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Good Registration Management

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2016 APEC Good Registration Management (GRM) regulatory Science Center of Excellence Pilot Workshop Draft Program

2016 APEC Good Registration Management (GRM) regulatory Science Center of Excellence Pilot Workshop Draft Program

DAY 1 |15 NOVEMBER

Time Topics Speakers
08:30-09:00 REGISTRATION
09:00-09:15 OPENING REMARKS Shiow-Ing Wu(TFDA)
Yeowon Sohn(AHC) - Video
GROUP PHOTO
Common Sessions
Session 1. Basic Concept of GRM
Chair: Li-Ling Liu (TFDA)

09:15-10:45

  • 1. Introduction
  • 2. Lecture 1: The APEC 2020 Roadmap to Promote GRM and the Curriculum Design of this Pilot Workshop
Li-Ling Liu (TFDA)
  • 3. Lecture 2: Background of GRM and high level principles and
  • processes of Good Review Practice (GRevP) & Good Submission
  • Practice (GSubP)
  • 4. Lecture 3: How to build quality onto the regulatory submission
  • and review process and how can these be measured?
Isao Sasaki (JPMA)
Prisha Patel (CIRS)
  • Q&A
10:45-11:00REFRESHMENT BREAK
Session 2. An Overview of Good Review
Chair: Florence Houn (FDAAA/Celgene)
11:00-12:30
  • 1. Introduction
  • 2. Lecture 1: WHO Good Review Practices Guidelines for Regulatory Authorities
    • Principles
    • Managing the Review
    • Communications
    • Personnel - Critical Thinking
    • Review Strategy
Florence Houn (FDAAA/Celgene)
  • 3. Lecture 2: The Challenge of Making Good Review Practices a Reality
Mark Goldberger (FDAAA)
  • 4. Lecture 3: Management of the Review and Quality System
Zing Zhang (FDAAA/Janssen)
  • Wrap up and Q&A
12:35-14:00LUNCHEON
Session 3. An Overview of Good Submission
Chair: Isao Sasaki
14:00-15:30
  • 1. Introduction - Why applicants need GSubP?
  • 2. What is “quality of submission”?
    - Practice with participants -
  • 3. Outline of GSubP Guideline for Applicants
  • 4. Summary
Isao Sasaki(JPMA)
15:30-15:45 REFRESHMENT BREAK
Session 4. Case study: Effective Communication for GRM
Chair: Kanako Takatsuki (PMDA)
15:45-17:15
  • 1. Introduction
  • 2. Lecture: Effective Communication for GRM
  • 3. Wrap up and Q&A
Eriko Yamazaki (PMDA)



2016 APEC Good Registration Management (GRM) regulatory Science Center of Excellence Pilot Workshop Draft Program

DAY 2 |16 NOVEMBER

Applicant-Specific Sessions
TIME SUBJECTS SPEAKERS/PANELISTS
09:30-10:00 REGISTRATION
Session A 1. Planning of Application
Chair: Jin Shun (AbbVie)

10:00-12:00

  • 1. Introduction
  • 2. What do we want
Jin Shun (AbbVie)
3. What do we need Thean Soon Lo (J&J)
4. How do we do it Sannie S.F. Chong (Roche)
  • 5. Q&A
  • 6. Case Study
Jin Shun, Thean Soon Lo & Sannie S.F.Chong
12:00-13:00LUNCHEON
Session A2. Preparation of applicant dossier/Practice: How to prepare application dossier
Chair: Shinji Hatakeyama (JPMA)
13:00-17:10
  • 1. Introduction
  • 2. Ice-Breaking Game
Shinji Hatakeyama (JPMA)
3. Dossier Preparation Mari Toji (Chigai Pharmaceutical)
Shinji Hatakeyama (JPMA)
Naoko Matsui (Daiichi Sankyo)
4. SOP (short lecture) Naoko Matsui (Daiichi Sankyo)
5. Wrap Up Shinji Hatakeyama (JPMA)
18:00-20:30 DINNER



2016 APEC Good Registration Management (GRM) regulatory Science Center of Excellence Pilot Workshop Draft Program

DAY 3 |17 NOVEMBER

Applicant-Specific Sessions
Time Topics Speakers
08:30-09:00 REGISTRATION
Session A3. Effective communications - Focusing follow-up actions during review period/Practice: Case study of how to handle inquires
Chair: Maya Kumano (JPMA)
09:00-09:30
  • Introduction :to share session objective
  • Ice Braking Game :Recognize the importance of instruction and communication
  • GRP Communication introduction: Explain effective communication Outline
Maya Kumano (JPMA)
09:30-10:30
  • Group Discussion: Recognize to communicate effectively with stakeholders under considerations of each stakeholders’ roles/responsibilities and gaps between the applicant and stakeholders
    • Lecture 1: Explain effective communication 1
      • Understand how to communicate with internal stakeholders /external stakeholders
      • Key points to be considered for communication with stakeholders
Kenichi Otani (Sumimoto Dainippon Pharma)
10:40-12:15
  • Practice : Find the practical effective communication with the stakeholder
  • Lecture 2: Explain effective communication 2
    • The points to consider in inquiries/responses and meetings with the review authorities during review period
    • The points that applicants have to consider in the management of the timeline for response preparation
  • Conclusion
Akiko Ikeda (Janssen Pharma K.K)
12:00-13:00LUNCHEON
Session A4: Rolling out the GRM training program in each economy
Chair: Isao Sasaki (JPMA)

13:15-14:45

Trainer’s Manual on GSubP: To provide instructions for the Trainer on how to organize and manage a GSubP training workshop in each economy Isao Sasaki (JPMA)
  • Facilitating team-based learning
  • 1. Fundamentals of a learning experience
    • Operationalizing Bloom’s Taxonomy for Learning
    • Meeting needs of working professionals in regulatory affairs
  • 2. Concepts of team-based learning
    • Pillars of team-based learning
    • Role of facilitators
  • 3. Using case examples for facilitated discussion
    • Developing case examples and the common errors
    • Conducting a team-based learning event
  • 4. Role-play
    • What happens in a facilitated discussion using case examples (participants will be divided into smaller teams)
Silke Vogel (CoRE)
James Leong (CoRE)
14:45-15:00REFRESHMENT BREAK
All participants
Session A5/R6. Panel discussion
Chair: Silke Vogel (CoRE)
15:00-15:15 RAPS Regulatory Competency FrameworkDiana Ryder Kaminsky (RAPS)
15:15-15:30
  • Competency gaps identified in Asia
    • Collated findings from workshops and ADB project
    • Outcomes from market analysis
Silke Vogel (CoRE)
15:30-16:30
  • Panel Discussion
    • Core competencies for industry and regulatory authorities
    • Priority competency areas to be addressed by 2020 (APEC roadmap timeline)
    • Objective measures of competencies
Panelists

Jinjie Hu (FDAAA/Biologics Consulting Group)
Chao-Yi Wang (TFDA)
Churn-Shiouh Gau (CDE)
Kanako Takatsuki (PMDA)
Lahouari Belgharbi (COFEPRIS)
Sannie Chong (Roche)
Christine Kuang (Boehringer Ingelheim)
Isao Sasaki (JPMA)
16:30-17:00 Q&A
17:00-17:10 CLOSING REMARKS Shiow-Ing Wu (TFDA)
Junko Sato (PMDA)



2016 APEC Good Registration Management (GRM) regulatory Science Center of Excellence Pilot Workshop Draft Program

DAY 2 |16 NOVEMBER

Reviewer-Specific Sessions
Time Topics Speakers
09:00-09:45 REGISTRATION
Session R1 : Managing the review
Chair: Chao-Yi Wang (TFDA)
09:30-09:45
  • 1. Session Purpose and Objectives
  • 2. Introductory icebreakers: Introduce yourself and briefly describe your expectation from the workshop
Chao-Yi Wang (TFDA)
09:45:10:00 3. An Introductory Overview of Managing the Review Based on the WHO Good Review Practice Guidelines for Regulatory Authorities Hsien-Yi Lin (TFDA)
10:00-10:40 4. Experience Sharing from Different Regulatory Authorities:
  • (1) Project management and Standard Operation in Drug Review
  • (2) How regulatory authorities conduct project management, etc. in managing the review ?PMDA’s experience
Zing Zhang (FDAAA/Janssen)
Kanako Takatsuki (PMDA)
10:40-10:50REFRESHMENT BREAK
10:50-11:10 4. Experience Sharing from Different Regulatory Authorities:(continued)
  • (3) Managing the Review in TFDA/CDE
  • (4) Q&A
Tai-Hsin Ou (CDE)
11:10-12:00
  • 5. Group Discussion
    • Trainees are divided into 4 discussion groups.
    • Facilitators participate in each discussion group.
  • Discussion Topics
    • (1) What are the current practices in managing the review among different economies?
    • (2) What are the challenges in managing the review among different economies?
    • (3) What are the gaps in managing the review among different economies?
    • (4) How to effectively utilize project management, quality management, standard operating procedures, and review process stages in managing the review?
  • 6. Briefing: Present the current practices, challenges and gaps in managing the review. Outline points to consider for effectively managing the review (by representatives of the 4 discussion groups)
  • 7. Wrap up and Q&A
Tai-Hsin Ou (CDE)
Chao-Yi Wang (TFDA)
Facilitators
Jing Zhang (FDAAA/Janssen)
Kanako Takatsuki (PMDA)
Tai-Hsin Ou (CDE)
Yu-Ting Chiu (CDE)
Hsien-Yi Lin (TFDA)
12:00-14:00LUNCHEON
Session R2. Communication: Fundamentals and case studies
Chair: Min Chen (FDAAA/TFDA)
14:00-16:00
  • Overview of the Fundamentals
Min Chen (FDAAA/TFDA)
Practices in Japan- Kanako Takatsuki (PMDA)
Case Studies- Florence Houn (FDAAA/Celgene)
Q&A
16:00-16:15 DINNER
18:00-20:30 DINNER



2016 APEC Good Registration Management (GRM) regulatory Science Center of Excellence Pilot Workshop Draft Program

DAY 3 |17 NOVEMBER

Reviewer-Specific Sessions
Time Topics Speakers
08:30-09:00 REGISTRATION
Session R3: Review personnel ? Critical thinking
Chair: Zing Zhang (FDAAA/Janssen)
09:00-10:30 Review personnel - Critical thinking Zing Zhang (FDAAA/Janssen)
  • Critical thinking and regulatory decision making: clinical reviewer’s perspectives
      • Critical Thinking
      • Different point of views
      • Regulatory Decision Making
      • Objectives
      • Efficacy Review: General Considerations
      • Case study
Yen-Wen Lin (CDE)
Panel Discussion Panelists
Zing Zhang (FDAAA/Janssen)
Florence Houn (FDAAA/Celgene)
Mark Goldberger (FDAAA)
Yen - Wen Lin (CDE)
10:30-10:45 REFRESHMENT BREAK
Session R4: Conducting the review
Chair: Junko Sato (PMDA)

10:45-12:15

  • Conducting the review
    • Explain the importance of covering the key point for the efficient review in the limitation of resources, and the points to be considered for a good review
Junko Sato (PMDA)
  • Conducting the review from pharmacokinetic reviewer’s perspectives
    • Filing and reviewing
    • Priority review and risk management
    • Introduction of PK’s review points
    • Case study
Yi-Lin Wang (CDE)
12:15-13:15LUNCHEON
Session R5. Rolling out the GRM training program in each economy
Chair: Jinjie Hu (FDAAA/Biologics Consulting Group)
13:15-14:45
  • 1. Introduction of RAPS Trainer’s Manual
  • 2. Build Good Review Practice into the Training Program
    • How to establish training program for different economies?
    • How to achieve managed review through an effective training program
Jinjie Hu (FDAAA/Biologics Consulting Group)
David T.Lin (FDAAA/Biologics Consulting Group)
  • 1. Training Curriculum Development
  • 2. Training Material Organization
    • Elements of CMC reviewer training curriculum
    • Sharing of CMC reviewer training experience
14:45-15:00REFRESHMENT BREAK
All participants
Session A5/R6. Panel discussion
Chair: Silke Vogel (CoRE)
15:00-15:15 RAPS Regulatory Competency FrameworkDiana Ryder Kaminsky (RAPS)
15:15-15:30
  • Competency gaps identified in Asia
    • Collated findings from workshops and ADB project
    • Outcomes from market analysis
Silke Vogel (CoRE)
15:30-16:30
  • Panel Discussion
    • Core competencies for industry and regulatory authorities
    • Priority competency areas to be addressed by 2020 (APEC roadmap timeline)
    • Objective measures of competencies
Panelists

Jinjie Hu (FDAAA/Biologics Consulting Group)
Chao-Yi Wang (TFDA)
Churn-Shiouh Gau (CDE)
Kanako Takatsuki (PMDA)
Lahouari Belgharbi (COFEPRIS)
Sannie Chong (Roche)
Christine Kuang (Boehringer Ingelheim)
Isao Sasaki (JPMA)
16:30-17:00 Q&A
17:00-17:10 CLOSING REMARKS Shiow-Ing Wu (TFDA)
Junko Sato (PMDA)