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Drug Regulatory Affairs

This class was created by Brainscape user assumpta widak. Visit their profile to learn more about the creator.

By: assumpta widak
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Decks in this class (15)

First exercise
What did the fda did to prevent i...,
To what was the program chnage to,
What is the objective of the q su...
60  cards
Marketing Authoisation Application
What are medicines approve of,
What are some examples for qualit...,
How do the agencies decide if a m...
67  cards
Advanced Therapy Medicinal products
What are the charatericts of atmps,
What are atmps,
Waht ar the three main types
47  cards
Pharmacovigilance
What is pharmacovigilance,
Nowadays pv includes,
What is the purpose of pv
46  cards
Variation and Renewals
What is a variation,
Changes not requiring any prior a...,
Changes requiring prior approval
56  cards
CTD
Ctd,
Objectives and advantages of the ctd,
Advantges of the ectd
10  cards
Regulatory Strategy
Ema responsibility,
Ema responsibility,
What are the key responsibilities...
54  cards
Seconde Exercise
How are gene therapy medicinal pr...,
What doe gtmps contain,
What doesnt include to the gtmps
57  cards
Second Exercise (part 2)
Biologics are,
Biosimilar refers to,
What is an example of a small var...
49  cards
ODD
Orphan disease is,
Orphan medicinal product,
Commission regulation ec 847 2000
14  cards
Herbal Medicine
What are herbal medicinal product,
How are herbal drug prepered,
Give examples of herbal drugs
25  cards
Narcotic drugs
What are the three main elements ...,
What are the united nations bodies,
What is the purpose of the chedul...
53  cards
Exercise 4
What is the raid information syst...,
What are some examples of the rec...,
Why is the ras implemented
52  cards
Exercise 4 (part 2)
What is the post authorization sa...,
Aim of the pass,
When is the pass imposed
30  cards
Pricing and Reimbursement
Pricing of medicinal products how...,
What the main differencex between...,
What are the main objective for t...
59  cards

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Drug Regulatory Affairs

  • Class purpose General learning

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