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Introduction

This course will offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting electronically.

Highlights:

• Overview of eCTD readiness at the agencies
• Impact of the eCTD on regulatory processes and procedures
• Practical experience of submitting an eCTD in the EU
• eCTD compilation and life cycle
• Document granularity and readiness
• Regulatory strategy facing technical issues
• Specifications and standards versus regions and procedures

Venue

Dorint Praha Don Giovanni Hotel

Dorint Praha Don Giovanni Hotel, Vinohradska 157a, Prague, Czech Republic

Useful links

Organised by

Drug Information Association

Contact information

Mr Senior Manager of Marketing
Europe, DIA, Postfach, Basel, 4002, Switzerland
+41 61 225 51 51
Contact us by email

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