Building the eCTD

Filing submissions is a time consuming, laborious task for industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the submission process. Using the eCTD has been proven to speed your data through the approval process, saving you valuable resources and time.

Your regulatory agencies are committed to implemeting the eCTD as standard. Attend this practical 2-day course and ensure you are submitting your applications in the correct electronic format and style from the onset.

NEW FOR 2012- Optional 1 Day Project Management Workshop

21st May 2012 & 18th September 2012

• Plan, organise and submit successful eCTDs
• Gain practical insight into how the Regulators review eSubmissions
• Build an eCTD from scratch
• Track and manage multiple agency submissions
• Implement time-saving strategies for streamlining eSubmissions

NEW FOR 2012- Optional 1 Day Project Management Workshop

21st May 2012 & 18th September 2012

For those attending this two-day course there is also the option of attending an additional interactive workshop:

Project management soft skills:

Gain critical knowledge on factors which will contribute to successful projects and what you need to avoid.

The workshop will cover:

• Leadership, Motivation and Stakeholder Engagement
• Stakeholder Analysis and Management
• Negotiation skills
• Conflict resolution
• Communication