This BASG seminar offers those interested a concise overview of the current requirements for Environmental Risk Assessment (ERA). We will also provide an outlook on possible future changes that may arise as a result of the new pharmaceutical legislation. The event will cover specific practical issues as well as examples of best practice.
Contents
- Legal basis (Directive 2001/83/EC) and scope
- Requirements of the ERA Guideline
- Decision trees for Phases I and II
- EPAR table and QRD template
- New pharmaceutical legislation
Generic medicines
- Current requirements + best practice
- Data sharing / Reference to published data
- Best-practice examples
Target audience
- Employees in the pharmaceutical industry
- Employees of consultancy firms in the pharmaceutical industry
Language
German
Registration information
Please register by 22 October 2026 at the latest.
This event will be held entirely online.
Technical Director
Mag. Dr Peter Platzer
Institute for Regulatory Affairs & Life Cycle Management, Medical Market Surveillance Division, AGES GmbH