REMS- und RMP-Unterstützung

Ein REMS (Risk Evaluation and Mitigation Strategy) oder RMP (Risk Management Plan) ist ein von den Zulassungsbehörden vorgeschriebenes Risikomanagementprogramm, das darauf abzielt, arzneimittelbezogene Risiken gezielt zu erkennen, zu minimieren und zu überwachen.

Customer service professional in a contact center wearing headset asking a coworker-a-question

Diese Programme stellen sicher, dass Patient*innen Zugang zu notwendigen Arzneimitteln erhalten – bei gleichzeitiger Minimierung potenzieller Risiken. REMS (Risk Evaluation and Mitigation Strategies) bzw. RMP (Risk Management Plans) zielen darauf ab, ein spezifisches schwerwiegendes Risiko zu verhindern, zu überwachen und zu steuern. Dies geschieht durch gezielte Information, Schulung und die Förderung sicherheitsrelevanter Maßnahmen, um die Wahrscheinlichkeit und Schwere unerwünschter Ereignisse zu verringern. Solche Programme stärken das Bewusstsein für einen sicheren Umgang mit Arzneimitteln und vermitteln allen beteiligten Akteur*innen – insbesondere medizinischem Fachpersonal – wichtige Vorsichtsmaßnahmen. Die Contact Center-Services von ProPharma unterstützen REMS- und RMP-Programme, indem sie als zentrale Anlaufstelle für Patient*innen und medizinisches Fachpersonal fungieren. Unsere Dienstleistungen sind weltweit verfügbar – in über 40 Sprachen und angepasst an lokale Arbeitszeiten und Feiertage. Wir bieten skalierbare, flexible und individuell anpassbare Lösungen, um ein wachsendes REMS-Portfolio effizient zu begleiten. In enger Zusammenarbeit mit unseren Kund*innen teilen wir bewährte Verfahren, die Innovation und Effizienz gleichermaßen fördern. Unser Engagement für kontinuierliche Serviceverbesserung zeigt sich im Einsatz moderner Technologien – darunter Tools für Workforce-Management, digitale Kommunikationskanäle (z. B. Chatbots und Live-Chats) und Zufriedenheitsbefragungen. Darüber hinaus testen wir Telefonleitungen sowie z.B. Webformulare oder Emailkonten manuell oder automatisiert, je nach Anforderung.

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Kommunkation

Kommunkation

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Produktzugang und -information

Produktzugang und -information

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Management von unerwünschten Ereignissen (UE)

Management von unerwünschten Ereignissen (UE)

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Training und Edukation

Training und Edukation

Anfragen-Support

  • Weltweite Verfügbarkeit: ProPharma ist global tätig und bietet Unterstützung in allen unterstützten Sprachen – abgestimmt auf lokale Zeitzonen und regionale Gegebenheiten.
  • Multichannel-Kommunikation: Die Betreuung erfolgt über verschiedene Kanäle wie Telefon, Chat, E-Mail und weitere Kommunikationsplattformen.
  • Fachkundige Bearbeitung: Wir fördern eine informierte Entscheidungsfindung im Gesundheitswesen durch verlässliche Informationen und strukturierte Kommunikation.
  • Unterstützung fundierter Entscheidungen: Wir fördern eine informierte Entscheidungsfindung im Gesundheitswesen durch verlässliche Informationen und strukturierte Kommunikation.Facilitates informed decision-making for healthcare providers.
  • Zugängliche Wissensressourcen: ProPharma unterhält eine zentrale Sammlung von Antwortdokumenten sowie eine umfassende Datenbank aller eingereichten Anfragen.
  • Regelmäßige Berichterstattung: ProPharma stellt eine konsistente und detaillierte Berichterstattung sicher.
  • Compliance und kulturelle Sensibilität: Unsere Services entsprechen den jeweils geltenden gesetzlichen Vorgaben und berücksichtigen lokale und kulturelle Besonderheiten.
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Produktzugang und -information

  • Wichtige Informationen zum Produktzugang: Bereitstellung essenzieller Informationen, um den Zugang zu kritischen Produkten sicherzustellen.
  • Effiziente Verteilung: Optimierung der Verteilung von RMP-Materialien – sowohl elektronisch als auch in gedruckter Form.
  • Apotheken- und Programmsuche: Unterstützung bei der Suche nach Apotheken und Programmen, die den Zugang zu REMS-pflichtigen Arzneimitteln ermöglichen.
  • Patientenunterstützung: Unterstützung für Patient*innen, die mit finanziellen oder zugangsbezogenen Hürden konfrontiert sind.
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Management von unerwünschten Ereignissen (UE)

  • Erkennung und Aufnahme von unerwünschten Ereignissen: Unser erfahrenes Team identifiziert und erfasst unerwünschte Ereignisse effizient. Spezifische REMS-Fragebögen können bei der Aufnahme ausgefüllt werden.
  • Schnelle Reaktion: Sicherheitsbedenken werden zügig erkannt und umgehend an die Kund*innen weitergeleitet.
  • Präzise Triage: Gewährleistung einer genauen Triage und effektiven Kommunikation mit den zuständigen Teams.
  • Beschleunigte Berichterstattung: Einhaltung beschleunigter Meldefristen für unerwünschte Ereignisse.
  • Nachverfolgung nach dem UE: Gründliche Nachverfolgung nach unerwünschten Ereignissen – schriftlich oder telefonisch in der jeweiligen Landessprache.
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Training und Edukation

  • Bereitstellung von Schulungsmaterialien: Verteilung von Informationsmaterialien an Patient*innen, darunter Broschüren, Leitfäden und Warnkarten.
  • Aktuelle Informationen: Laufende Information für medizinisches Fachpersonal und Patient*nnen über aktuelle Strategien und Richtlinien im Risikomanagement.
  • Compliance-Reminder: Bereitstellung von Hinweisen und Informationen zu bewährten Verfahren, um die Einhaltung von Vorschriften sicherzustellen.
  • Zertifizierungsüberprüfung: Bewertung und Verifizierung der REMS- bzw. RMP-Zertifizierung von medizinischem Fachpersonal.
  • Unterstützung bei Schulungssitzungen: Begleitung bei Anmeldung und Nachverfolgung von Schulungsveranstaltungen.
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Our REMS and RMP Experts

  • Valerie Huh Bio Photo

    Valerie Huh

    Director, Global Innovation and Implementation

    View Bio

  • Ana Ming Bio Photo

    Ana Ming

    Senior Global Innovation and Implementation Manager

    View Bio

Valerie Huh brings over 20 years of experience in the pharmaceutical and healthcare industries, with expertise in global operations and process improvements. She holds a Doctor of Pharmacy (Pharm.D.), a degree in Chemistry, and an MBA with a certificate in business analytics. In her current role, she leads innovation and technology enablement in Medical Information and supports business expansions, driving forward strategic initiatives to enhance service quality and operational efficiency.

Ana Ming is a highly skilled pharmacist based in Australia, with 12+ years of experience in the pharmaceutical services and healthcare industries. Currently at ProPharma, she brings expertise in medical information management, patient care, and regulatory compliance. Additionally, Ana is a certified Justice of the Peace (JP), combining her healthcare experience with a commitment to community service and ethical leadership. Her collaborative approach, coupled with a focus on innovative solutions, makes her a valuable asset in optimizing patient outcomes and advancing pharmaceutical practices.

REMS- und RMP-Contact Center-Support

Sorgen Sie für einen sicheren Umgang mit Arzneimitteln und minimieren Sie Risiken mit den REMS-/RMP-Support-Services von ProPharma. Unsere weltweit zugänglichen Lösungen bieten fachkundige Unterstützung für Patient*innen und medizinisches Fachpersonal – in über 40 Sprachen. So stärken wir das Risikomanagement durch fundierte Entscheidungen und verlässliche Kommunikationskanäle.

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