Recording: Update EU Pharma Legislation - The legal framework part 2

This recording delivers a clear overview of the changes to regulatory protection periods under the EU pharmaceutical reform. In approximately 90 minutes, you will understand the new Bolar exemption rule, launch conditionality, revised orphan drug rules, new incentives for antibiotic development and the new framework for repurposing known active substances.

• Changes to regulatory protection periods for medicinal products and orphan drugs (new Bolar exemption rule, launch conditionality, etc.)
• New incentives for antibiotic development (such as transferable exclusivity voucher)
• Repurposing - new rules for the reuse of known active substances

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 changes to regulatory protection periods and new incentive mechanisms under the EU pharmaceutical reform. In approximately 90 minutes, you will gain clarity on the new Bolar exemption rule, launch conditionality and revised orphan drug protection periods. The module also covers new incentives for antibiotic development, including the transferable exclusivity voucher, and the new rules for repurposing known active substances. By the end, you will be able to assess the impact of these changes on your portfolio planning and launch strategy.

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 protection periods and new incentive mechanisms
• Clear overview of changes to data and market protection for medicinal products and orphan drugs
• Guidance on the transferable exclusivity voucher and other incentives for antibiotic development
• Insights on the new repurposing rules for known active substances