WS 1

A practical introduction into PIM

Speaker: Mr. Farzad Shabestari and Mr. Shei Dattner, EXTEDO – IABG-LSS, DE

....Mr. Matthias Heyn, SDL International, BE

WS 2

Building eCTDs – a practical Workshop

Speaker: Hugues Trapp, Datafarm Inc., UK

WS 3

Integrating Document and Submission Management into one seamless

lifecycle

Speaker: Mr. Ken Hayward, QUMAS, USA

WS 4

Validation and viewing of eCTDs via EURS is Yours

Speaker: Dr. Gerhard Neurauter and Mr. Schei Dattner, EXTEDO – IABG-LSS, DE

WS 5

Planning and implementing electronic Document Management Systems

(eDMS) in regulatory environments

Speaker: Mr. Andreas Treptow and Mr. Stephan Grande, OPTIMAL SYSTEMS

GmbH, DE

WS 6

Preparing Compliant eCTD Submissions

Speaker: Antoinette Azevedo, e-SubmissionsSolutions.com, USA

09:00 –

09:05

Welcome

(Mr. Tore Bergsteiner, EXTEDO – IABG-LSS GmbH, DE)

09:05 –

09:10

Welcome and Introduction

(Mr. Hans van Bruggen, eCTDconsultancy, UK) – Chair

09:10 –

09:30

Welcome and “The eCTD in Hungary”

(Prof. Tamás L. Paál, OGYI, HU)

09:30 –

10:00

eCTD – Its all about planning...

(Mr. Shy Kumar, Datafarm Inc., USA)

10:00 –

10:30

Practical experiences with eCTD from the point of view of an R.a.D.

manager

(Dr. Tamás Szüts, ELECDOC, HU)

10:30 –

11:00

eCTD Validation at the agencies in the US, EU and Canada

(Mr. Harv Martens, ING America Inc., USA)

11:00 –

11:30

coffee and tea break

11:30 –

12:00

Compilation of a DCP dossier at MEDA Pharma GmbH & Co. KG

– exemplified illustration of working procedures and processes

(Dr. Jaroslava Paraskevova, MEDA Pharma GmbH & Co. KG, DE)

12:00 –

12:30

Best practice for the use of eCTD in MRP and DCP

(Mr. Kevin Wing, eCTDconsultancy, UK)

12:30 –

13:00

Experience gained during a test period of working with electronic

submissions at a national authority

(Mrs. Karin Gröndahl, Medical Products Agency, SE)

13:00 –

14:00

lunch break

14:00 –

14:30

Current status and future directions of PIM

(Mr. Timothy Buxton, EMEA European Medicines Agency, UK)

14:30 –

15:00

An applicant’s experience with a PIM submission

(Mr. Andrew P. Marr, PhD, GSK, UK)

15:00 –

15:30

The experience of a PIM submission: the agencies’ perspective

(Mrs. Claire Holmes (Edwards), EMEA European Medicines Agency, UK)

15:30 –

16:00

coffee and tea break

16:00 –

16:30

Successful transitions – a focus on eCTD

(Mr. Farouk Bouaziz, Thomson Scientific, UK)

16:30 –

17:00

Lifecycle Management considerations from a multiple country perspective

(Mr. Erick Gaussens, Product Life SARL, FR)

17:00 –

17:30

Building US NDA and Canadian NDS submissions based on European

eCTDs

(Mr. Ted Hanebach, CanReg Inc., CAN)

17:30 –

18:00

HL7 Regulated Product Submissions (RPS) and the ICH eCTD

(Mr. Andrew P. Marr, PhD, GSK, UK)