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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
Feature Presentations

eCTD in Oman: Discussing what is to come and when?

 

Hear the latest on plans, guidance and timings for eCTD in Oman

MCC feedback on the eCTD pilot project in South Africa

 

First hand regulatory feedback from the Medicines Control Council, South Africa

Examining the EU eSubmissions Roadmap: Finalising the future of eSubmissions in Europe

 

Benefit from latest updates from the Finnish Medicines Agency

Implications of the new EU Clinical Trial Regulation (Regulation No 536/2014) on submissions and publishing teams

 

What is the relevance for submissions teams?
Workshop and Seminar

 

 

 

Pre-conference workshop: Monday 23 February 2015

Preparing, submitting, validation and maintaining eCTD submissions


 

Pre-conference evening seminar: Monday 23 February 2015

Discovering the latest developments, practicalities and implications of eCTD v4.0/RPS

2014 Testimonials
"Informative conference with a good range of attendees from all areas of industry and authorities"
Delegate 2014, AbbVie
"Great opportunity to hear about the global process of eSubmissions"
Delegate 2014, Chiesi Pharmaceuticals
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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 officee...

 
Pre-conference workshop day:

Preparing, submitting, validation and maintaining eCTD submissions click for more info

 

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.

Dates and Venues

24 Feb 2015 - 25 Feb 2015

Millennium Gloucester Hotel, London Kensington

Testimonials

"Informative conference with a good range of attendees from all areas of industry and authorities"
Delegate 2014, AbbVie
"Great opportunity to hear about the global process of eSubmissions"
Delegate 2014, Chiesi Pharmaceuticals

Speakers Include

Speakers Include

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


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Event Sponsors & Exhibitors

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