Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Dr Fatima Bicane
Pharma Deutschland e.V.
All times mentioned are CEST.
Zielsetzung
This Live Online Training aims to provide a comprehensive understanding of the regulatory framework governing drug shortages in the European Union (EU) and explore strategies for compliance with EU regulatory requirements. It will discuss solutions for managing and mitigating drug shortages effectively and offer insights from experts on navigating current and future challenges.
Hintergrund
Drug shortages have become a critical issue in the European healthcare sector, with a significant impact on patient care, treatment continuity and pharmaceutical supply chains. The causes of drug shortages are diverse and can be due to manufacturing disruptions, raw material supply constraints, increased demand and regulatory compliance issues. These shortages can lead to treatment delays, increased costs and potential risks to patient safety.
To address this challenge, regulatory authorities such as the European Medicines Agency (EMA) and national competent authorities have implemented a number of guidelines and requirements to ensure the continuity of medicines supply. The European Shortage Monitoring Platform (ESMP) became fully operational on 29th January 2025. All marketing authorization holders are now required to use only this platform to report data on shortages and availability of medicines. Measures include notification of shortages, preparation of a Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP), registration of an industry single point of contact (i-SPOC) and increased transparency in the pharmaceutical supply chain. However, despite these efforts, ensuring compliance remains a major challenge for pharmaceutical manufacturers, wholesalers and healthcare providers who must navigate complex regulations while maintaining business sustainability.
This course will cover key regulatory requirements, recent legislative developments and practical approaches to compliance. It will also examine how industry stakeholders can effectively manage and prevent shortages while minimizing the impact on healthcare systems and patient welfare.
Zielgruppe
This course it intended for all person from EU with the following background:
- Regulatory Affairs Professionals
- Quality Assurance Managers
- Supply Chain and Procurement Specialists
- Pharmaceutical Manufacturers and Wholesalers
- Healthcare Providers and Hospital Pharmacists
- Legal and Compliance Experts in the Pharmaceutical Industry
Date & Technical Requirements
Date
Thursday, 30th June 2025, 13.00 h - 16.00 h
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department.
WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Understanding the EU Regulatory Framework on Drug Shortages
- The European regulatory strategy to manage and monitor drug shortages: current challenges and recommendations.
- Legal obligations for Marketing Authorization Holders (MAHs) and manufacturers
- Notification requirements and reporting obligations
Solutions for Managing Drug Shortages and Ensuring Compliance
- Collaboration with regulatory authorities, healthcare providers and stakeholders
- Implementation of a drug shortage prevention plan
- Causes of drug shortages and solutions
| ECA-Member*: | € 590,- |
| Non ECA Member*: | € 690,- |
| EU/GMP Inspectorates*: | € 345,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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