About workshop

Venue & Schedule

The workshop will be held virtually by

Part 1¡GOnline Self-Learning Lectures / August 24 - September 16

Part 2¡GLive Videoconferences / September 14 - September16

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

 

Co-organizers
The APEC LSIF Regulatory Harmonization Steering Committee


Pharmaceuticals and Medical Devices Agency, Japan

 

Asia Partnership Conference of Pharmaceutical Associations

workshop NEWS

TFDA convenes the 2021 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 (2021), despite the drastic impact that COVID-19 pandemic has brought to the globe and people around the world, in order to keep promoting the concept of GRM and cultivate regulatory professionals, TFDA still manages to convene the ‘2021 APEC GRM CoE Workshop’. Due to the travel restrictions, the workshop will be held virtually (on-line) with 2 parts. In Part 1 (August 24th to September 16th), there will be pre-recorded, self-learning lectures on the APEC GRM CoE Website. And in part 2 (September 14th to 16th), there will be live videoconferences 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 two sessions that focus on topics of special interests, like ‘Regulatory Challenges of COVID-19’ and ‘The application of RWD/RWE in regulatory decision-making’. 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: Self-Learning Lecture (Pre-recorded) from August 24th–September 16th

  TOPICS TIME SPEAKER
Content 1 Opening Remarks 10 Mins

Shih-Chung Chen

Minister, Ministry of Health and Welfare

MOHW

Shou-Mei Wu

Director General

Taiwan Food and Drug Administration

TFDA

GRM Core-Curriculum Sessions
Session 1 Introduction of GRM
¡EConcept of GRM
¡EAchievements of APEC Roadmap to Promote GRM in the past decade
¡EObjective of the training
20 Mins

Chyn-Liang (Cindy) Huang

Senior Technical Specialist

Division of Medicinal Products

Taiwan Food and Drug Administration

TFDA

Session 2 Planning of Application
¡EPlanning of New Drug Application
¡EPlanning of Generic Drug Application
40 Mins

Finny Liu

APAC Regional Regulatory Policy Lead

Roche Singapore

Jocelyn Lee

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

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

Kumiko Hikida

Manager

Global Regulatory Affairs Department

Mitsubishi Tanabe Pharma Cooperation  

APAC

Hiroko Kawaguchi

Prin. Scientist
Regulatory Affairs Area

MSD. K. K

APAC

Session 4 Managing and Conducting the Review
¡EAn Introductory Overview of Managing the Review Based on the WHO GRevP Guidelines for Regulatory Authorities
20 Mins

Shu-Ping Huang

Technical Specialist
Division of Medicinal Products

Taiwan Food and Drug Administration

TFDA

Session 5

Bringing Consistency and Efficiency to Regulatory Decision-Making

¡EGuidelines provide the building blocks for the construction of a fit-for-purpose dossier

¡ECommunicating the agency’s expectations for the dossier- pre-submission advice

¡ECommunicating the agency’s assessment decision


30 Mins

Lawrence Liberti

Adjunct Research Professor
Reg Affairs and Quality Assurance

Graduate Program
Temple University School of Pharmacy
Session 6

Communication

  1. (1) Overview of Communication mechanisms – Review authorities’ Aspects
    • ¡ECommunication cycle management
    • ¡ETiming of Communication
    • ¡ECommunication pathways
(2) Overview of Communication mechanisms- Industry Aspects
20 Mins

(Regulator’s Aspect)
Yu-Ju Lin

Project Manager

Center for Drug Evaluation

CDE

(Industry’s Aspect)
Shinji Hatakeyama

Leader

Regulations and Approvals Expert Working Group

APAC

Topic of Special Interest I: Promoting Regulatory Cooperation
Session 7 Promoting Regulatory Efficiencies and Public Health through Cooperation in Review Process(Tentative)
¡EIntroduction and updated outcomes from ACCESS Consortium.
¡E
The positive impacts of reliance and cooperation in promoting regulatory efficiencies
30 Mins

Michael Shum

Director

Application and Advisory Management
Prescription Medicines Authorisation Branch
Medicines Regulation Division
Health Products Regulation Group
Australian Government Department of Health

Topic of Special Interest II: The Application of RWD/RWE in Regulatory Decision-Making
Session 8

Considerations of the Application of RWD/RWE in Regulatory Decision-Making

    • ¡EIntroduction of RWD/RWE
    • ¡EExamples
    • ¡ERegulatory Perspective

 

20 Mins

Chi-Hsun Chen

Senior Clinical Section Chief

Center for Drug Evaluation

CDE

 

 

 

PART 2: Live Videoconference (via Webex)

DAY 1: September 14th, 14h00-16h30 ( GMT+8 Time )

TOPIC TIME SPEAKER
Group Discussion I: Case Study- Planning of Submission and Preparation of Application Dossier
Overview of the session 1400-1410

Rosa Fu

Associate Director Regulatory Affairs

Eli Lilly and Company

IRPMA

Discussion on generic drugs & new drugs

1410-1510

Finny Liu

APAC Regional Regulatory Policy Lead
Roche Singapore

Jocelyn Lee

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

Break Time 1510-1525
Group Presentation 1525-1615
(TBD)

Finny Liu

APAC Regional Regulatory Policy Lead

Roche Singapore

Jocelyn Lee

Senior Regulatory Manager
Project & Regulatory Affairs Division

TTY Biopharm Co., Ltd.

Wrap Up and Take Home Messages 1615-1630

Rosa Fu

Associate Director Regulatory Affairs

Eli Lilly and Company

IRPMA

Finny Liu

APAC Regional Regulatory Policy Lead

Roche Singapore

Jocelyn Lee

Senior Regulatory Manager
Project & Regulatory Affairs Division

TTY Biopharm Co., Ltd.

 

 

DAY 2: September 15th ,14h00-16h30 ( GMT+8 Time )

TOPIC TIME SPEAKER
Group Discussion II: Case Study: Managing and Conducting the Review
Overview of the session
1400-1410

Chi-Hsun Chen

Senior Clinical Section Chief
Center for Drug Evaluation

CDE
Group Discussion (Tentative) 1410-1510 TBD
Break Time 1510-1525
Group Presentation 1525-1615
(TBD)

Chi-Hsun Chen

Senior Clinical Section Chief

Center for Drug Evaluation

CDE

Wrap Up and Take Home Message 1615-1630

Chi-Hsun Chen

Senior Clinical Section Chief

Center for Drug Evaluation

CDE

 

 

DAY 3: September 16th ,14h00-16h00 ( GMT+8 Time )

TOPIC TIME SPEAKER
1st Videoconference
Brief Opening 1400-1410

Shou-Mei Wu

Director General

Taiwan Food and Drug Administration

TFDA

Regulatory Challenges Against
COVID-19: Experience Sharing of TFDA
1410-1430

Shou-Mei Wu

Director General

Taiwan Food and Drug Administration

TFDA

International Collaboration in time of COVID-19: the Need for Regulatory agility

1430-1500

Agnès Saint-Raymond

Head of Division International Affairs
EMA

Regulatory Challenges against
COVID-19: Experience Sharing of Japan
1500-1520

Yuriko Takemura

Coordinator

Division of Asia II

Office of International Programs

PMDA

Break Time 1520-1535
2nd Videoconference

Expectations from the workshop

1535-1550

Daisuke Koga

Division Director

Division of Asia II

Office of International Programs

PMDA

Shinji Hatakeyama

Leader

Regulations and Approvals Expert Working Group

APAC

Ping-Chiang Lyu

Chairman

RAPS Taiwan Chapter

Closing Remarks + Virtual Photo Time 1550-1600

Shou-Mei Wu

Director General

Taiwan Food and Drug Administration

TFDA

 

¡¯ The program may be subjected to change.

 

ONLINE SELF-LEARNING LECTURE






WORKSHOP REGISTRATION

Workshop Registration



Note
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

Email¡GGRMCOE@gmail.com

Tel¡G+886-3-5623128