This joint webinar, organised in partnership between the EMA and the industry, aims to provide a platform for discussion and awareness on current and future EMA post-authorization framework, including variations and renewals. This event builds up on last year's session: "Regulatory Reliance Tools Unveiled – A Practical Guide by EMA."

This year, we will further explore how EMA assessment outputs can support regulatory reliance pathways, helping to streamline the approval of variations (CMC, clinical/safety) efficiently and sustainably.

Spearheaded by EMA, with the participation of WHO and global regulators, the webinar will:

• Explain EMA’s variations and renewals process.
• Describe the purpose and content of assessment document outputs and their relevance for regulatory reliance.
• Address participant questions to enhance understanding and application of these tools.

Target audience

Regulators and industry representatives from Asia, Africa, the Caribbean, Latin America, and the Middle East.

Format

Presentations followed by a Q&A session between regulators and the audience.

A limited set of pre-prepared questions for the panel will allow more time for audience participation.

The webinar will be conducted in English, with translations provided in French, Portuguese, and Spanish.

Practical information

• Date: 3 April 2025
• Time: 13:30-15:00 (Central European Time)
• Where: Zoom webinar

Registration

Registration is free but mandatory to attend the webinar.