Podcast
Questions and Answers
What does EMA stand for in the given context?
What does EMA stand for in the given context?
Which stage of the product lifecycle does the post-authorisation guidance from EMA pertain to?
Which stage of the product lifecycle does the post-authorisation guidance from EMA pertain to?
What is ISO IDMP standards related to in the post-authorisation stage?
What is ISO IDMP standards related to in the post-authorisation stage?
Which process involves changing the name of a centrally authorised medicine?
Which process involves changing the name of a centrally authorised medicine?
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What do Article 61(3) notifications involve in the post-authorisation stage?
What do Article 61(3) notifications involve in the post-authorisation stage?
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Which area does the guidance on interacting with EMA relate to?
Which area does the guidance on interacting with EMA relate to?
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What is the purpose of post-authorisation efficacy studies according to EMA's guidance?
What is the purpose of post-authorisation efficacy studies according to EMA's guidance?
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What does pharmacovigilance primarily address in the post-authorisation stage?
What does pharmacovigilance primarily address in the post-authorisation stage?
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What area does post-authorisation measures guidance from EMA cover?
What area does post-authorisation measures guidance from EMA cover?
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What does transparency primarily emphasize in EMA's post-authorisation guidance?
What does transparency primarily emphasize in EMA's post-authorisation guidance?
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