Is your Essential Requirements Checklist (ERC) up to snuff? 2015 covers topics such as:
- Define Essential Requirements and their relationship to Essential Requirements Checklist
- Background of the ERC and the proposed changes
- Sections in the ERC
- Format of an ERC
- Relationship between ERC, Clinical Evaluation Report, and Technical File
- What has changed in the 2012 proposal
Is your Essential Requirements Checklist (ERC) up to snuff? 2015 brings together:
- Regulatory/Quality Specialists who Compile European Technical Files
- Regulatory/Quality Managers or Project Managers
- Product Development Managers or Project Managers
- Clinical Personnel who Contribute to European Technical Files
