About workshop

Venue & Schedule

The workshop will be held virtually by

Part 1¡GOnline Self-Learning Lecture (Pre-recorded) / August 29 - September 11

Part 2¡GWebinar / September 13 - September 15

Target Audience

1. Regulatory professionals from authorities with at least one to three years of hands-on experience in the management of regulatory reviews.
2. Regulatory professionals from industries with at least one to three years of hands-on experience in the management of regulatory submissions.
3. Academia who are interested in learning GRevP or GSubP guidelines.
4. Professional bodies who are actively involved in training.

CoE Hosting Institutions
Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW)


Regulatory Affairs Professionals Society RAPS Taiwan Chapter


The APEC Regulatory Harmonization Steering Committee

Pharmaceuticals and Medical Devices Agency, Japan


Asia Partnership Conference of Pharmaceutical Associations

workshop NEWS

TFDA convenes the 2022 APEC GRM CoE Workshop

Taiwan Food and Drug Administration (TFDA) has been engaging in the APEC LSIF-RHSC to promote the concept of Good Registration Management (GRM). In 2017, TFDA and RAPS Taiwan Chapter were formally endorsed as the co-host institutions of the APEC GRM Regulatory Science Center of Excellence (CoE). From then on, the CoE co-host institutions has annually convened training activities to achieve the goal of promoting GRM (which includes Good Review Practice and Good Submission Practice), international cooperation and capacity building among APEC economies.

This year (2022), TFDA continue to host the ‘2022 APEC GRM CoE Workshop’. The workshop will be held virtually (on-line) with 2 parts. In Part 1 (August 29th to September 11th), there will be pre-recorded, self-learning lectures on the APEC GRM CoE Website. And in part 2 (September 13th to 15th), there will be live webinar for group and panel discussions. The Co-host institutions of GRM CoE have designed the program based on the APEC GRM Core Curriculum. In addition, there will be three sessions that focus on topics of special interests, like ‘Orphan Drug Regulations’, ‘RWD/RWE for regulatory decision-making’ and ‘Review collaboration experience sharing from RA and industry perspectives’. For more details, please refer to the ‘WORKSHOP AGENDA’ section of this web page.

The target participants of this workshop include regulators from the authority, applicants from the industries, and researchers in academia who are interested in the GRM of medicinal products. We look forward to your participation and please register for the workshop on the page of ‘WORKSHOP REGISTRATION’. Thank you.

  • Tracy

workshop agenda

PART 1: Online Self-Learning Lecture (Pre-recorded) from August 29th to September 11th

Content 1 Welcome Letter N/A

Shou-Mei Wu

Director General

Taiwan Food and Drug Administration (TFDA)
Session 1 Introduction of GRM
¡EConcept of GRM
¡EAchievements of APEC Roadmap to promote GRM
¡EObjectives of this year's workshop
17 Mins

Chia-Ping Liu

Section Chief
Division of Medicinal Products

Taiwan Food and Drug Administration (TFDA)
Session 2 Planning of Application
Planning of New Drug Application & Example of Registration
¡EPlanning of Generic Drug Application & Example of Registration
30 Mins

Finny Liu

APAC Regional Regulatory Policy Lead

Roche Singapore
33 Mins

Jocelyn Lee

Senior Regulatory Manager
Project & Regulatory Affairs Division
TTY Biopharm Co., Ltd

Session 3 Preparation of Application Dossier
Standard process of application dossier preparation
¡ESupport tools (template, glossary, checklist & timeline table)
23 Mins

Kumiko Hikida


Global Regulatory Affairs Department

Mitsubishi Tanabe Pharma Corporation  


Session 4

Managing and Conducting the Review
¡EAn introductory overview of managing the review

¡EExample of implementing GRevP in the review process

20 Mins

Wan-Yu Chao

Division of Medicinal Products

Taiwan Food and Drug Administration (TFDA)
Session 5

Using Facilitated Regulatory Pathways (FRPs) for Special Case Authorizations

  • ¡EUnderstanding FRP and work sharing models as they apply to special authorizations
  • ¡EPractical cases: How these pathways have been used for
    • ¡@¡@-COVID-19 authorizations
    • ¡@¡@-Orphan Drugs
    • ¡@¡@-Advanced Therapeutic Medicinal products
  • ¡EBarriers and promotors
50 Mins

Lawrence Liberti

Adjunct Research Professor
Reg Affairs and Quality Assurance Graduate Program
Temple University School of Pharmacy

Session 6

Communication with Applicants-Regulator’s Aspects

  • ¡EEffective Communication
  • ¡ECommunication with Applicants in Taiwan
  • ¡ECase Scenario-Consultation
10 Mins

Ting-Yao Wang

Project Manager
Division of Regulatory Affairs and Compliance

Center for Drug Evaluation
Communication ~Industries¡¦ Aspects~
¡ESharing importance of effective communication based on APEC RHSC Good Submission Practice Guideline for Applicants
10 Mins

Shinji Hatakeyama

Regulations and Approvals Expert Working Group (RA-EWG)

Topic of Special Interest I: Orphan Drug Regulations
Session 7 Regulatory Perspective of Orphan Drug Development for Rare Diseases
12 Mins

Yen-Hui Wu

Deputy Director
Division of New Drugs

Center for Drug Evaluation
An Overview of the European Orphan Regulation
  • ¡EProcedure for orphan designation
  • ¡EMarketing authorisations of orphan drugs
  • ¡EInternational Collaboration
  • ¡ETips and tricks (i.e., lessons learned over the years)
28 Mins Kristina Larsson

Head of Office
Orphan Medicines
Human Medicines

Topic of Special Interest II: RWD/RWE for regulatory decision-making
Session 8

The Challenges of the application of RWD/RWE in regulatory decision making from PMDA’s perspective


18 Mins

Atsushi Noguchi

Deputy Review Director
Office of New Drug V


Evolving Role of Real-Word Data (RWD) & Evidence (RWE) in Drug Development


30 Mins

Alexander Liede

Senior Director

Head of Evidence and Partnerships
Global Epidemiology, Pharmacovigilance and Patient Safety (PPS)





PART 2: Webinar

DAY 1: September 13th, 14h00-17h00 ( GMT+8 Time )

Group Discussion 1: Case Study: Planning of Submission and Preparation of Application Dossier
Overview on New Drugs & Generic Drugs Cases 14h00-14h15

 Rosa Fu
 Associate Director
 Regulatory Affairs
 Eli Lilly and Company (Taiwan)

 Finny Liu
 APAC Regional Regulatory Policy
 Roche Singapore
 Jocelyn Lee
 Senior Regulatory Manager
 Project & Regulatory Affairs Division
 TTY Biopharm Co., Ltd.


Discussion on New Drugs & Generic Drugs Cases (4 groups of New Drugs/ 3 groups of Generic Drugs)

Break Time 15h15-15h25
Group Presentation I (4 groups of New Drugs, around 8 mins/group) 15h25-16h10
Group Presentation II (3 groups of Generic Drugs, around 8 mins/group) 16h10-16h50
Q&A / Wrap Up 16h50-17h00



DAY 2: September 14th ,14h00-16h40 ( GMT+8 Time )

Group Discussion II: Review of Biosimilar Products: Basic Principles
Overview of the session

 Chi-Hsun Chen
 Senior Clinical Section Chief
 Center for Drug Evaluation

 Chi-Hsun Chen

Chia-Hsun Tsai (½²¨Î¬¬)
Jun-Fon Wang (¤ýµ¤¾W)

Case discussions (7 groups) 14h10-15h10
Presentations (Groups A to C, around 8 mins/group), 3 groups 15h10-15h35
Break Time 15h35-15h45
Presentations (Groups D to G, around 8 mins/group), 4 groups 15h45-16h20
Q & A 16h20-16h30
Wrap Up & Take Home Messages 16h30-16h40



DAY 3: September 15th ,08h30-11h10 ( GMT+8 Time )

Brief Opening 08h30-08h40

Shou-Mei Wu
Director General

Taiwan Food and Drug Administration
COVID-19 Vaccine Pharmacovigilance: TFDA’s experience 08h40-08h50

Jo-Feng Chi
Division of Medicinal Products

Taiwan Food and Drug Administration

Modular study design within a vaccine safety program


Daina Esposito
Senior Director, Global Safety Epidemiologist
Clinical Safety and Risk Management

Q & A Time 09h15-09h20

US FDA Pilots: Project Orbis, Real Time Oncology Review (RTOR), Assessment Aid
- BMS’s Experience

  • ¡EProvide an overview of FDA pilot programs
  • ¡EShare BMS learnings on FDA pilots of Project Orbis, RTOR, Assessment Aid
  • ¡EOffer insight on considerations needed when submissions occur via these innovative processes


09h20- 09h45

Heidi Wang
Vice President
Head of Oncology
Global Regulatory Strategy & Policy

Q & A Time 09h45-09h50
Virtual Photo Time (With All Speakers and Guests) 09h50-09h55  
ACCESS Work-sharing model 09h55- 10h20

John Skerritt
Adjunct Professor
Deputy Secretary for Health Products Regulation
Australian Department of Health and Aged Care

Q & A Time 10h20- 10h25

Gulf Health Council, experience in Reliance

10h25- 10h50

Hajed M. H. Hashan
Deputy of General Manager

Gulf Health Council
Brief Announcement 10h50- 10h55  

Closing Remarks I


Junko Sato
Office Director
Office of International Program

Pharmaceuticals and Medical Devices Agency (PMDA)
Closing Remarks II 11h00-11h05

Shinji Hatakeyama
Regulations and Approvals Expert Working Group (RA-EWG)

Asia Partnership Conference of Pharmaceutical Associations (APAC)
Closing Remarks III+ Virtual Photo Time (With All Participants) 11h05-11h10

Shou-Mei Wu
Director General

Taiwan Food and Drug Administration (TFDA)


¡¯ The program may be subjected to change.





Instruction for Online Self-Learning Lecture


Workshop Registration

1. Registration fee is not required for participating in the workshop.
2. Because of the limited number for workshop participants, the background and qualification of candidates who have completed the registration process will be reviewed by the GRM CoE Co-Host Institutions, and the accepted candidates will be informed soon after the registration deadline.

Certificate Requirements

The electronic certificate of participation will be provided to the qualified trainees who have met the requirements listed as follows:

1. The completion of 80% of Self-Learning Lectures by hours.
2. The attendance of all 3 Live Videoconferences.
3. The completion of all questionnaires.


If you have any question or suggestion, please do not hesitate to contact the GRM CoE Secretariat. Thank you