About workshop

The workshop will be held virtually by

Part 1：Online Self-Learning Lectures / August 24 - September 16

Part 2：Live Videoconferences / September 14 - September16

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.

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

Regulatory Affairs Professionals Society RAPS Taiwan Chapter

The APEC LSIF Regulatory Harmonization Steering Committee

Pharmaceuticals and Medical Devices Agency, Japan

Asia Partnership Conference of Pharmaceutical Associations

workshop NEWS

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.

workshop agenda

Open from from August 24^th 09h00 to September 16^th 24h00 (GMT+8 Time)

	TOPICS	TIME	SPEAKER
Content 1	Opening Remarks	5 Mins	Shih-Chung Chen Minister, Ministry of Health and Welfare MOHW
Content 1	Opening Remarks	5 Mins	Shou-Mei Wu Director General Taiwan Food and Drug Administration TFDA
GRM Core-Curriculum Sessions
Session 1	Introduction of GRM ‧Concept of GRM ‧Achievements of APEC Roadmap to Promote GRM in the past decade ‧Objective of the training	30 Mins	Chyn-Liang (Cindy) Huang Senior Technical Specialist Division of Medicinal Products Taiwan Food and Drug Administration TFDA
Session 2	Planning of Application ‧Planning of New Drug Application ‧Planning of Generic Drug Application	50 Mins	Finny Liu APAC Regional Regulatory Policy Lead Roche Singapore
Session 2		50 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 ‧Support tools (template, glossary, checklist & timeline table)	25 Mins	Kumiko Hikida Manager Global Regulatory Affairs Department Mitsubishi Tanabe Pharma Cooperation APAC
Session 3		25 Mins	Hiroko Kawaguchi Prin. Scientist Regulatory Affairs Area MSD. K. K APAC
Session 4	Managing and Conducting the Review ‧An 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 ‧Guidelines provide the building blocks for the construction of a fit-for-purpose dossier ‧Communicating the agency’s expectations for the dossier- pre-submission advice ‧Communicating the agency’s assessment decision	25 Mins	Lawrence Liberti Adjunct Research Professor Reg Affairs and Quality Assurance Graduate Program Temple University School of Pharmacy
Session 6	Communication (1) Overview of Communication mechanisms – Review authorities’ Aspects ‧Communication cycle management ‧Timing of Communication ‧Communication pathways (2) Overview of Communication mechanisms- Industry Aspects	15 Mins	(Regulator’s Aspect) Yu-Ju Lin Project Manager Center for Drug Evaluation CDE
Session 6		15 Mins	(Industry’s Aspect) Shinji Hatakeyama Leader Regulations and Approvals Expert Working Group APAC
Topic of Special Interest I: Promoting Regulatory Cooperation
Session 7	The Access Consortium New Active Substance working-sharing procedure – An Australian perspective ‧Overview of TGA’s reliance pathways and principles-where does Access fit? ‧What is Access ‧Key features of the work-sharing procedure ‧TGA perspectives	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 ‧Introduction of RWD/RWE ‧Examples ‧Regulatory Perspective	15 Mins	Chi-Hsun Chen Senior Clinical Section Chief Center for Drug Evaluation CDE

DAY 1: September 14^th, 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 cases (7 groups)	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 (7 groups, around 8 min/group)	1525-1615	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 15^th ,14h00-17h05 ( GMT+8 Time )

TOPIC	TIME	SPEAKER
Group Discussion II: Case Study: Managing and Conducting the Review - Fixed Dose Combination Products
Overview of the session	1400-1410	Chi-Hsun Chen Senior Clinical Section Chief Center for Drug Evaluation CDE
Presentation by Each Economic (I) (6 economies, 8-15 min/economy)	1410-1520	Representatives of APEC member economies
Break Time	1520-1530
Presentation by Each Economic (II) (6 economies, 8-15 min/economy)	1530-1640	Representatives of APEC member economies
Break Time	1640-1650
Wrap Up and Take Home Message	1650-1705	Chi-Hsun Chen Senior Clinical Section Chief Center for Drug Evaluation CDE

DAY 3: September 16^th ,14h00-16h20 ( GMT+8 Time )

TOPIC	TIME	SPEAKER
1^st Videoconference
Brief Opening +Virtual Photo Time	1400-1410	Shou-Mei Wu Director General Taiwan Food and Drug Administration TFDA
Regulatory Measure in Response to COVID-19 in Taiwan	1410-1430	Shou-Mei Wu Director General Taiwan Food and Drug Administration TFDA
Brief Q&A Session	1430-1435
International Collaboration in time of COVID-19: the Need for Regulatory Agility	1435-1505	Agnès Saint-Raymond Head of Division International Affairs EMA
Brief Q&A Session	1505-1510
Regulatory Challenges Against COVID-19: Experience Sharing of Japan	1510-1530	Yuriko Takemura Coordinator Division of Asia II Office of International Programs PMDA
Brief Q&A Session	1530-1535
Break Time	1535-1550
2nd Videoconference
Expectations from the workshop	1550-1605	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 with all workshop participants	1605-1615	Shou-Mei Wu Director General Taiwan Food and Drug Administration TFDA

＊ The program may be subjected to change.

ONLINE SELF-LEARNING LECTURE

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.

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：GRMCOE@gmail.com

Tel：+886-3-5623128

About workshop

Venue & Schedule

Target Audience

CoE Hosting Institutions

Co-organizers

workshop NEWS

TFDA convenes the 2021 APEC GRM CoE Workshop

workshop agenda

PART 1: Self-Learning Lecture (Pre-recorded)

Open from from August 24^th 09h00 to September 16^th 24h00 (GMT+8 Time)

PART 2: Live Videoconference (via Webex)

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

DAY 2: September 15^th ,14h00-17h05 ( GMT+8 Time )

DAY 3: September 16^th ,14h00-16h20 ( GMT+8 Time )

ONLINE SELF-LEARNING LECTURE

ONLINE SELF-LEARNING LECTURE

WORKSHOP REGISTRATION

Workshop Registration

Note

Certificate Requirements

About workshop

Venue & Schedule

Target Audience

CoE Hosting Institutions

Co-organizers

workshop NEWS

TFDA convenes the 2021 APEC GRM CoE Workshop

workshop agenda

PART 1: Self-Learning Lecture (Pre-recorded)

Open from from August 24th 09h00 to September 16th 24h00 (GMT+8 Time)

PART 2: Live Videoconference (via Webex)

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

DAY 2: September 15th ,14h00-17h05 ( GMT+8 Time )

DAY 3: September 16th ,14h00-16h20 ( GMT+8 Time )

ONLINE SELF-LEARNING LECTURE

ONLINE SELF-LEARNING LECTURE

WORKSHOP REGISTRATION

Workshop Registration

Note

Certificate Requirements

Open from from August 24^th 09h00 to September 16^th 24h00 (GMT+8 Time)

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

DAY 2: September 15^th ,14h00-17h05 ( GMT+8 Time )

DAY 3: September 16^th ,14h00-16h20 ( GMT+8 Time )