Description
eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. In July 2009, the EMEA have made it clear that paper and other electronic formats will be an exception to the general e-CTD format recommended for any application. As it is not limited to the transfer of information it also applies to the creation, review, life cycle management and archival of electronic submission. Hence, drug manufacturers must consider new methodologies and adapt their organisation to change.
By attending this conference, you will:
Discuss emerging trends in electronic submissions in the US & Europe, Filing CTDformatted
Identify challenges and benefits of transitioning to eCTD
Hear the various methods of submitting electronic submissions to global health authorities
Learn how to manage the lifecycle of an eCTD
Understand if outsourcing is a rapid, cost-effective option for electronic submissions
Recognise the vital role of good document management and best business practices in the overall process of preparing the eCTD
Describe the role of eCTD standards and analysing their impact to the development/delivery process.
