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:
Expediting access through Reliance Pathways: MENA region
Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.
Medical Device Registration in Russia. Challenges and Issues
Webinar: Medical Device Registration in Russia. Challenges and Issues The purpose of this webinar is to show the differences and specifics of regulations and law processes that can cause challenges in medical device registration in Russia. You will learn about:...
Drugs serialization and barcoding in Saudi Arabia and MENA region
An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...
