A RAPS interactive seminar and hands-on workshop­--learn by doing

Are your skills up to date with FDA’s new electronic submission requirements?

FDA’s Center for Drug Evaluation and Research now mandates the use of the electronic Common Technical Document (eCTD) format for all electronic submissions to the Center for Drug Evaluation and Research (CDER) and is taking steps to mandate the same format for communications with all Centers in the near future. The eCTD is rapidly becoming the required standard of regulatory authorities around the world.

Update your skills now and reduce your chance of a Refuse-to-File action.

Attend the Preparing Compliant eCTD Submissions interactive workshop and walk away with a comprehensive technical knowledge of the tools, techniques and processes required to complete an eCTD submission.

This intensive workshop is comprised of two full days of skill-building, interactive exercises and valuable resources. Learn the standardized submission procedures by putting them into practice.

Learn to:

• Assess your company’s resources and business policies with regard to records and document management
• Gain hands-on experience with software used to generate electronic submission content
• Successfully produce and evaluate eCTDs to lessen the chance of Refuse-To-File (RTF) action by FDA
• Utilize the leading eCTD publishing systems
• Decipher acronyms and master the jargon surrounding eCTD and electronic submissions