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Latest tweets:
InformaRegulatory >profile  Hear feedback from ISO TC 215 committee members and companies at the forefront of #IDMP implementation #RIM2015 http://t.co/7133yoxwcm 10 hours ago. · reply · retweet · favorite
InformaRegulatory >profile  New Day 3: Licensing and Collaboration Agreements for commercial and transactional lawyers #pharmalaw 19-21 may http://t.co/MB9SnjBO30 12 hours ago. · reply · retweet · favorite
InformaRegulatory >profile  RT @QUMAS : Enjoying Tine Vermeulen, PlanPharma making her presentation on eCTD in Oman at the @informa_regs event in London. http://t.co/ba yesterday. · reply · retweet · favorite
InformaRegulatory >profile  Ending day 2 of #eCTD2015 with an interactive experience exchange on regulatory publishing tools and systems yesterday. · reply · retweet · favorite
InformaRegulatory >profile  GSK provide a valuable insight into successfully managing global changes presented by the adoption of eCTD #eCTD2015 yesterday. · reply · retweet · favorite
InformaRegulatory >profile  Ending the morning sessions with an interactive panel reflecting on the EU eSubmissions roadmap #eCTD2015 yesterday. · reply · retweet · favorite
InformaRegulatory >profile  Comprehensive insight into EU Telematics this morning with insight from Pfizer and Teva #eCTD2015 yesterday. · reply · retweet · favorite
InformaRegulatory >profile  Finishing the afternoon in London with an interesting insight into submissions process optimisation #eCTD2015 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Understanding US eCTD submissions, portals and recent changes to Module 1 #eCTD2015 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Thai FDA provide a valuable insight into eCTD submissions in Thailand 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Stefano Marino of @EMA_news will speak on Transparency of clinical trial and regulatory data #pharmalaw 19-21 may http://t.co/xkavbyJPto 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Interesting insight from the MCC on the eCTD pilot project in South African #eCTD2015 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Starting this year's meeting with an insightful look at eCTD across the GCC #eCTD2015 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Valuable insight into eCTD in Oman this morning: What is to come and when? #eCTD2015 2 days ago. · reply · retweet · favorite
InformaRegulatory >profile  #RIM2015 Gain insight into info mgmnt beyond regulatory. Assess integration of CMC changes, pharmacovigilance + RIMs http://t.co/h0jPu7bAci 3 days ago. · reply · retweet · favorite
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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
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Testimonials

"Informative conference with a good range of attendees from all areas of industry and authorities"
Delegate 2014, AbbVie
"Rich content on all hot topics"
Delegate 2014, Sanofi Pasteur

Other Events That Will Interest You

Global eSubmissions

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


Regulatory Affairs in Emerging Markets

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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