Recording: Update EU Pharma Legislation - The legal framework part 1

This recording delivers a clear overview of the current EU pharmaceutical legislative framework. In approximately 90 minutes, you will understand the status of the legislative process, the scope of the new Regulation and Directive, and how related legal acts such as the Variation Regulation and the Critical Medicines Act are affected.

• Current status of the legislative process at EU level
• Overview of the new Regulation (procedure 2023/0131/COD) and the new Directive (procedure 2023/0132/COD)
• Impact on other legal acts (Variation Regulation, Critical Medicines Act, etc.)
• ePI - current legal status & regulatory requirements

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 current EU pharmaceutical legislative framework. In approximately 90 minutes, you will gain clarity on the status of the legislative process, the scope of the new Regulation and Directive, and their impact on related legal acts such as the Variation Regulation and the Critical Medicines Act. The module also covers the current legal status and regulatory requirements of ePI. By the end, you will be able to place the key legislative changes in context and assess their relevance for your day-to-day regulatory work.

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 the EU legislative framework
• Clear overview of the new Regulation and Directive and their procedural scope
• Guidance on the impact on related legal acts such as the Variation Regulation and Critical Medicines Act
• Insights on the current legal status and regulatory requirements of ePI