Votre espace pharmacovigilance
QU’EST-CE QUE LA PHARMACOVIGILANCE?
La pharmacovigilance est la surveillance, l’évaluation, la prévention, la gestion du risque d’effet indésirable résultant de la prise des médicaments et des produits de santé quelques soient les conditions d’utilisations, conformes ou non conformes aux termes de l’AMM et les situations de surdosage, de mésusage, d’abus et d’erreurs médicamenteuses.
Questions et Réponses à vos préoccupations
QU’EST-CE QUE LA PHARMACOVIGILANCE?
POURQUOI SIGNALER UN CAS DE PHARMACOVIGILANCE ?
. Pour évaluer la balance bénéfices / risques des produits et affiner le profil de tolérance du produit,
. Pour une meilleure surveillance du produit et être conforme aux exigences réglementaires,
. Pour répondre aux exigences légales qui nous obligent à déclarer tous les effets indésirables (graves ou non) et les situations spéciales,
. Pour favoriser le bon usage du médicament
. Pour augmenter la connaissance d’un médicament (essais cliniques, phase de commercialisation),
. Pour minimiser les couts en matière de santé publique.
QUAND ET A QUI SIGNALER UN CAS DE PV ?
Quand ?
- Le plus rapidement possible
- Dans les 24h après la réception du cas : quelque soit la source de réception du cas PV, remonter l’information immédiatement
A qui ?
sendra.anonk@pharmainnov.com : Pharmacien Responsable PV
davila.kouame@pharmainnov.com : Pharmacien Adjoint au Responsable PV
pvmailbox@pharmainnov.com
– Attention à toujours bien renseigner l’objet du mail :
« cas de PV » – « Produit »
Si vous ne recevez pas d’accusé de réception dans les 24h merci de bien vouloir renvoyer un mail de relance
Les données importantes à recueillir pour déclarer un cas de PV sont :
– Le Notificateur (Professionnel de Santé qui rapporte le cas) : Nom et coordonnées
– Patient/Consommateur ANONYMISE : Initiales, âge ou groupe d’âge ou date de naissance, sexe
– Produit (s) suspecté(s) : Nom, dosage, numéro de lot, date de péremption
– Effet indésirable/Situation spéciale + Critères de Gravité
À partir du moment où vous avez
– un produit
DECLARER !!!
– un effet indésirable / situation spéciale
Fournir toute autre information nécessaire à l’analyse du cas :
– Coordonnées du Professionnel de Santé
– Durée du traitement
– évolution / gravité de l’effet indésirable
Il est important d’utiliser une fiche PV pour rapporter un cas de PV dans la mesure du possible.
Evaluer le cas PV et informer les autorités de santé.
General Questions
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How do I purchase your product?
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What is the Cancelation Period?
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Shipping Options Page Settings
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Setting up Product Attributes
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Downloadable Product
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What’s The Difference Between Annual & Monthly Billing
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How Do I Contact Legal?
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Where Are Your Offices Located?
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Finance Questions
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Can upgrade to premium package?
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What Happens If The Price Increases?
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Manage payment settings and invoices
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Pricing and plans guide
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Setting your company office hours
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Information Technology Questions
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Manage payment settings and invoices
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What Are The API Limits?
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Pricing and plans guide
It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.
Setting your company office hours
It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.