2nd Successful eCTD Lifecycle Management
|Event Date/Time: Sep 14, 2010||End Date/Time: Sep 15, 2010|
Pharma IQ is delighted to announce the 2nd Successful eCTD Lifecycle Management conference, being held in Prague on the 14th and 15th of September 2010.
With eCTD submissions taken a firm hold in the US and Japan, they are now making their mark in Europe. Now eCTD submissions are becoming the preferred format for regulatory submissions in Europe so it is essential that you are equipped with in-house expertise and external solutions to ensure first time compliance and submission success!
This is a challenging area for all and is not something that can be easily avoided. This is your chance to hear from thought leaders and uncover the latest regulations and thinking surrounding eCTD, both now and in the not to distant future.
Hot Topics You Will Discuss Include:
â€¢ Harmonising document management globally, representation from the US and Europe
â€¢ Migrating to New Submission Processes: Migrating to the PIM System, EFPIA Standards and Practical Pfizer Case Studies
â€¢ Getting the dossier right first time: Uncovering best practice in the development of local and centralized dossiers
â€¢ Managing different submission forms such as MRP and DCP
â€¢ Establishing best practice when implementing eCTD across the wider business: How to approach both the roll-out and internal training that is required for smooth adoption
The event already has the following confirmed speakers:
â€¢ Karin Grondahl, Head of Unit, Registration and Information Management, Sweden Medical Agency
â€¢ Dr Andrew Marr, Director, e-Regulatory Development, Global Regulatory Operations, PIM Steering Committee Co-Chair, EFPIA
â€¢ Dr Klaus Menges, Division Strategy and Planning - Unit Scientific Quality Assurance and Process Organisation, Federal Institute for Drugs and Medical Devices, Bfarm
â€¢ Lynsey Flitton, Senior Regulatory Labelling Manager, Pfizer
â€¢ Jean Paul Smith, Senior Manager, Regulatory Affairs, Celgene
â€¢ Dr Claudia Zerobin Kleist, MHA, Case Manager, Swiss Agency for Therapeutic Products (Swissmedic)
â€¢ Laura Barrett, Regulatory Publishing, GSK
â€¢ Martina PustÄ›jovskÃ¡, eDMS Project Manager, Zentiva
For more information and to download the agenda please visit the website www.ectdevent.com/prague, you can also call us on +44 (0)207 368 9300 or email firstname.lastname@example.org.