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The Excellence of ATESSIA’s CMC: Your Partner in Technical and Regulatory Affairs
In a constantly evolving pharmaceutical industrial environment, regulatory requirements for quality data are becoming increasingly complex. Health authorities are continually updating guidelines, increasing CMC demands
The Post-Approval Change Management Protocol or “PACMP”
In Europe, changes to a marketing authorisation (MA) for a human medicine are covered by Regulation (EC) No. 1234/2008 of November 24, 2008. This regulation
What are Good Manufacturing Practices (GMP) ?
Definition Good Manufacturing Practices are a set of principles and guidelines. The first GMPs were published in France in 1978. These guidelines are regularly updated
What are CEPs ?
CEP : what’s that? In Europe, three distinct possibilities exist for presenting information relating to the active substance, from a qualified manufacturer, used in a medicinal
What is the European Pharmacopeia ?
This article deals with the essential information you need to know about the European Pharmacopoeia (whose official acronym is “Ph. Eur.”), a unique reference work
What future for therapeutic cannabis in France?
A bit of history In September 2018, a multidisciplinary scientific committee made up of ANSM, healthcare professionals and patients was set up to review scientific
Poisonous Substances: What Use within the Pharmaceutical Industry?
Poisonous substances are defined in French legislation (and only in this legislation!) and include certain substances classified as dangerous according to categories defined by the
Therapeutic patient education versus learning programs: what is role for the pharmaceutical industry?
> Definition and content Therapeutic patient education (TPE) can be defined in several ways. The World Health Organization (WHO) gave the following definition in 1996:
What is the Requirement for Transparency of Conflicts of Interest with Healthcare Professionals in France?
Following the “Médiator” case and inspired by the Sunshine Act in the United States, the law of December 29, 2011, concerning the strengthening of health