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2015 Speaker Faculty
Juha-Pekka Nenonen Director, Information Resources Finnish Medicines Agency
Alastair Nixon Director, Global Submission Production, Pharmaceuticals GlaxoSmithKline Research & Development Limited
Thomas Wimmer Regulatory Affairs Specialist/ Submissions Vifor Pharma Ltd
Thomas Strömquist Regulatory Operations Manager Swedish Orphan Biovitrum
Millennium Gloucester Hotel
Millennium Gloucester Hotel
Experience Exchange
Experience Exchange
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7 International and EU Regulators

 

Including: MCC (South Africa), Thai FDA (Thailand), MHRA (UK), Fimea (Finland), AFMPS (Belgium)

Globalisation of eCTD

Latest developments, experiences and future progress on eCTD in: GCC, Oman, Saudi Arabia, South Africa, Thailand, ASEAN and the US

Latest on EU Telematics

Including latest on the EU eSubmissions Roadmap, the electronic Application Form and the new PSUR repository

Networking and experience sharing

3 highly interactive sessions: 2 Interactive Experience Exchanges and a Top Table Panel Discussion

 

The 11th Annual Global eCTD Management Conference

Latest on global progress towards eCTD, EU telematics and industry benchmarking for eSubmission process optimisation

What is New for 2015?

  • Focus on new global regions exploring latest developments and progress on eCTD in the Gulf Coast Council (GCC), Oman, Thailand and the US
  • Direct feedback from the Medicines Control Council on the eCTD pilot project in South Africa
  • Practical industry case studies into submissions process optimisation followed by an interactive evening experience exchange
  • Understand the new PSUR repository and the implications for industry submission teams
  • Examine the implications of the new EU Clinical Trial Regulation (Regulation No 536/2014) on submissions and publishing teams

Interactive seminars

Make the most of your time away from the office...

 

Pre-conference evening seminar:
Discovering the latest developments, practicalitiess and implications of eCTD v4.0/RPS click for more info

Evening Experience Exchange:

Case Study Experience Exchange click for more info 

Who will you meet?

Meet, network and make new contacts with the following professionals…

Heads, Senior Managers, Managers, Publishers, specialists from:

  • Regulatory operations
  • Submissions
  • Publishing
  • Regulatory affairs 
  • Regulatory Information
  • Dossier submissions & management
  • Document management


Delegates attend from large, medium and small pharma, biotech and generics companies

Why should you attend? Take a look at the conference highlights to find out.

Event Sponsors

Event Sponsors & Exhibitors
Event Sponsors & Exhibitors
Event Sponsors & Exhibitors
Event Sponsors & Exhibitors
Event Sponsors & Exhibitors
Event Sponsors & Exhibitors
Event Sponsors & Exhibitors

Testimonials

"A great opportunity to get an insight into how other organisations are working with eCTD"
Speaker 2014, MHRA
"Informative conference with a good range of attendees from all areas of industry and authorities"
Delegate 2014, AbbVie

Other Events That Will Interest You

5th Annual

Analytical Method Development, Validation and Transfer

15 Sep 2015 - 16 Sep 2015
Maritim proArte Hotel, Berlin, Germany


Global eSubmissions

27 Oct 2015 - 29 Oct 2015
Hotel Palace Berlin, Berlin, Germany


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Event Sponsors & Exhibitors

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Media Partners

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