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Session 7 Track 3: Regulatory Submissions: Special Requirements in Europe and China
Session Chair(s)
Joanne Malia, MS, MSc
Director, Development Records Management
Regeneron Pharmaceuticals, United States
This session will highlight regulatory submissions in Europe and China, and requirements that must be met to be successful. The speakers will include examples to put these requirements into context, including discussing what is essential in preparing and submitting to Europe and to China’s new electronic common technical document (eCTD) specification. This session will acquaint attendees on the skills and procedures necessary for regulatory submissions in these regions, including challenges and matters to consider.
Learning Objective : - Recognize key requirements in regulatory submissions in Europe and China
- Describe how to meet those requirements within submissions
- Formulate courses of action for your organization and next steps to prepare for successful submissions to these eCTD regions
- Interpretation on China eCTD technical requirements, specifications, and main characteristics
- Practice the new eCTD 4.0 submission standard for Europe
Speaker(s)
eCTD 4.0 Requirements for Europe
Gerhard Neurauter, DrSc
EXTEDO, Germany
Director Regulatory Competence
Ready, Set, Go! Adapting and Adopting to the Recent Regulatory Submission Announcements in China
Rob Labriola, MS
Garuda Therapeutics, United States
Exec. Director, Regulatory Operations
Sophia Huang
PharmaLex, Taiwan
Executive Director