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About workshop

Venue & Schedule

Date: September 3-5, 2024 

Venue for Workshop Day 1 & Day 3:National Biotechnology Research Park, Building C, Room  C201

Venue for Workshop Day 2:COURTYARD by Marriott  Taipei        

Target Audience

1. Regulatory professionals from authorities with hands-on experience in the management of regulatory reviews.
2. Regulatory professionals from industries with 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 Institution
Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW)

 

 

 

 

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 2024 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 was formally endorsed as the host institution of the APEC GRM Regulatory Science Center of Excellence (CoE). From then on, the CoE host institution 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 (2024), TFDA continue to host the ‘2024 APEC GRM CoE Workshop’. The workshop will be held in Chinese Taipei. The host institution of GRM CoE have designed the program based on the APEC GRM Core Curriculum. In addition, there will be sessions that focus on topics about best practices on  ‘Benefit-Risk Assessment in Regulatory Decision-Making for Market Authorization of Medicinal Products’. 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

Day 1:   Tuesday, September 3, 2024

 

 

Day 2:   Wednesday, September 4, 2024

 

Day 3:   Thursday, September 5, 2024

 

 



 

 

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 Host Institution, 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 attendance of all 3 days of workshop sessions.
2. The completion of all questionnaires.
 




 

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

EmailGRMCOE@gmail.com

Tel:+886-3-5623116 EXT. 3651