Greetings!
Take the next step in NDS preparation.
NDS Level 2: Practical CTD and eCTD Preparation for Drug Product Submissions builds on foundational regulatory knowledge with a more advanced, practical look at preparing and managing drug submissions.
Participants will explore key areas including:
- Detailed preparation of CTD Modules 3, 4 and 5
- Quality, nonclinical and clinical study documentation
- Pre-submission meetings with Health Canada
- Responding to NODs, NONs and regulatory queries
- Managing the eCTD lifecycle and amendments
- Advanced cross-referencing, hyperlinking and filing practices
- Lessons from real-world NDS submission case studies
Designed for Regulatory Affairs, Quality, Clinical Research and pharmaceutical professionals looking to deepen their practical understanding of advanced drug submissions.
Register by September 1 to receive 20% off with Early Bird code SAVE20.
*All participants will receive a Certificate of Attendance upon completion. |
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