1. Is this workshop free?
Yes. There is no registration fee for the workshop
2. Is it possible to extend it to regulators in other countries?
Yes.
We welcome regulators from APEC member economies and non-APEC member economies. Please provide their emails to
TFDAMDCOE@GMAIL.COM . We will send information to them.
3. What do I need to prepare for the workshop?
- Please download and read the guidances from TFDA CoE website at https://tfdamdcoe.itri.org.tw/training.html These guidances are training materials for the workshop.
- We will request one participant from each regulatory authority to introduce the medical device regulation of its country in the first videoconference. The PowerPoint template will be sent out in early August and we expect to receive the presentation slides on August 21.
- The practice of EP table will be open for participants from August 29 to September 7. Please remember to do the assignment and interact with other group members.
4. How many people could register for the workshop from one organization?
We expect at most 2 to 3 participants from one organization, and in total 40-60 participants for the workshop. However, the number of participants is limited. Priority will be considered to regulators. The selection of workshop participants will be made after the registration closing date on August 12. The confirmation letter will be sent out on August 17.
5. How could I register for the workshop?
6. If I could not attend 2nd and 3rd videoconferences for case studies, could I register for the workshop?
No. The case study is the most important part of the workshop. If you already know you are unable to attend the videoconferences on September 8th or September 9th, we would recommend you to give the opportunity to other potential participants.
7. Should I participate in the information meeting for enrollment, so that I can participate in the workshop?
No. It is not necessary to participate in the information meeting before the workshop. People who do not attend the information meeting can still register for the workshop.
8. If I can not attend the videoconference, can I watch the recorded video of the videoconference?
No. The purposes of the videoconferences are for group discussion and thought expression. We would recommend you to join the discussion rather than watch the video afterward.