bergen, Norway
discussed aspects of her thesis on ADR reports on children in Norway.
• Richard Dart, Executive Director and Jody Green, Associate Research Director, of the
Rocky Mountain Poison and Drug Center (RMPDC), in Denver, Colorado, visited on 14th
May 2009.

16. Publications
Publications from the WHO Collaborating Centre 2008/2009
Pokladnikova J, Meyboom RHB, Vlcek J, Edwards IR. Intranasally administered corticosteroids and
neuropsychiatric disturbances: a review of the International Pharmacovigilance Programme of the World
Health Organization. Ann Allergy Asthma Immunol, 2008;101:67-73.
Lindquist M. VigiBase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal,
2008, 42:409-419.
Drug Benefits and Risks: International Textbook of Clinical Pharmacology, Edited by: Chris Van Boxtel, Budiono
Santoso and Ralph Edwards.
Edwards IR. Controlled Trials and Risk of Harm. Drug Safety 2008, 31(11), 961-963.
Hopstadius J, Norén GN, Bate A & Edwards IR. Impact of stratification on adverse drug reaction
surveillance. Drug Safety 2008, 31(11), 1035-48. With comments following by Stephen Evans and
response from the authors.
Norén GN, Bate A, Hopstadius J, Star K, Edwards IR. Temporal Pattern Discovery for Trends and
Transient Effects: Its Application to Patient Records. Proceedings of the Fourteenth International Conference on
Knowledge Discovery and Data Mining SIGKDD 2008, pages 963-971. Las Vegas NV, 2008.
Verdel BM, Souverein PC, Meyboom RHB, Kardaun SH, Leufkens HGM and Egberts ACG. Risk of
drug-induced photosensitivity: focus on spectroscopic and molecular characteristics. Pharmacoepidemiology
and Drug Safety (2009). Wiley InterScience (www.interscience.wiley.com) DOI: 10.1002/pds.1760.
Pokladnikova J, Meyboom RHB, Vlcek J, Edwards IR. Can intranasal corticosteroids cause migraine-like
headache? Cephalalgia. 2009; 29:360-364. (Epub 2008 Oct 22).
Derijks HJ, Meyboom RHB, Heerdink ER, de Koning GHP, Janknegt R, Lindquist M & Egberts ACG.
Associatie tussen antidepressivagebruik en glucosedisregulatie: bewijs op basis van bijwerkingenmelding
/ The association between antidepressant use and disturbances in glucose homeostasis: evidence from
spontaneous reports. PW Wetenschappelijk Platform 2009; 3(2):22-27.
Thesis
Sarah Fridén, Gender differences in international adverse drug reaction surveillance, Uppsala University,
Faculty of Pharmacy, June 2009.

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