Electronic Document Management Summit on MOSS 2007
A new perspective on eCTD and GMP compliance
Electronic Document And Regulatory Management on MOSS 2007
When: Tuesday 24th November 2009
Where: IBM House, Southbank, London
Time: 13:30 - 18:00
The biopharmaceutical sector is challenged with increasingly stringent requirements for the management and submission of electronic documents. The growing need for e-submission capability coupled with more open platform document management options are creating new opportunities for creating value through increased efficiency.
This half-day partner summit will give attendees a detailed overview of current best practices in the compliant management of documents. Independent industry experts will elaborate on scenarios, common practices, and agency expectations for submission related content and the compliant management of SOPs. This summit will show how best of breed solutions from different vendors can be put together efficiently to create user friendly solutions for the management of documents in R & D and Manufacturing.
Meet with colleagues from the industry facing similar problems and learn how software and process optimization can be put to work for the success of your business and product line. Anyone who has to handle compliant documents will benefit from this event; our experienced and knowledgeable speakers will give an insight into best practice for electronic document management and regulatory submissions. The order of events is to be as follows:
Time |
Speaker |
Detail |
13:30 - 13:45 |
Arrival |
Tea and coffee |
13:45 - 14:10 |
Keith Williams (Good Products) |
Introduction of the document management landscape and MOSS 2007 as an eDMS |
14:10 - 14:35 |
Rob Stephenson - (Pfizer Regulatory Systems Team Leader) |
Large Customers perspective on eDMS implementation |
14:35 - 15:00 |
Ruth Stone (Stonework Consulting) |
Document management- getting it right to ease the regulatory submission- a consultants perspective |
15:00 - 15:25 |
Jeanette Greef (Thomson Reuters) |
Efficient Compliant Submissions: focus on Document Identification, Preparation and Tracking |
15:25 - 15:45 |
Break |
Tea and coffee |
15:45 - 16:10 |
Olaf Schoepke (Extedo) |
Regulatory submission process, challenges / pitfalls of eCTD for smaller businesses |
16:10 - 16:35 |
David Cornwell (Please Review) |
Reducing document preparation time by 65% with collaborative document review |
16:35 - 16:55 |
Rodd Schlerf (ARX) |
Digital Signatures & CoSign for simple compliant electronic signatures |
16:55 - 17:15 |
Peter Duff (Adlib Publishing) |
You have finished your document and you want to publish to .pdf or make a composite document |
17:15 - 17:35 |
Mark Stevens (GxP Consulting) |
Validating the integration of best of breed products to a usable eDMS on MOSS 2007 |
17:35 - 17:55 |
Panel Questions |
Q & A session |
17:55 - 18:00 |
Keith Williams (Good Products) |
Wrap up and Head to the Mulberry Bush for fine ales!! |
How to get there?
By Car
South Bank is less than half a mile from Waterloo station. From the main roundabout to the north of the station, take the Stamford Street exit and then first left into Cornwall Road. The IBM building faces you at the end of Cornwall Road.
Parking
There are public car parks close to South Bank, but they can be expensive. Meter parking is also available in the streets nearby. Parking for disabled drivers can be arranged by calling 020 7261 0618.
By train
Waterloo (BR), Waterloo East (BR) and Blackfriars (Thameslink) stations are all within walking distance. London's other mainline stations are within fifteen minutes by London Underground to Waterloo station. Travel information can be obtained from BR on 0845 300 7000 or Thameslink on 0845 330 6333.
By underground
Tube maps are available from most underground stations. Waterloo is on the following underground lines: Northern, Bakerloo, Jubilee and Waterloo and City. The Northern line has two branches, so make sure the train you board is going to Waterloo. The Waterloo and City line links Waterloo to Bank station on the Central line. Travel information for London Underground is available on 020 7222 1234.
On foot
Walking from the stations is straightforward, though you may prefer to take a taxi. IBM's South Bank building is located between the Royal National Theatre and the London Weekend Television Studios. From Waterloo, follow the signs from the station for the South Bank. Get to road level, York Road, and head north towards the rail bridge, bear left under the bridge, into Concert Hall Approach, heading for the Royal Festival Hall. Turn right onto Belvedere Road (which becomes Upper Ground as you walk under the bridge) past the Royal National Theatre, and IBM is on your left. From Waterloo East walk up Cornwall Road and IBM is opposite you. From Blackfriars, walk over Blackfriars Bridge, turn first right into Upper Ground and IBM is just past LWT Studios.
By taxi
London cabs are abundant; when their yellow taxi sign is lit they are available for hire. You can also hire taxis by phone on 020 7286 0286 or 020 7272 0272.
A list of secure car parks in London can be found here
