Strategy and Management for Successful Global Submission
Jessie Y. Lee, Ph.D. RACManager, Quality Management, Global Regulatory Affairs
September 18, 2015Taipei, Taiwan
2015 International Good Submission Practice Workshop on Pharmaceuticals
Takeda History
2
Takeda Global Footprint
ExportFootprint
30,000+employeesworldwide
#1pharmaceutical
company in Japan
70+countries with Takeda market
presence
3
Takeda by the Numbers
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“It is not the strongest of the species that survive,
nor the most intelligent,
but the one most responsive to change.”
- Charles Darwin
Mentality – Manage Change
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Key Success Factors
Electronic Submission
Core Competence
Agenda
6
CommunicationKnowledge of
Regulatory Requirements
Global Filing Strategy IT Systems
Key Success Factors
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Regulatory Lead
Project Team
Local Regulatory
Representative
Regulatory Authorities
Communication
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Project Team Multidisciplinary
(Clinical, non-clinical, CMC, Regulatory, Medical, Marketing)
Determine Submission Timeline, Region, Country
(MAA, NDA)
Pre-Submission Meeting with Regulatory Authority
(Clinical, CMC, eCTD)
Meet with Regulatory Authority
(Pre-IND, Pre-NDA, Consultation)
Check Guidance Document
Initial Project Planning
Yes No
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Guidance Documents
Country-specific
Registration
Bridging Studies
CPP
eCTD Module
M1 -Ancillary
M2-M5: Stability,
GMP
Site Registration,
Sample
Regulatory Authority Meetings
Pre-submission
Meeting
Advisory Committee
Meeting
Other Consultation
Meeting
Knowledge of Regulatory Requirements
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• Country-specific Registration Information
Module 1
• Overview Summary for Quality, Clinical and Nonclinical
Module 2
• CMC on Drug Substance and Drug Product
Module 3
• Nonclinical Studies
Module 4
• Clinical Studies
Module 5
ICH eCTD Format
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Staggered Submission
Parallel Submission
Global Filing Strategy
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• Clinical Development, clinical trials• File format and content• Translation• Label• Sample• Life cycle management
Consideration Points – Submission Strategy
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Integrated Electronic Document Management System (EDMS)
Global Tracking , Global Submission Viewer Publishing Tool
Nycomed
MillenniumTakeda
IT Systems
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Harmonized all processes across all regions
Standardized EDMS to houses all approved submission documents
Use the same tracking, review and publishing tool to allow work sharing globally
Can clone for other submissions efficiently
Standardized IT Framework
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Team review Documents
• Define roles and responsibilities in multidisciplinary team• Create new document templates• Team review/QC and approve all documents for submission
Development of Submission
• Establish database for regional requirements• Agree on Submission Table of Contents (eCTD) • Develop Submission Tracking Timeline
Preparation of eSubmission
• Standardize submission QC process• Check bookmarks and hyperlinks• Compile and publish submission
Submission to Regulatory Authority
• Send submission electronically• Receive acknowledgement of the submission• Alternatively, provide CD for paper submission
Preparation of Submission
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Identify the purpose of the process
Clarify the Scope and Limitation
Conduct the Process Map – Identify “Who is Doing What”
Reach agreement with all relevant stakeholders
Place the SOP in the controlled system and implement after training
SOP Development
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Communication Leadership
Organization Skill Quality
Teamwork
Core Competence
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Thank You
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