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The Agency has published an explanatory note to module VII of the guideline on good pharmacovigilance practices (GVP) providing additional clarification on the content of PSURs.

All MAHs should consult the explanatory note when preparing PSURs.

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This allows the single assessment of related PSURs to take place.

MAHs are required to submit PSURs according to the dates published in the EURD list.

Marketing authorisation holders (MAHs) must submit PSURs at defined time points following a medicine’s authorisation.

PSURs summarise data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorised uses and in unauthorised uses.

It addresses specific challenges in the EU for nationally authorised products, however, it highlights issues that may also apply to centrally authorised products.

The explanatory note will form the basis of the upcoming revision of module VII of the GVP guideline and both documents should be read in conjunction.The Agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed.It can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.Our goal with News Feed has always been to show people the things they want to see.When people see content that’s relevant to them, they’re more likely to be engaged with News Feed, including stories from businesses.For more information, see PSUR roadmap: joint industry/assessor training As of 13 June 2016, MAHs are required to submit all PSURs in the EU to the central PSUR repository, using the e Submission Gateway/ Web Client.

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