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ANSM partner of "Month without tobacco"

The "Month Without Tobacco" initiative is a public health campaign that is part of the National Tobacco Reduction Program (NRTEP 2014-2019). All the actions of the ANSM make it a recognized player in this program, in which it participates in the framework of the Cancer Plan.

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Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

Disclaimer:

This paper is about the use of 0, and is proposed for use in drug development and marketing authorization applications. It was also prepared to comment on the relationship between the two and the other. Whilst in some parts the paper describes Frequentists statistical methods, the field is also open to explore alternative approaches, eg following the Bayesian methodology.

The current document does not contain any explicit explanations. It rather tries to establish a framework and a common language to facilitate the dialogue between stakeholders.

The content of this discussion paper and its implications will be discussed at a European Medicines Agency's public work shop at the end of the 12-month public consultation phase. A longer than usual EMA via interaction with the Scientific Advice Working Group.

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New Guide for the Electronic Transmission of Individual Observations of Adverse Reactions (ICSRs)

The evolution of pharmacovigilance regulation at European level has led to significant changes in the electronic transmission of individual case safety reports (ICSRs) among the various actors in order to:

- rationalize the exchange of information,
- to ensure better monitoring of the safety of use of medicinal products,
- enrich the content of the exchanged data.

It is in this context that new features of EudraVigilance will be implemented by the EMA from 22 November 2017.

In this respect, a new guide for the electronic transmission of individual observations of adverse effects (ICSRs) is available on our website.

Information for pharmaceutical companies concerning the electronic transmission of individual pharmacovigilance observations

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Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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