Please also refer to ‘EMA pre-authorisation procedural advice for users of the centralised procedure ‘ Submission and assessment of information on user consultation. EMA/454165/2015 Overview of frequent issues in MAAs Page 5/7 . 1.3.6 . Braille.

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MAA pre-submission issues and EMA meeting opportunities Pre-submission meeting . Eligibility • Eligibility (mandatory or optional scope) to be requested / confirmed in ALL cases ! • 18 Months before planned submission or, at the latest 7 months - as part of ‘Letter of Intent’

The European Medicines Agency’s (EMA) is under investigation by European Ombudsman, Emily O’Reilly after she raised concerns that EMA’s pre-submission meetings with sponsors could influence the agency’s decisions about marketing authorisations (MAs). O’Reilly has begun the process of gathering evidence after writing to the Executive Director, Guido Rasi, at the EMA. In the letter, O ...

About EMA. In 1981, Emirates Medical Association (EMA) was established as a non-profit organization composed of health practitioners that are members of the EMA as defined by its bylaws. EMA is responsible for supervising and conducting scientific training, events and conferences as well as collaborating with health organizations.

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Information about Ma'ema'e's vision and mission statements. Ma'ema'e School is committed to building a future of unlimited possibilities for all students.