4.6 Article

Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders

Related references

Note: Only part of the references are listed.
Article Public, Environmental & Occupational Health

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry

Alexandra Simbrich et al.

Summary: This article discusses the challenges and opportunities in studying the long-term rare side effects of multiple sclerosis treatment, with a focus on the example of the German REGIMS registry.

DRUG SAFETY (2021)

Review Pharmacology & Pharmacy

Orphan drugs: major development challenges at the clinical stage

Diogo A. Fonseca et al.

DRUG DISCOVERY TODAY (2019)

Article Pharmacology & Pharmacy

Key Learning Outcomes for Clinical Pharmacology and Therapeutics Education in Europe: A Modified Delphi Study

David J. Brinkman et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2018)

Article Pharmacology & Pharmacy

Drug Registries and Approval of Drugs: Promises, Placebo, or a Real Success?

Carla J. Jonker et al.

CLINICAL THERAPEUTICS (2018)

Article Public, Environmental & Occupational Health

Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators

Alexandra Pacurariu et al.

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2018)

Review Environmental Sciences

Recommendations for Improving the Quality of Rare Disease Registries

Yllka Kodra et al.

INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH (2018)

Article Public, Environmental & Occupational Health

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013

Jacoline C. Bouvy et al.

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2017)

Review Pharmacology & Pharmacy

The impact of clinical trial monitoring approaches on data integrity and cost-a review of current literature

Rasmus Olsen et al.

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2016)

Article Pharmacology & Pharmacy

Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials

Jeppe Ragnar Andersen et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2015)

Article Genetics & Heredity

The European Cystic Fibrosis Society Patient Registry: valuable lessons learned on how to sustain a disease registry

Laura Viviani et al.

ORPHANET JOURNAL OF RARE DISEASES (2014)