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

4

“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

5

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

9

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

18

Thank You

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