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Card 6

Front

Who were the inventors of the ICH?

Back

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Card 7

Front

What are the key guidelines in the ICH new quality paradigm? (1)

Back

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Card 8

Front

What are the key guidelines in the ICH new quality paradigm? (2)

Back

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Card 9

Front

What are the aspects of quality - relevant guidance (ICH)

Back

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Card 10

Front

Describe features of a dossier (1)

Back

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Card 11

Front

Describe features of a dossier (2)

Back

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Card 12

Front

Outline the pathway for producing a biologic

Back

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Card 13

Front

What is the ICH Q8 guideline?

Back

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Card 14

Front

Describe features of ICH Q8 - pharmaceutical development (1)

Back

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Card 15

Front

Describe features of ICH Q8 - pharmaceutical development (2)

Back

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