- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Global eCTD Management
27 - 28 February 2013
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Dr Karen Friedrich-Voss Regulatory Operations Manager Merck KGaA
Mickel Hedemand Internal Adviser, Medicines, Regulation & Marketing Authorisations Danish Health and Medicines Authority (DHMA)
Hans van Bruggen Director eCTD Consultancy
Pia Holm e-Submission Manager Ferring Pharmaceuticals -
Dr Pieter Vankeerberghen Head ICT Developments and Projects AFMPS
Juha-Pekka Nenonen Director, Information Resources Development, Finnish Medicines Agency
Matt Hillier Submission Centre Team Lead, Information Processing Unit MHRA
Mickel Hedemand Internal Adviser, Medicines, Regulation & Marketing Authorisations Danish Health and Medicines Authority (DHMA) PRACTICAL ADVICE
...on outsourcing regulatory publishing tasksINTERACTIVE SESSIONS
...Successfully managing eCTD complexities - speakers and delegates can highlight challenges and questionsSTAKEHOLDER FEEDBACK
...on the validation criteria, similarities and differences to eCTD critiera, changes to folder structure and hyperlinkingGLOBAL PANEL
...discussion on recent progress towards eCTD in Australia, Saudi Arabia and GCC and Russia
Meet & network with 4 EU regulatory agencies, including:
MHRA (UK)
DHMA (Denmark)
AFMPS (Belgium)
Fimea (Finland)
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:
Australia
Saudia Arabia
GCC
Russia and the US
Discuss EU harmonisation on eCTD, including:
Module 1
eCTD in MRP and DCP
Eliminating paper
Global eCTD Management
Europe’s only electronic submissions conference for eCTD
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.
Conference Highlights
Interactive sessions
Conference sessions will include:
- Key developments, progress and experience from EU telematics initiatives
- Regulatory agency requirements, experience and expectations from eCTD submissions : The EU Regulatory Authority viewpoints
- EU Harmonisation
- Globalisation of the eCTD
- Outsourcing regulatory publishing tasks
- Streamlining MRP and DCP practices
- New challenges and practical experience presented by the new eCTD validation criteria v4.1 and NeeS Validation Criteria v3.0
- Planning for eCTD lifecycle management
- Changes to eCTD in the USA
- PDF version use in eSubmissions
- Optimising information re-use between submissions
- Communicating eCTD requirements to ensure submission ready documents
Who should attend?
- Regulatory Affairs Managers
- Product Registration Managers
- Classification Managers
- Labelling Managers
- Toxicologists
- Scientific Officers
- EU Policy Directors
- Senior Regulatory Managers
- R&D specialists
- Chemists
- Heads of Regulatory Services
- Heads of Risk Assessment
- Directors of REACH
- Inspectors
Interactive problem solving session – Designing a compliant label
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.
Event Sponsors
Exhibitors
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This Conference is CPD Certified
Event Sponsor
Spotlight Sponsors
Exhibitors
Promotional Participants
eRegulatory Series Sponsors
Media Partners
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