PRACTICAL ADVICE...on outsourcing regulatory publishing tasks
INTERACTIVE SESSIONS...Successfully managing eCTD complexities - speakers and delegates can highlight challenges and questions
STAKEHOLDER FEEDBACK...on the validation criteria, similarities and differences to eCTD critiera, changes to folder structure and hyperlinking
GLOBAL PANEL...discussion on recent progress towards eCTD in Australia, Saudi Arabia and GCC and Russia
"As new to eCTD management: A great introduction to the many aspects and challenges in eCTD"
"Excellent cross section of the EU eCTD landscape in an intimate setting"
Meet & network with 4 EU regulatory agencies, including:
Latest updates, developments and experiences on:
eCTD 4.0, CESP
Central Repository, eAF,
EMA Gateway ...
Hear the latest developments, experiences and
future progress on eCTD in:
Russia and the US
Discuss EU harmonisation on eCTD, including:
eCTD in MRP and DCP
Save the date for 2013’s leading conference for regulatory affairs and operations teams working with eCTD. The main objective of 2013’s conference is to share practical experience across a range of European and Global publishing team challenges.
The conference will address EU telematics initiatives, Regulatory agency feedback on eCTD applications and management, globalisation of eCTD and key common everyday submission challenges. Join industry experts and regulatory authority representatives as they answer the most essential questions currently facing industry practitioners.
You can expect an expert speaker faculty and delegate audience consisting of: Heads, Managers, Senior Associates and Associates from Regulatory Operations, Publishing, Regulatory affairs, Submissions and Registration in addition to Regulatory authorities.
Focusing on the problems experienced with multilingual labelling, small labels and labels for consumer products this session has been designed so that you can discuss all of the labelling issues faced by your industry.