| *Saving the Date for Preliminary session | Participants are obligated to join in the Preliminary Session from 2 pm to 3 pm, JST (5 am to 6 am, UTC) on Tuesday, January 10, to take full advantage of the Live sessions.
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| *Saving the Date for Live session | Participants are required to join all the seminar sessions from January 16 to 19, from 2 pm to 5 pm, JST (5 am to 8 am, UTC).
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| *Full name | Information entered here will be used for your certificate of participation and other lists
(First name, Family name)
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| *Male / Female | |
| *Title | |
Calling name
(Short name) | Please let us know your calling name or short name by which you prefer to be called casually during the webinar, especially in the group discussion.
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| *Job title | |
| *Department / Division | |
| *Organization | |
Organization
(other) | If you chose "Other" in the above, please describe here.
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| *Country | |
| Country (other) | If you chose "Other" in the above, please describe here.
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| *Attendee e-mail address | Please enter e-mail address that can be used for communications with the secretariat and contacted in an urgent situation.
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| *Attendee e-mail address (sub) | Please enter an alternative e-mail address for back up purpose.
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Any other e-mail address
(If necessary) | Other e-mail address you need to include in the communiations with the secreariat.
(supervisor,secretary, etc...)
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*Phone number
(Office) | |
*Phone number
(Mobile) | |
*Name and title of your supervisor
1) Name: | When you are chosen as the participant, an acceptance letter addressed to you and your supervisor will be provided, using the information entered here.
(e.g. “Dr. FUJIWARA Yasuhiro”: Make sure to include Mr. Ms. or Dr.)
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*Name and title of your supervisor
2) Title: | (e.g. “Chief Executive of PMDA”)
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| *Your expertise field | |
| *Experience level in your expertise field | |
| Other expertise field | If you chose "Other" in the above, please describe the details of your field.
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| *Years of experience as a Regulator | Please fill in years of experience as a Regulator.
years |
| *Your current regulatory appointments | Describe your current regulatory appointments as much detailed as possible.
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| *Your expectation | What specific issue you want to address in your work and what aspect you expect to learn from the seminar.
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| *E-learning course (MRCT) | As stated in the application webpage, all participants are required to complete the PMDA-ATC E-learning course "Multi-Regional Clinical Trial (MRCT)" before attending the webinar.
Please select one of the below.
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E-learning
application info | If you chose 1 or 2 in the above, please state your valid login ID or the date (yyyy/mm/dd) you have applied for the PMDA-ATC E-learning course.
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| *Declaration of application | 1. Please download the format from the following link; Signature form
2. Please print out the form and put you and your supervisor's signature on it.
3. Please upload the PDF file
→ link to Signature instruction |
| *Announcements from PMDA | *PMDA would like to send announcements regarding PMDA international activities (e.g., PMDA-ATC seminars, PMDA Updates) to your email address.
If you do NOT wish to receive these emails, please check the following box.
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PMDA would like you to submit the “Commitment Form” from the below to gain access to the webinar materials and attend the live sessions. Please read through each paragraph, enter necessary information and click "Agree"
Commitment Form
To: Chief Executive of the Pharmaceuticals and Medical Devices Agency
I hereby pledge that during the course of the webinar program (“Program”), I agree:
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| Clause 1 | To concentrate on the training activities and make best efforts to achieve the objectives of the Program.
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| Clause 2 | To comply with instructions by PMDA on confidentiality of information, and not reveal, plagiarize, abuse any person’s privacy nor any intellectual property or confidential information which I may know during the course of the Program and to comply with the instructions on confidentiality after the webinar.
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| Clause 3 | TO NOT COPY, CAPTURE, PHOTOGRAPH, RECORD OR USE ANY OTHER MEANS OF VISUAL OR AUDIO DUPLICATION, ANY PART OF THE MATERIAL PROVIDED DURING THE COURSE OF THE PROGRAM FOR ANY PURPOSE, SUCH AS SECONDARY USE OF THE INFORMATION THEREIN.
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| Clause 4 | To prepare myself for the live sessions of the Program;
- Learn specific contents of the E-learning course or other learning materials, that may be specified, to gain general knowledge about the subject,
- Submit all deliverables as instructed in each session before due as specified individually,
- Participate in the preliminary session,
- Fulfil any other obligations as may be required for the preparation.
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| Clause 5 | To participate actively in the live sessions of the Program;
- Place myself in the least distractive environment during the sessions not to disturb other participants,
- Refrain from engaging in any work other than the Program,
- Cooperate with other members of the group which I am assigned, if a group work is scheduled in the Program, and make best efforts to maximize the performance of such a group.
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| Clause 6 |
To provide feedback of my experience in the webinar to PMDA for future improvement.
- Submit the filled-out Evaluation Form of the sessions completed during the day and also the Evaluation Form for the overall seminar before due as specified individually.
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| Clause 7 | |
| Clause 8 | |