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Tuesday, June 20, 2017
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Plants and Food Supplements:

Regulatory Overview 2017

Synadiet training on  29th June in Paris

 

 

 

L’objectif de cette formation est  de connaître et maîtriser les aspects réglementaires liés aux plantes et à leurs préparations dans les compléments alimentaires en 2017.

Amélie DENIS, responsable du pôle réglementaire de NUTRAVERIS débutera cette session avec un point sur la réglementation nationale et communautaire des compléments alimentaires à bases de plantes et préparation de plantes (listes existantes, allégations plantes):

  • Plantes utilisables dans les compléments alimentaires : textes et listes spécifiques à la France, autres listes nationales en Europe
  • Allégations plantes en attente utilisables sous conditions, discussions en cours au niveau européen

 

Amélie DENIS

Amélie DENIS est ingénieur agroalimentaire. Elle et son équipe conseillent nos clients sur les évolutions, les applications et les interprétations des textes réglementaires au sein des 28 Etats Membres de l’Union Européenne. Très opérationnelle, l’équipe analyse la conformité des compositions, règles d’étiquetages, communications et notifient avec succès dans toute l’Europe plus de 2000 compléments alimentaires, produits pour sportifs, denrées alimentaires pour fins médicales spéciales, aliments enrichis, produits de nutrition infantile.

 

 

L’inscription à cette formation, dont la date limite est Jeudi 22 juin inclus s’effectue en ligne en cliquant ici
Informations pratiques :
Date et horaires : mardi 29 juin 2017 de 9h à 17h
Lieu : Club Foch – 39, avenue Foch – 94300 VINCENNES
Accès : Château de Vincennes (ligne 1) ou Vincennes (RER A)
 

NOL, Nutraveris Online, the most efficient data solution to create, keep up-to-date and launch your products in the 28 EU member states, used for 10years by more than 500 industry leaders informs you:

The aim of this 6-week, double-blind, randomized clinical trial was to compare safety and efficacy of saffron and fluoxetine in treatment of mild to moderate postpartum depression in women aged 18-45 years with mild to moderate postpartum depression. Participants received either a capsule of saffron (15mg capsule) or fluoxetine (20 mg capsule) twice daily for 6 weeks.

 

postpartum depression

 

There was no significant effect for time×treatment interaction on HDRS score [F (4.90, 292.50) = 1.04, p=0.37] between the 2 groups. 13 (40.60%) patients in the saffron group experienced complete response (≥50% reduction in HDRS score) compared with 16 (50%) in the fluoxetine group and the difference between the 2 groups was not significant in this regard (p=0.61). Frequency of adverse events was not significantly different between the treatment groups.

 

The results of this study may suggest that saffron is a safe alternative medication for improving depressive symptoms of postpartum depression.

 

 

Kashani L, Eslatmanesh S, Saedi N, Niroomand N, Ebrahimi M, Hosseinian M, Foroughifar T, Salimi S, Akhondzadeh S. Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial. Pharmacopsychiatry. 2017 Mar;50(2):64-68.

 

This information has been sourced bNOL, a collaborative and complete tool which contains all Regulatory, Scientific and Marketing data

  • It solves all regulatory issues since it contains the required information on all ingredients authorized in the 28 European member states…on regulatory status, health claims, authority opinions
  • It protects your investments since it is updated in real time with reliable quality information analyzed and reviewed by our experts, available hotline.
  • It enables you to be the most responsive with monthly reports and live alerts and a personal use of the information with a report editing tool and customizable bookmarks.

With NOL let’s : 

  • Formulate new innovative products
  • Check if your already existing formulas are still compliant with the in force regulations
  • Adapt your existing formulas to the requirements of other European countries where you are willing to export them
  • Do scientific & regulatory & marketing monitoring which enable to anticipate the withdrawal of products, the safety issues, new interesting scientific studies, the arrival of new players on the market…

 

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

contact@nutraveris.com, +33 2 96 76 54 87