Experts
Dr. Anna Baudo, Keypharma / IT
Erika Rottey, M.Sc.Pharm, MPCA / BE
Dr. Gerhard Neurauter, IABG-LSS / DE
How will the participant benefit from this workshop?
A deep understanding of how and why the eCTD has
been introduced and the benefits of generating eCTDs.
Which requirements need to be met to submit an eCTD
in Belgium, Europe, and North America.
Practical exercises to create an eCTD submission and
hands-on experience to maintain variations based on the
eCTD.
Who should participate?
All Regulatory Affairs experts and assistants who are
involved in the assembly and compilation of regulatory
submissions.
Topics covered on day one:
09:30 – 10:30...The eCTD – terminology, status and advantages of its implementation in Europe
10:30 – 11:30...Submitting an eCTD in Belgium and elsewhere in Europe – lessons learnt
11:30 – 11:45...Coffee break
11:45 – 13:00...Initial creation of an eCTD-based submission
13:00 – 14:00...Lunch
14:00 – 15:30...Applying the document view, navigation and creation of an eCTD publication
15:30 – 15:45...Coffee break
15:45 – 17:00...Administration of eCTD submissions, lifecycle management, validation, export and review
17:00 – 17:30...Discussion
Chair
Dr. Axel F. Wenzel, Managing Director, P.SS.T / DE
Experts
Harv Martens, President, ING America / USA
Dr. Timothy Buxton, Head of PM, EMEA / UK
Michel Genot, Project Management, DG3 / BE
Erika Rottey, M.Sc.Pharm, MPCA / BE
Hans van Bruggen, Director, eCTDconsultancy / NL
Rahul Mistry, CEO, GlobalSubmit / USA
Shy Kumar, President, Datafarm / USA
Joe Zoric, Director Regulatory Affairs, CanReg / CA
Rik van Mol, IBM SCORE Solution Leader – EMEA / BE
Dr. Thomas Städter, Managing Consultant, IABG-LSS / DE
Dr. Jaroslava Paraskevová, Head of Documentation &
Information, MEDA GmbH & Co. KG / DE
Who should participate?
This conference will particularly benefit life sciences
professionals who work in regulatory affairs: directors,
heads and managers of regulatory affairs, as well as IT
managers focusing on optimising information
management systems in pharmaceutical and
biotechnology regulatory departments.
Topics covered on day two
eCTD - A Globally Harmonized Standard? |
Harv Martens |
 |
Status of the eCTD review in the EU |
Timothy Buxton |
|
Submitting an eCTD in the EU - lessons learnt |
Erika Rottey |
|
Lifecycle Management - Advantages, Constraints and Lessons learnt with regard to the eCTD
|
Hans van Bruggen |
|
The eCTD: A US overview and perspective |
Rahul Mistry |
|
Recycling an eCTD: The FDA, Health Canada and Beyond! |
Joe Zoric |
|
Beyond Enterprise Content Management: IBM Solution for Compliance in a Regulated Environment
|
Rik van Mol |
|
IMPD and STF - a solution for study management inside an eCTD |
Thomas Städter |
|
An Approach for the DMS - based eCTD Management at MEDA Pharma
|
Jaroslava Paraskevova |
|
eCTD approaches by small and medium sized companies |
Shy Kumar |
|
Chair
Tore Bergsteiner, Managing Director IABG-LSS / DE
Andreas Suchanek, Managing Director IABG-LSS / DE
Who should participate?
This user group meeting is addressed to current and
future users of the eSubmission Management System
eCTDmanager. RA experts who are involved in the
eCTDmanager-based compilation and publishing of
submissions will get an idea of future developments.
The user group meeting will influence the priorities for
future functionalities to be covered by the system.
Topics covered on day three:
New Developments:
.............Management of multiple submissions in parallel
.............Integration of PIM / SPL into eCTDmanager
.............Import of manually created eCTDs
Ask the Experts Session
Wish List
