OPENeCTD formerly - Extedo

formerly
OPENeCTD
Agenda: Wednesday, 13 April 2011 – Day 1
08:00 – 09:30
09:30 – 09:45
09:45 – 10:15
10:15 – 10:45
• Registration
• Opening eRA2011 – Tore Bergsteiner & Martin Schmid
• Electronic Submissions in Europe – EMAs Roadmap and Vision – Hans Georg Wagner (European Medicines Agency)
• eSubmission: The Good, The Bad, The Future – Michael Schaub (Regulatory Pharma Net)
10:45 – 11:15 Coffee Break
11:15 – 12:00
12:00 – 12:30
• Your eRegulatory World – Winds of Change – Steve Scribner (International Life Science Solutions)
• Current Status of Electronic Regulatory Affairs Standards in Europe – Vito Strasberger (Nanokinetik)
12:30 – 14:00 Lunch – sponsored by ProductLife
14:00 – 15:30 A1 Submission Planning & Tracking – How to manage
registrations
• B.Braun´s View on an Integrated Regulatory
Application Landscape and How to Get There –
Harald Weis (B.Braun)
• Swissmedic‘s Submission Tracking and Reviewing
Now and in the Future – What is in it for the
Applicants? – Susanne Kienberger (Swiss Authority,
Swissmedic)
• Submission Planning & Tracking of Agency
Communication – Ruedi Blattmann (Life Science
Consulting Partners, LSCP)
B1
EU-Regulation & Validation
• Validation of eCTD and NeeS – An Industry
Perspective – Alastair Nixon (GSK)
• The Improved Validation Criteria – Karin Gröhndal
(Swedish Authority, MPA)
• e-Submission Validation in Europe – Balancing National
Agencies‘ Requirements with an Applicants‘
Desire for a Harmonized Dossier – Karl-Heinz
Loebel (Pharmalex)
C1
Sponsoring Partner Track
• Managing Electronic Submission Documents and
Correspondence – Cyril Walsh (QUMAS)
• From Paper-Dossier to eCTD – Andreas Treptow
(Optimal Systems)
15:30 – 16:00 Coffee Break
16:00 – 17:30 A2 Customer Success Stories
B2
Worldwide Standards and Interoperability
C2
Sponsoring Partner Track
• How to Replace Three Legacy eSubmission
Systems with a New One – Adam Aparicio (Merck)
• Global eSubmission management – act local and
and think global – the Angelini Group experience –
Maria Angela Gatto (Angelini)
• CanReg’s eCTD Success Story and Lessons
Learned – Ted Hanebach (CanReg)
• Introduction to the IRISS Forum (Implementation
of Regulatory Information Submission Standards) –
Deanna Murden (ePharmaCMC, LLC)
• An Update on the IRISS ETICS III Project: The EU
Arm of the Study – John-Paul Smith (Celgene)
• Electronic Submissions in the Far East –
Harv Martens (EXTEDO)
• Sharepoint Validation Services – Klavs Esbjerg
(Epista IT)
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT
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