Recording: Update EU Pharma Legislation - Environmental risk assessment (ERA)

This recording delivers a clear overview of the evolving ERA requirements under the EU pharmaceutical reform. In approximately 90 minutes, you will understand the current legal framework, the changes proposed in the new directive, how ERAs integrate into lifecycle management, and how to handle legacy compounds and other special cases.

• Current legal framework and regulatory requirements
• Why the current requirements are tightened
• Changes and unknowns in the proposed directive
• Integration of ERAs into lifecycle management
• Handling of legacy compounds (authorised before 2006)
• Special cases: Endocrine and persistent active substances
• The role of antimicrobial resistance (AMR)

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 evolving Environmental Risk Assessment requirements under the EU pharmaceutical reform. In approximately 90 minutes, you will gain clarity on the current legal framework, the rationale behind the tightening of existing requirements, and the key changes and remaining unknowns in the proposed directive. The module also addresses the integration of ERAs into lifecycle management, the handling of legacy compounds authorised before 2006, and special cases such as endocrine and persistent active substances. By the end, you will be able to assess the ERA-related obligations relevant to your portfolio and identify the steps needed to ensure compliance under the new framework.

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 ERA requirements under the EU pharmaceutical reform
• Clear overview of current requirements and the rationale behind their tightening
• Guidance on integrating ERAs into lifecycle management and handling legacy compounds
• Insights on special cases: endocrine and persistent active substances, and AMR
• Understanding of the new transparency requirements and public access to ERA data