eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various regulatory strategies. Thus, the questions arises: how to choose the best tactics for eCTD submission that your needs?
The purpose of this webinar is to discuss the different approaches to prepare eCTD submissions, its requirements, technical resources, and process validation.
You will learn about:
1. Requirements for eCTD
- Different forms of eCTD used in EU vs. EAEU eCTD
- Legislation framework
- Regions and countries following the eCTD
2. Different approaches to prepare eCTD submissions: In-house vs. Outsourcing
- Advantages of eCTD submission outsourcing strategies vs. in-house management:
- Optimization of resources with proper experience
- Increased business continuity
- Cost optimization
3. Technical resources
- Software and networks
- Document and project management
- Potential challenges
4. How to validate submission to achieve compliance and high quality
- Tips and tricks
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Who Should Attend? Professionals from the following fields:
- Regulatory Managers
- Regulatory Strategy Managers
- RA Partnerships Operations Manager
- QA Managers supporting RA
- RA Healthcare Compliance Managers
Duration: 25 min.
Speaker: Head of Global Regulatory Affairs, Olga Bernardova, MSc, who will share her expertise regarding eCTD submissions.
Olga Bernardova, MSc
Head of Global Regulatory Affairs
