NEW REGISTRATION OF MEDICINAL PRODUCTS IN COUNTRIES NOT BELONGING TO ICH REGIONS
The new registration of medicinal products in countries not belonging to ICH (International Conference on Harmonization) Regions is a challenging…
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THE LEGAL BASIS OF A MARKETING AUTHORIZATION APPLICATION AND THE PAEDIATRIC REGULATION
Even if for most of applications the definition of the legal basis appears to be quite obvious, the choice can…
READSPONSOR OF CONGRESSES AND MEETINGS: AIFA REQUIREMENTS
The Marketing Authorization Holder or the pharmaceutical company responsible for the commercialization of medicinal products in Italy, in order to…
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MEDICAL DEVICES: REGULATORY OBLIGATIONS IN ITALY
Medical devices are classified into four classes depending on their characteristics and safety profile (e.g. invasiveness , dependence on a…
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REGULATORY PHARMA NET MANAGING DIRECTOR, ANITA FALEZZA, INTERVIEWED @ TOPRA ANNUAL SYMPOSIUM 2015 – BERLIN
TOPRA’s Annual Symposia – covering pharmaceuticals, veterinary medicines and medical devices – are together the largest forum for European regulatory…
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READABILITY USER TESTING: THE DEADLINE FOR SUBMISSION FOR NATIONALLY AUTHORIZED PRODUCTS IS GETTING CLOSER
For all medicinal products registered in Italy via national procedure, the Marketing Authorization Holder is requested to submit within December…
READREGULATORY PHARMA NET EXHIBITS AT THE TOPRA ANNUAL SYMPOSIUM – BERLIN, GERMANY
From 12th till 14th of October RPN exhibits at the TOPRA Annual Symposium which will be held in Berlin at…
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EDUCATIONAL MATERIAL IN PILLS
Before the launch, any educational materials provided for in the Risk Management Plan of a centrally approved medicinal product shall…
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THE AUTHORISATION OF CLINICAL TRIALS ON MEDICINAL PRODUCTS IN ITALY
The conduct of Clinical Trials on medicinal products in Italy is subject to authorization by the Competent Authority (i.e. Agenzia…
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EARLY MARKET ACCESS OPTIONS
The granting of the community marketing authorisation (MA) does not mean a medicinal product is simultaneously available throughout all the…
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