About workshop

Venue & Schedule

The workshop will be held virtually by

Part 1:Online Self-Learning Lecture (Pre-recorded) / August 29 - September 11

Part 2:Webinar / 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

 

Co-organizers
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

  TOPICS TIME SPEAKER
Content 1 Welcome Letter N/A

Shou-Mei Wu

Director General

Taiwan Food and Drug Administration (TFDA)
Session 1 Introduction of GRM
•Concept of GRM
•Achievements of APEC Roadmap to promote GRM
•Objectives of this year's workshop
20 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
•Planning of Generic Drug Application & Example of Registration
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
Standard process of application dossier preparation
•Support tools (template, glossary, checklist & timeline table)
20 Mins

Kumiko Hikida

Manager

Global Regulatory Affairs Department

Mitsubishi Tanabe Pharma Cooperation  

APAC

Session 4

Managing and Conducting the Review
•An introductory overview of managing the review

•Example of implementing GRevP in the review process

15 Mins

Wan-Yu Chao

Specialist
Division of Medicinal Products

Taiwan Food and Drug Administration (TFDA)
Session 5

Using Facilitated Regulatory Pathways (FRPs) for Special Case Authorizations

  • •Understanding FRP and work sharing models as they apply to special authorizations
  • •Practical cases: How these pathways have been used for
    •   -COVID-19 authorizations
    •   -Orphan Drugs
    •   -Advanced Therapeutic Medicinal products
  • •Barriers and promotors
30 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

  • •Effective Communication
  • •Communication with Applicants in Taiwan
  • •Case Scenario-Consultation
10 Mins

Ting-Yao Wang

Project Manager
Division of Regulatory Affairs and Compliance

Center for Drug Evaluation
Communication ~Industries’ Aspects~
•Sharing importance of effective communication based on APEC RHSC Good Submission Practice Guideline for Applicants
10 Mins

Shinji Hatakeyama

Leader
Regulations and Approvals Expert Working Group (RA-EWG)

APAC
Topic of Special Interest I: Orphan Drug Regulations
Session 7 Review Consideration of Orphan Drugs- Taiwan's Perspective
20 Mins

Yen-Hui Wu

Deputy Director
Division of New Drugs

Center for Drug Evaluation
An Overview of the European Orphan Regulation
  • •Procedure for orphan designation
  • •Marketing authorisations of orphan drugs
  • •International Collaboration
  • •Tips and tricks (i.e., lessons learned over the years)
20 Mins Kristina Larsson

Head of Orphan Medicines
Division of Human Medicines Evidence Generation

EMA
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

 

20 Mins

Atsushi Noguchi

Deputy Review Director
Office of New Drug V

PMDA

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

 

20 Mins

Alexander Liede

Senior Director

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

Abbvie

 

 

 

PART 2: Webinar

DAY 1: September 13th, 14h00-16h50 ( GMT+8 Time )

TOPIC TIME SPEAKER
Group Discussion 1: Case Study: Planning of Submission and Preparation of Application Dossier
Overview on Generic drugs & New Drugs cases 10 Mins

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

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

Facilitator
 IRPMA & TFDA/CDE Members

Discussion on generic drugs & new drugs (7 groups)

60 Mins
Break Time 10 Mins
Group Presentation (7 groups, around 8 mins/group) 60 Mins
Q&A 15 Mins
Wrap Up and Take Home Messages 15 Mins

 

 

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

TOPIC TIME SPEAKER
Group Discussion II: Review of Biosimilar Products: Basic Principles
Overview of the session
10 Mins

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

Speaker
 Participants

Facilitator

 TFDA/CDE Members
Case discussions (7 groups) 60 Mins
Presentations (7 groups, around 8 mins/group) 60 Mins
Break Time 10 Mins
Q & A 10 Mins
Wrap Up and Take Home Message 10 Mins

 

 

DAY 3: September 15th ,08h30-11h00 ( GMT+8 Time )

TOPIC TIME SPEAKER
Brief Opening + Virtual Photo Time 08h30-08h40

Shou-Mei Wu
Director General

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

Jo-Feng Chi
Researcher
Division of Medicinal Products

Taiwan Food and Drug Administration
(TFDA)

Key components of a vaccine safety program in the evolving COVID-19 vaccine campaign

08h50-09h15

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

Moderna
Q & A Time 09h15-09h20
ACCESS Work-sharing Model (TBD) 09h20-09h45

John Skerritt
Adjunct Professor
Deputy Secretary for Health Products Regulation
Department of Health

Australia
Q & A Time 09h45-09h50

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

  • •Provide an overview of FDA pilot programs
  • •Share BMS learnings on FDA pilots of Project Orbis, RTOR, Assessment Aid
  • •Offer insight on considerations needed when submissions occur via these innovative processes

 

09h50-10h15

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

BMS
Q & A Time 10h15-10h20
Gulf Health Coucnil's experience in Reliance (TBD) 10h20-10h45

Hajed M. bin Hajed

Deputy General Manager
Deputy General Manager Office of Gulf
Health Council
Q & A Time 10h45-10h50
Closing Remarks+ Virtual Photo Time 10h50-11h00

Shou-Mei Wu
Director General

Taiwan Food and Drug Administration
(TFDA)

 

* The program may be subjected to change.

 

ONLINE SELF-LEARNING LECTURE

ONLINE SELF-LEARNING LECTURE

ONLINE SELF-LEARNING LECTURE

Instruction for 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

EmailGRMCOE@gmail.com

Tel:+886-3-5623128