As of May 5, 2018, INDs must be submitted using eCTD format.
This webinar will provide details on the entire process of submitting INDs in eCTD format including:
- Relevant regulations, guidance documents, formatting requirements, pdf specifications, eCTD technical requirements, IND content placement
- Process for transitioning to eCTD, roles and responsibilities, tools
- eCTD readiness, preparing PDF documents, quality checks, technical validation, attributes, STFs, ESG
After this webinar, participants should know:
- Where and how to find eCTD guidance and requirements on the FDA website
- What the process of transitioning from paper to eCTD entails
- Best practices, tools, and hints to help along the way
About the Speaker:
Adair Turner, MSc, RAC PharmaLex US,
Principal Consultant, Director Regulatory Operations
Adair Turner is responsible for electronic submission activities, regulatory information management and related topics. She has a wealth of experience in managing hundreds of Regulatory submissions throughout the product lifecycle, leading cross-functional project teams, and implementing innovative technologies.
Adair holds a BA from Rutgers University and an MSc from Arizona State University.