19 June - 12:00 - 13:00 BST / 13:00 – 14:00 CET
Impact of the Updated pERA Guidance and Upcoming Changes to the EU Pharmaceuticals Legislation  

As regulatory bodies place increasing emphasis on environmental sustainability in healthcare, understanding the evolving regulatory requirements around environmental risk is essential for compliance and responsible product stewardship.

This session will cover the revised pERA requirements and how they affect environmental data submissions, as well as the wider legislative reforms designed to improve access, innovation, and environmental protection within the market. In addition, experts will highlight how environmental fate (eFate) and ecotoxicology services can support robust, compliant environmental risk assessments, critical to navigating the new regulatory landscape.

Target Audience:

This webinar is designed for professionals working across the Pharmaceutical and veterinary medicine, and Biotech sectors who are involved in regulatory affairs, environmental compliance, and product development. Relevant roles including:
Regulatory Affairs Specialists and Managers, Policy Experts, Environmental Risk Assessors and Compliance Officers, Clinical Development Teams, Ecotoxicologists and Environmental Scientists, Sustainability and Corporate Responsibility Leads, Legal Advisors, Consultants and CROs supporting EU regulatory submissions.

Learning outcomes: 
• Understand the scope and requirements of the updated Pharmaceutical Environmental Risk Assessment (pERA) guidance and how it applies to human and veterinary medicinal products.
• Identify the key changes in the EU pharmaceutical legislation and evaluate how they may impact regulatory strategy, environmental compliance, and product development timelines.
• Integrate pERA considerations effectively into the early stages of product development.
• Recognise the role of environmental fate (eFate) and ecotoxicology studies in supporting robust pERA submissions.
• Develop action plans to prepare for upcoming regulatory changes and align internal processes with evolving EU environmental and pharmaceutical policy objectives.

Speaker details: 

• Glyn Horner, Head of Growth (CCSS), Fera Science Ltd. (Host)
• Richard Murray-Smith, Consultant - Environmental Risk Assessment, RSA 
• Victoria Pratt, Deputy Head of Environmental Fate and Metabolism, Fera Science Ltd.
• Karen Thorpe, Senior Aquatic Ecotoxicologist, Fera Science Ltd.

This webinar is sponsored by FERA

Disclaimer: Whilst TOPRA is running this webinar for FERA, this is not an endorsement of FERA, FERA's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

• Members: free
• Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.