Webinar: eCTD Submission Different Strategies: In-house vs. Outsourcing
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
Registering a new product?
Make use of our experts to enter new markets. Explore your options in an informal chat with one of our experts.
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
Other content that might interest you:
Must-Know Legislation for Medical Device Registration in the EAEU
EAEU legislation for Medical Device registration has been continuously updating for the last six years since the Eurasian Economic Union, otherwise known as EAEU, was entered into force in 2015. Five countries have signed the "Treaty on the Eurasian Economic Union" to...
Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)
How do you realize Medical Device Registration in the Eurasian Economic Union (EAEU)? Learn about EAEU Conformity Assessment Routes and MRP.
Affiliate Based Outsourcing for Regulatory Affairs
Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.
