REGULATORY AFFAIRS – FLEXIBILITY FOR COVID-19 TREATMENTS
A Q&A document has been made available by the European Commission to provide guidance to MAHs, including clarifications regarding the…
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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – PUBLICATION OF THE MDR APPLICATION POSTPONEMENT
Due to the COVID-19 emergency, the European Commission proposed to postpone by one year the date of application of the…
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PHARMACOVIGILANCE – ADVERSE REACTIONS REPORTING DURING THE COVID-19 PANDEMIC
During the current pandemic, the reporting of adverse events related to the widespread use of medicinal products (including off-label use)…
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REGULATORY AFFAIRS – COVID-19 RESTRICTIONS: WHAT TO KNOW ABOUT GMP/GDP ISSUES
Covid-19 pandemic has led to different restrictions that may also have an impact on some on-site Good Manufacturing Practices (GMP)…
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CLINICAL TRIALS – SIMPLIFIED PROCEDURES FOR CT AND OBSERVATIONAL STUDIES FOR COVID-19 TREATMENT
Following the Legislative Decree n.18 of 17/03/2020, AIFA has published a Circular indicating the simplified procedures for the data acquisition…
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MARKET ACCESS – EXPLANATORY NOTE ON COMPASSIONATE USE REGARDING TREATMENT OF COVID-19
Following the legislative decree n.18 of 17 March 2020, AIFA published an explanatory note on Compassionate Use regarding treatment of…
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REGULATORY AFFAIRS – RISK EVALUATION ON NITROSAMINES STEP 1 – EXTENDED TO 1 OCTOBER 2020
Due to the severe impact of COVID-19 pandemic, the European Medicines Regulatory Network has agreed to extend the deadline to…
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REGULATORY PROCEDURES – SOLUTION on eCTD PUBLISHING AND SUMBISSIONS
Under Covid-19 emergency your company can face several challenges due the mandatory lockdown in place, and you may need a…
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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – Class I transitional provisions under article 120 (3 and 4): Declaration of Conformity Requirements
With the II Corrigendum of the Regulation 2017/745, the transitional provisions of the Article 120 (point 3 and 4) of…
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MEDICAL DEVICES – EUROPEAN COMMISSION DISCUSSING ON POSTPONING MDR APPLICATION
The current COVID-19 pandemic is quickly changing everything all around the world and healthcare systems are experiencing an extreme pressure…
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