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Informa
TBC in 2021

2-day course

Discover practical solutions for managing global regulatory requirements and new challenges

Course Overview

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
Impact of the eCTD

Clarifying the impact of the eCTD on the regulatory submission process

E-submission
E-submission

Understand how to prepare and submit an eCTD


Harmonisation
Harmonisation

Harmonised procedures in the EU

Key requirements
Key requirements

Regulatory requirements for 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
  • Compliance
  • Electronic Publishing/ Submissions
  • Global Project Management
  • IT/IS
  • EDMS

CPD Certified

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.