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Four Points By Sheraton Bur Dubai

Dec 12, 2016 8:00 AM - Dec 13, 2016 5:30 PM

Khalid Bin Walid Street, Bur Dubai P.O. Box 33196, Dubai, United Arab Emirates

Building the eCTD - Practical Solutions to Compiling Electronic Submissions

This course offers insight into the compilation of the eCTDs, experience and best practice gained during eCTD submissions and explains the eCTD review und lifecycle process.

Faculty

Karl-Heinz  Loebel

Karl-Heinz Loebel

Director, Principle Consultant Regulatory Operations, PharmaLex GmbH, Germany

Karl’s experience in positions of responsibility within regulatory operations spans a period of 6 years with particular focus on e-documentation and the associated systems that support the ability to manage and be compliant with the connected regulations. Highlights include his involvement in a global capacity providing counselling and support on optimisation of eCTD compilation and his current position which has seen him involved in working groups on current ISO issues faced by Eudravigilance and Regulatory professionals.

Olaf  Schoepke, PhD

Olaf Schoepke, PhD

Vice President, Regulatory Solutions, Samarind, United Kingdom

Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

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