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InformaRegulatory >profile  Who can you expect to meet at Pharmaceutical Packaging 2014? http://t.co/mg8LkhYE1v #pharmapackaging 6 hours ago. · reply · retweet · favorite
InformaRegulatory >profile  Case study from @pfizer on practically implementing serialisation Master Data: http://t.co/8fpSmyOeYx #pharmapackaging yesterday. · reply · retweet · favorite
InformaRegulatory >profile  Who can you expect to meet at 2014's Pharmaceutical Packaging? http://t.co/8JQBeMTUN8 3 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Top 10 reasons to attend Pharmaceutical Packaging: http://t.co/DAB7KwHwM5 #pharmapackaging 4 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Get the latest regulatory updates & industry case studies for pharmaceutical packaging incl. update on EUFalsified Medicines Directive 5 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Hear from @AbbottNews @RocheDiaUK & many more at #Labelling 2014 5 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Register before Friday 26th Oct to save on your place at Labelling 2014! http://t.co/sJxvwoG8uw #Labelling2014 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Get an update on the European Falsified Medicines Directive at #PharmaPackaging. Check out the rest of the higlights: http://t.co/4kTeIhbl8k 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Gain practical advice for registering a product in China,Korea, ASEAN countries and the Asia-Pacific region #RegAffEE http://t.co/WN5aVLh6bv 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Examine the structure and processes of regulatory publishing teams at Gilead, MerckSerono, and Eisai http://t.co/HDnO9QQocO 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Register for DDCP today and save up to £100! http://t.co/lfHVSju7at #DDCP2014 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Hear from leading industry experts on key packaging topics incl: @AstraZeneca @pfizer @sanofi at Pharmaceutical Packaging #pharmapackaging 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  New topics for 2014: -UDI implementation -Symbols harmonisation -Labelling in Brazil, China, Rusia & CIS #Labelling2014 6 days ago. · reply · retweet · favorite
InformaRegulatory >profile  Quick stats for the Pharma& MedDev Labelling & Packaging Summit: 45+ speakers CPD accredited 160+ attendees predicated 7 days ago. · reply · retweet · favorite
InformaRegulatory >profile  The borderline between medical devices & medicinal products: viewpoint from European Competent Authority. #FREE download #DDCP2014 7 days ago. · reply · retweet · favorite
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Expert speaker faculty
Mickel Hedemand Internal Adviser, Licensing Division Danish Health and Medicines Authority (DHMA)
Klaus Menges Director Federal Institute of Drugs and Medical Devices (BfArM)
Matt Hillier Submission Centre Team Lead, Information Processing Unit MHRA
Miguel Bley European Affairs Coordinator, ANSM
Regulatory agencies
Miguel Bley European Affairs Coordinator, ANSM
Dr Klaus Menges Head of the Unit Scientific Quality Assurance and Process Organisation BfArM
Mickel Hedemand Internal Adviser, Medicines, Regulation & Marketing Authorisations Danish Health and Medicines Authority (DHMA)
Matt Hillier Submission Centre Team Lead, Information Processing Unit MHRA
eCTD Seminars

Evening Seminar

Key event features:

Key Features

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7 International Regulators

Including: Saudi FDA (Saudi Arabia) MHRA (UK), DHMA (Denmark), ANSM (France), Fimea (Finland), BfArM (Germany), SUKL (Slovakia)

EU telematics initiatives

Latest updates, developments and experiences on:

EU eSubmissions Roadmap, eCTD 4.0, CESP, EMA Gateway, eAF & eSignatures...

Globalisation of eCTD

Hear the latest developments, experiences and future progress on eCTD in:
- Saudi Arabia (from Saudi FDA)
- ASEAN
- South Africa & Australia

Networking and experience sharing

3 new interactive sessions: The Experience Exchange, Top Table Panel Discussion & EU Telematics World Café

 

The 10th Annual Global eCTD Management Conference

Europe’s only electronic submissions conference for eCTD

Essential telematics updates, regulatory agency feedback and opportunities for sharing industry experiences on global eCTD challenges.

Save the date for 2014’s leading conference for regulatory affairs and operations teams working with eCTD. Join industry experts and regulatory authority representatives as they share their experience across key developments and challenges surrounding eCTD.

Interactive seminars

Make the most of your time away from the office and book a seminar place...

 

Pre-conference evening seminar: Monday 24 February 2014

Communicating eCTD requirements to ensure submission ready documents

 

Led by: Lone Bo Sisseck, Regulatory Associate, Novo Nordisk AS, Denmark
Anne Westh, Regulatory Associate, Novo Nordisk A/S, Denmark
Phoebe Naveed, eSubmission Manager, Global Regulatory Affairs, Linde Healthcare AB, Sweden

 

 

Evening seminar: Tuesday 25 February 2014

eCTD 4.0 Progress update and implementation considerations: What can industry expect and when?

 

Led by: Klaus Menges, Director, Federal Institute of Drugs and Medical Devices (BfArM), Germany
Andreas Franken, Head of Clinical Research, Manager eSubmission, German Medicines Manufacturers Association (BAH), Germany

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 Countdown

 

Other Events That Will Interest You

24th Annual EU Pharmaceutical Law Forum

20 May 2015 - 21 May 2015
Hotel Metropole, Brussels


CPD Accredited

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Event Sponsors & Exhibitors

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Media Partners

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