Introduction and Best Practices about electronic submissions in eCTD format and EXTEDO eCTDmanager Basic Training Greece

Electronic Submissions are about to become mandatory in eCTD format in Greece - Are you ready?

There are many elements to think about when preparing for eCTD and missing any one of them will result in non-compliant and rejected submissions. With eCTD submissions becoming mandatory for all submissions within the Greek market, is your organization ready?

To prepare you for this transition Unisystems and EXTEDO are offering a regional eCTD workshop on 11th July 2017 followed by two days of eCTDmanager basic level training. The workshop will provide you with the regulatory and technical details you need to ensure a successful eCTD roll-out within your organization. 

Workshop: Introduction and Best Practices about electronic submissions in eCTD format

09:00-09.30: Registration

09.30-10.00: Current eCTD status in Greece and Case Study presentation

10.00-11-00: Introduction of eCTD

  • Differences between NeeS and eCTD
  • General structure of an eCTD
  • Recommendation for industries/ applicants
    • Hardware / software specification
    • IT knowledge, applicant competency etc.

     

11.00-11.30 Coffee break

11:30-13.00: Details of the eCTD-structure

  • Files and folders
  • Meta data
  • Bookmarks and Hyperlinks
  • XML-backbone, Envelope
  • Lifecycle Attributes Experience in EU in eCTD: how can several strengths and dosage forms be handled in one eCTD dossier (handling of specific sections)

13.00-14.00: Lunch break

14.00-15.30: eCTD Lifecycle Management

  • Submission Lifecycle, e.g. Variations, line Extensions
  • Document Lifecycle (add/replace/append documents)
  • Special formats: ASMF, DMF

15.30-16.00: Coffee break

16.00-17.00 eCTD Best Practice

  • Do & Don´t
  • The most common validation issues and how to solve them

17.00-17.30 Questions and answers

eCTDmanager Basic Level Training Course

To ensure you get the most out of your purchased solution, EXTEDO offers detailed training for each product within the EXTEDOsuite solution portfolio.
Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or on-site. They comprise of a mix of presentations (~40% of the overall training), practical exercises (~40% of the overall training) and workshops (~20% of the overall training).

For detailed information regarding the agenda of our eCTDmanager Basic Level Training course click here. 

Event Details and Registration

Workshop: Introduction and Best Practices about electronic submissions in eCTD format:

11 July 2017
09:30-17:30 h

Cost: 59 € per person

eCTDmanager Basic Level Training Course

12-13 July 2017
09:00-17:00 h 

Cost: 899 € per person for two days

Please bring your own laptop for the training. You can connect to the training server via a WiFi network (the trainer will bring the necessary equipment). There's no software installation required!
So the requirement for the laptops are very simple:

  • The used laptops/notebooks should be Windows systems, equipped with Win XP or higher, but no "Home" versions. Apple/MAC’s are not recommended, as they don’t support the right mouse button.
  • Minimum required display size: 15”, resolution 1280x720 or better
  • Laptops must allow access to a WiFi network  (the use of a Ethernet LAN needs to be clarified in advance!).
  • Users must have the permission to change the WiFi (to connect to the training WiFi) and execute “Microsoft Remote Desktop connection”.
  • Ideally each Laptop should have a separate mouse. According to our experience working with a mouse is more comfortable than with the build-in touchpad.
Venue: Athens, Greece

 

Registration: 

www.unisystems.gr/events/introduction-and-best-practices-about-electronic-submissions-ectd-format-and-extedo

 

 

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