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Samenvatting Supply Chain Verticals (YB1239)
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Met deze samenvatting slaag je voor het vak Samenvatting Supply Chain Verticals zonder maar 1 keer naar de les te gaan.
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Supply Chain VerticalsInhoud
Les 1 – Hoofdstuk 1 – Inleiding tot de pharma industrie ........................................................................ 3
Stappen in het goedkeuring proces van medicijnen ........................................................................... 3
Wetenschappelijk onderzoek .......................................................................................................... 3
Klinische ontwikkelfase ................................................................................................................... 4
Kost en tijd voor het ontwikkelen van een medicijn ........................................................................... 5
Les 2 – Innovatie van medicijnen ............................................................................................................ 6
Biologische geneesmiddelen ............................................................................................................... 6
Gentherapie......................................................................................................................................... 6
Celtherapie .......................................................................................................................................... 6
Generische geneesmiddelen ............................................................................................................... 6
Biosimilar geneesmiddel ..................................................................................................................... 6
Medische hulpmiddelen ...................................................................................................................... 7
Overheden en controle organismen ................................................................................................... 7
Pharma organisaties ............................................................................................................................ 7
Les 3 & 4 – H2 - End to end pharma supply chain ................................................................................... 8
Aankoop .............................................................................................................................................. 8
Productie ............................................................................................................................................. 8
Centrale opslag .................................................................................................................................... 9
Lokale opslag ....................................................................................................................................... 9
Distributie ............................................................................................................................................ 9
Patiënt ................................................................................................................................................. 9
Logistieke control tower.................................................................................................................... 10
Planning, resources en routines .................................................................................................... 10
Herziening en rapportage.............................................................................................................. 10
Prognoses ...................................................................................................................................... 10
Implementatie ............................................................................................................................... 10
Beslissingen ................................................................................................................................... 10
Resultaten...................................................................................................................................... 10
Les 5 – H3 – GDP richtlijnen .................................................................................................................. 11
Annex 21 ............................................................................................................................................ 11
GDP .................................................................................................................................................... 11
Hoofdstukken in de GDP ................................................................................................................... 11
1
, Hoofdstuk 1 — kwaliteitsbeheer ................................................................................................... 11
Hoofdstuk 2 — personeel .............................................................................................................. 11
Hoofdstuk 3 — bedrijfsruimten en uitrusting ............................................................................... 11
Hoofdstuk 4 – Documentatie ........................................................................................................ 12
Hoofdstuk 5 — activiteiten............................................................................................................ 12
Hoofdstuk 6 — klachten, retourzendingen, vermoedelijk vervalste geneesmiddelen en
terugroeping van geneesmiddelen ............................................................................................... 12
Hoofdstuk 7 — uitbestede activiteiten ......................................................................................... 13
Hoofdstuk 8 — zelfinspecties ........................................................................................................ 13
Hoofdstuk 9 — vervoer ................................................................................................................. 13
Hoofdstuk 10 — Specifieke bepalingen voor bemiddelaars ......................................................... 13
Gastspreker 1 – TEVA ............................................................................................................................ 14
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