The process of collating, developing, submitting, and managing a regulatory submission for approval is a complex project where masses of data must be collated and speed is critical. The electronic CTD (eCTD) has simplified the submission process speeding up your data through the approval process, saving you valuable resources and time. Although much simpler, the eCTD still handles large documents and must be led by professionals who are knowledgeable and competent to minimise delays.
Global regulatory agencies are committed to implementing the eCTD as standard so regulatory professionals must stay up-to-date with the latest regulations and trends. On completion of this 2-day course, you will understand how to organise applications in the correct electronic format and style ready for submission. You will also examine life cycle eCTD management to ensure you are capable of managing the submission post-approval.
What will you learn?
Impact of the eCTD
Gain clarification on the impact of the eCTD on the regulatory submission process
Understand how to prepare and submit an eCTD
Get to grips with harmonised procedures in the EU
Delve into the regulatory requirements for the product lifecycle
Who is this course for?
This course is targeted towards regulatory affairs professionals working in submissions procedures.
- Dossier Management
- Document Management
- Data Management
- Electronic Publishing/ Submissions
- Global Project Management
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.