A major part of the conference are Presentations given by Industry and Agencies, which could be considered as continuous education for Regulatory Affairs professionals.

Network with not only other colleagues from the industry working in the same regulatory area, but also with representatives from several of the world health authorities which are also adopting electronic submission standards.

The Table Top Tutorials are another part of the conference, allowing conference attendees the opportunity to participate in concise, detailed, 1-hour sessions focusing on one specific topic.

This year’s userBridge.12 conference will be held at the Hotel Clontarf Castle in Dublin, Ireland.

LEARN

INTERACT

The LORENZ user conference basically acts as a communication platform for people working in the Regulatory Affairs Area.

DISCUSS

8:009:00

Registration 8:309:00

EVMPD - Good Regulatory PracticeKarl-Heinz Loebel - PharmaLex GmbH

8:309:00

International Standards: Develop your own! Business drivers to support multiple international standardsSpeaker:Hans van Bruggen - eCTD Consultancy

9:009:30

Introduction Speaker:Raoul-A. Lorenz - LORENZ Life Sciences

9:009:30

CESP, Central European Submission PortalSpeaker: Kevin Horan - IMB

9:009:30

Regulatory Considerations

9:3010:00

Worlwide dB OperationsSpeaker: Dr. Dietmar Böcker - Bayer HealthCare AG

9:3010:00

GCC & SFDA eCTD StrategySpeaker: Saleh Zomia - SPIMACO

9:3010:00

Regulatory Considerations

10:0010:45

BREAK 10:0010:45

BREAK 10:0010:45

BREAK

Preliminary Agenda June 2012

REGISTER

Please note that LORENZ reserves the right to modify the agenda and/or list of speakers.

Preliminary Agenda June 2012

10:4512:15

LORENZ Life Sciences Group

10:4511:15

Dawn Kelly - Johnson & Johnson Consumer Companies, Inc. Title: TBD

10:4511:45

e-Regulatory ForumHow many different portals can a pharmaceutical company manage?11:15

11:45Results of RPS / eCTD 4.0 Survey - Potential Impact on eSubmission in EU/USSpeaker: Sybille Teuchmann - Exalon GmbH

11:4512:15

EVMPD UpdateSpeaker: Andrew Marr - AM Consulting

11:4512:00

Final Words Speaker:Raoul-A. Lorenz - LORENZ Life Sciences Group

12:1513:45

LUNCH 12:1513:45

LUNCH 12:0013:45

LUNCHEND OF CONFERENCE

13:4514:15

LORENZ docuBridge as an enabler for collaborating and achieving the individual domestic health benefits of world agenciesVikesh Srivasta - Health Canada

13:4514:35

Table Tutorials Session 1- ASMF‘s- Features in docuBridge- Agency Round table- Setting up and using the FDA Gateway and more....

14:1514:45

eCTD and eQMS: How Solutions work together in a Life Sciences CompanyEricka Moore - Solabs

14:3514:40

5 MIN. BREAK

14:4515:15

The art of avoiding the ‚Resubmit‘ - Updated PDF Validation requirements in FDA eCTD 2.1Brian Kernohan - Adlib Software

14:4015:30

Table Tutorials Session 2- From dB 3.6 to dB5.0 - eValidator issues- drugTrack - Embracing the future: transitioning the user to dB 5 and more ...

15:1516:00

BREAK 15:3016:00

BREAK

16:0016:30

ETICS III Bryan Ennis - NextDocs

16:0016:50

Table Tutorials Session 3- Medical Devices- NeeS- Submittting in Russia- EVMPD- Making sure your documents are eCTD-ready and more ...

16:3017:00

Sherry Kremidas - RAPSTitle: TBD