About The Course
The process of developing & submitting a regulatory submission for approval is complex and require significant amount of data to be collated. As global regulatory agencies accelerate the implementation ICH eCTD format, regulatory affairs compliance, data and dossier management teams require up to date knowledge of the latest regulations and trends, as well as competencies in the process of writing and building documents.
This masterclass enables pharmaceutical companies to assess and address their readiness for eCTD across people, process and tools perspectives. Upon attending, you will understand how to apply to your ICH and regional requirements, QC & validation criteria to your eCTD; as well as how to organise applications in the correct electronic format and style ready for submission.
Key Learning Outcomes
- Latest development on regulatory agencies’ guidelines on eSubmissions and ICH eCTD formats
- eCTD submission reviews
- Applying ICH and regional requirements to your eCTD
- Quality control and validation criteria in eCTD
- Considerations for organisational implementation and eCTD readiness
- Preparing for your eSubmissions: Common pitfalls and how to avoid
- Developing effective eCTD lifecycle management
Live Online Learning
Stay Home. Skill Up!
The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.
To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.
Benefits of Live Online Learning
Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.
- Classroom Experience: Progress with fellow participants as you would in an on-site class
- Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
- Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
- Module-based approach to effectively manage your time and revisions
- Earn your Digital Certification and broadcast your achievements to your peers
- Onboarding: Available for all attendees
- Proven and secure training platform
Impact of the eCTD on the regulatory submission process
- Introduction – from CTD to eCTD, electronically from applicant to agency
- Key challenges in using eCTD
- eCTD validation and review process
- eCTD submission review for both agency and applicant
- Organising your eCTD – Options for structure and design
- Tracking the progress and success of eCTD around the world
- Reusability of eCTDs across regions
Preparing for eCTD
- Transforming documents into electronic dossier
- Creating eCTD
- Common pitfalls and how to avoid them
- Region-specific administrative information
- Best practice and ICH requiremets
- Module specific requirements
Harmonised procedures in the US/EU/Asia
- Overview of electronic submission across regions
- Evaluating the challenges towards technical harmonisation
- Agencies’ eSubmission roadmap
- Online submissions – through gateways and portals
Practical Exercise – Lifecycle management
- Effective eCTD lifecycle management
- eCTD lifecycle operators
- eCTD lifecycle challenges and management
Building & submitting eCTD
- Types of software tools required in submitting electronically
- eCTD creation and assembly
- Creating file/folder structure and assigning documents
- Hyperlinks and eCTD attributes
- Building the required XML backbone and regional XML
Regulatory requirements for product lifecycle
- Time management and project planning for eSubmissions
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.