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eCTD Submissions

Practical solutions for managing global regulatory requirements and new challenges

26 - 27 September 2017

Radisson Blu Edwardian Grafton, London

Filing new submissions is a time consuming, laborious task for both industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the process. Using the eCTD has been proven to speed your data through the approval process, saving you valuable resources and time.
Global regulatory agencies are committed to implementing the eCTD as standard. Attend this practical 2-day course and ensure your applications are in the correct electronic format and style from the onset.

  • Establish more efficient processes to build, publish and deliver your regulatory submissions
  • Meet the challenges of adopting the eCTD on a global scale
  • Clarify regulatory requirements and improve your agency communications
  • Track and manage multiple agency submissions with effective life cycle management
  • Identify the latest challenges presented by the new eCTD validation criteria

 

 

 

 

Regulatory Affairs and Operations

  • Dossier Management
  • Document Management
  • Data Management
  • Compliance
  • Electronic Publishing/ Submissions
  • Global Project Management
  • IT/IS
  • EDMS

Having finished his degree in Chemistry at Heidelberg University, Germany, Karl-Heinz Loebel joined a Biotech startup company as Scientific Advisor and Management Executive for several years. In early 2005 he joined PharmaLex International and was recently promoted to Head of Regulatory Operations.

Silke Nolkemper studied pharmacy and holds a PhD in Pharmaceutical Biology from the University of Heidelberg, Germany. She has more than 7 years’ experience as Regulatory Affairs Manager in the pharmaceutical industry spending time at PharmaLex, Sandoz/HEXAL and finally Extedo where she is responsible for the implementation of regulatory updates regarding eSubmission (eCTD, NeeS, eCopy, VNeeS, ASMF, DMF).

eregulatory summit colour

eRegulatory Summit

25 – 27 April 2017 | Madrid, Spain

Connecting RIM, IDMP and eCTD professionals to drive regulatory strategies through authority access and industry expertise. Summit topics include:

Regulatory Information Management & IDMP Compliance
Global eCTD Management
Filing Variations

If you would like to find out more about the eRegulatory Summit, please click here.