Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model

How pharmacoepidemiology networks can manage distributed analyses to improve replicability and transparency and minimize bias

(2019) Robert W. Platt et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

(2019) Rosa Gini et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies

(2019) Ingrid S. Sketris et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Performance of a computable phenotype for identification of patients with diabetes within PCORnet: The Patient-Centered Clinical Research Network

(2019) Andrew D. Wiese et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Choosing Among Common Data Models for Real World Data Analyses Fit for Making Decisions about the Effectiveness of Medical Products

(2019) Sebastian Schneeweiss et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Danish health care system and epidemiological research: from health care contacts to database records

(2019) Morten Schmidt et al.   Clinical Epidemiology

Quantifying how small variations in design elements affect risk in an incident cohort study in claims

(2019) Rima Izem et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The use of real-world data in cancer drug development

(2018) E. Skovlund et al.   EUROPEAN JOURNAL OF CANCER

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

(2018) Xavier Kurz et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

OUP accepted manuscript

(2018)   JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION

Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study

(2018) Caitlin N. Dodd et al.   PLoS One

All-cause mortality and antipsychotic use among elderly persons with high baseline cardiovascular and cerebrovascular risk: a multi-center retrospective cohort study in Italy

(2018) Janet Sultana et al.   Expert Opinion on Drug Metabolism & Toxicology

Multidimensional Evidence Generation and FDA Regulatory Decision Making

(2017) Jonathan P. Jarow et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Increased risk for an atypical autism diagnosis following Thimerosal-containing vaccine exposure in the United States: A prospective longitudinal case-control study in the Vaccine Safety Datalink

(2017) David A. Geier et al.   JOURNAL OF TRACE ELEMENTS IN MEDICINE AND BIOLOGY

CodeMapper: semiautomatic coding of case definitions. A contribution from the ADVANCE project

(2017) Benedikt F.H. Becker et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology

(2017) Julien Bezin et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight

(2016) Pierre Engel et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

The FDA's sentinel initiative-A comprehensive approach to medical product surveillance

(2016) R Ball et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

21st century pharmacovigilance: efforts, roles, and responsibilities

(2016) Peter J Pitts et al.   LANCET ONCOLOGY

Multi-centre, multi-database studies with common protocols: lessons learnt from the IMI PROTECT project

(2016) Olaf H. Klungel et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The IMI PROTECT project: purpose, organizational structure, and procedures

(2016) Robert F. Reynolds et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Identifying Cases of Type 2 Diabetes in Heterogeneous Data Sources: Strategy from the EMIF Project

(2016) Giuseppe Roberto et al.   PLoS One

Finnish experiences of health monitoring: local, regional, and national data sources for policy evaluation

(2016) Katri Kilpeläinen et al.   Global Health Action

Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study

(2016) Andrea Arfè et al.   BMJ-British Medical Journal

Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study

(2016) Andrea Arfè et al.   BMJ-British Medical Journal

How Much Are Biosimilars Used in Clinical Practice? A Retrospective Italian Population-Based Study of Erythropoiesis-Stimulating Agents in the Years 2009–2013

(2015) Ylenia Ingrasciotta et al.   BIODRUGS

Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study

(2015) P. M. Coloma et al.   OSTEOPOROSIS INTERNATIONAL

Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design

(2015) K. Furu et al.   BMJ-British Medical Journal

Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design

(2015) K. Furu et al.   BMJ-British Medical Journal

Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?

(2014) G. Trifirò et al.   JOURNAL OF INTERNAL MEDICINE

Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee

(2014) Peter Arlett et al.   NATURE REVIEWS DRUG DISCOVERY

Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues?

(2013) Vera E Valkhoff et al.   BMC Pediatrics

The Nordic prescription databases as a resource for pharmacoepidemiological research-a literature review

(2013) B Wettermark et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Automating classification of free-text electronic health records for epidemiological studies

(2012) Martijn J. Schuemie et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project

(2010) Preciosa M. Coloma et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY