Search results with tag "Rare diseases"
6.19 Rare diseases - World Health Organization
www.who.int6. Priority diseases and reasons for inclusion 1 6.19 Rare diseases See Background Paper 6.19 (BP6_19Rare.pdf) Background In the EU, a disease is considered to be rare when the number …
Epidemiologic Study Designs - Hopkins Medicine
www.hopkinsmedicine.org–Impractical for rare diseases and diseases with a long latency –Expensive •Often large study populations •Time of follow-up –Biases •Design - sampling, ascertainment and observer •Study population – non-response, migration and loss-to-follow-up
Orphan medicinial product designation
www.ema.europa.euThe European Medicines Agency, through its Committee for Orphan Medicinal Products (COMP), is responsible for reviewing designation applications from persons or companies ('sponsors') who intend to develop medicines for rare diseases, known as 'orphan medicines'. The Agency helps sponsors to prepare orphan-designation applications through free pre-
Confidentiality - NHS Code of Practice - GOV.UK
assets.publishing.service.gov.ukFor example, rare diseases, drug treatments or statistical analyses which have very small numbers within a small population may allow individuals to be identified. This is information which does not identify an individual directly, and which cannot reasonably be used to determine identity. Anonymisation
Rare diseases, orphan medicines - European Medicines …
www.ema.europa.euRare diseases, orphan medicines . Getting the facts straight . EMA is eager for European citizens with rare diseases to have accessto specific and effective medicines. The European Union’s orphan legislation has been designedto help overcome the extra hurdles these medicines face to get on the market.
Rare diseases, orphan medicines - ema.europa.eu
www.ema.europa.euRare diseases, orphan medicines EMA/551338/2017 Page 2/4 2. Does orphan designation speed up development time and marketing authorisation?