Recording: Update EU Pharma Legislation - Supply shortages and supply security

This recording delivers a clear overview of the new supply shortage obligations under the EU pharma reform. In approximately 90 minutes, you will understand the new prevention and risk planning requirements, the coordination between EMA and national competent authorities, and the practical implications for manufacturers and marketing authorisation holders.

• New obligations for shortage prevention and risk planning
• Coordination between the EMA, national competent authorities (NCAs), and pharmaceutical companies
• Reporting and monitoring obligations, EU mechanisms for shortage analysis
• Practical implications for manufacturers, marketing authorisation holders, and supply chain management
• Interplay with the Critical Medicines Act

This course is designed for regulatory affairs professionals with a solid background in EU marketing authorisation procedures. Legal/compliance, quality, pharmacovigilance and related professionals involved in planning and implementing EU regulatory requirements will also benefit from this recording.

This recording of a live webcast series provides a structured, practice-oriented update on the EU pharmaceutical reform. The webcast consists of four individual modules, each approximately 90 minutes long, which are available separately or as a complete bundle at a reduced price. This course covers one module. The bundle "Update EU Pharma Legislation - The Full Series" can be found via the webcode 60012660.

The recording of this module provides a structured overview of the new supply shortage obligations under the EU pharmaceutical reform. In approximately 90 minutes, you will gain clarity on the new requirements for shortage prevention and risk planning, the coordination mechanisms between EMA, national competent authorities and pharmaceutical companies, and the reporting and monitoring obligations introduced by the reform. The module also addresses the practical implications for manufacturers, marketing authorisation holders and supply chain management, as well as the interplay with the Critical Medicines Act. By the end, you will be able to assess the operational impact of the new shortage framework on your organisation and identify the measures needed to ensure compliance.

The recorded content is available to you flexibly - ideal for reviewing the topics at your own pace or looking up specific sections as needed. Access to the recording is available for 90 days after purchase.

• Recording of a live webcast - for maximum flexibility and self-paced learning
• Concise 90-minute format covering supply shortage obligations and supply security
• Clear overview of new prevention and risk planning requirements
• Guidance on reporting and monitoring obligations
• Insights on the practical implications for manufacturers and MAHs
• Understanding of the interplay with the Critical Medicines Act