Day 1. ˘x Common Sessions (reviewers & applicants) Room 401
Time | Subjects | Speakers |
08:30~08:45 |
Opening remarks |
|
08:45~09:15 |
Keynote Speech 1: Basic Concept of GRM |
|
Basic Concept of GRM | Chao-Yi Wang |
|
09:15~10:00 |
Session 1. An Overview of Good Review and Good Submission |
|
Lecture 1: An overview of principles of good review and WHO GRevP guidelines | Yi-Chu Lin |
|
Lecture 2: An overview of principles of good submission and APEC GSubP guidelines | Osamu Inagaki |
|
Q&A | ||
10:00~10:15 |
REFRESHMENT BREAK |
|
10:15~10:45 |
Keynote Speech 2: The Role of Good Review Practices in Building Quality Review Process – Canadian Experience |
|
The Role of Good Review Practices in Building Quality Review Process – Canadian Experience |
Christopher Antonio |
|
10:45~12:30 |
Session 2. Experience Sharing from Different APEC Member Economies |
|
Current status and challenges of local training and implementation of GRM in APEC member economies
|
||
12:30~13:30 |
LUNCH |
Day 1. afternoon ˘x
Reviewer-Specific Sessions Room 402AB
Time | Subjects | Speaker |
13:30~15:30 |
Session R1. Managing and Conducting the Review
Session Chair: Li-Jiuan Hsu |
|
Experiences sharing from invited experts Lecture 1: An overview of managing and conducting the review based on the WHO GRevP Guidelines |
Hsien-Yi Lin |
|
Lecture 2: Experience sharing on new drug applications | Hsin-Jung Lee |
|
Lecture 3: Generic Medicine Applications – A regulator’s experience |
Keith McDonald |
|
Q&A | ||
15:30~15:45 |
REFRESHMENT BREAK |
|
15:45~17:45 |
Session R2. Managing and Conducting the Review |
|
Experiences sharing from trainees |
Day 1. afternoon ˘x
Applicant-Specific Sessions Room 402CD
Time | Subjects | Speaker |
13:30~15:30 |
Session A1. Planning of Application |
|
Introduction | SAPI/IRPMA |
|
What do we want | Rosa Fu |
|
What do we need |
Thean Soo Lo |
|
How do we do it | Sannie Chong |
|
Q&A |
Jenny Chang |
|
15:30~15:45 |
REFRESHMENT BREAK |
|
15:45~17:45 |
Session A2. Good Submissions for Generic Drug Applications |
|
Lecture 1: Good Submission Practice in Malaysia & ASEAN | Gan Ching Ching |
|
Lecture 2: Good Submissions for Generic Drug Applications | Jocelyn Lee |
|
Q&A | Gan Ching Ching |
|
Experiences sharing from trainees |
Day 2 ˘xReviewer-Specific Sessions Room 402AB
Time | Subjects | Speakers |
08:30-10:10 |
Session R3. Review Personnel – Critical Thinking |
|
Part I : Fundamentals and case studies on review of new drug applications |
Shih-Ying Yang |
|
10:00~10:40 |
REFRESHMENT BREAK |
|
10:40~12:00 |
Part II : Generic Medicine Applications – A regulator’s experience |
Keith McDonald |
12:00~13:30 |
LUNCH | |
13:30~15:30 |
Session R4. Communication - Fundamentals and Case Studies for Regulatory Authorities |
|
Discussion among reviewers based on WHO GRevP Guidelines section 5 |
Min Chen |
|
Communication Practices – Canadian Experience | Christopher Antonio |
|
Communication practices in Philippines FDA | Benjamin G. Co |
|
15:30~15:45 |
REFRESHMENT BREAK |
|
15:45~16:45 |
Wrap up |
Day 2 ˘xApplicant-Specific Sessions Room 402CD
Time | Subjects | Speakers |
08:30-09:30 |
Session A3. Preparation of Application Dossier/ Practice: How to Prepare Application Dossier |
|
Introduction |
Shinji Hatakeyama |
|
Ice Breaker |
Jenny Chang |
|
Dossier Preparation |
Osamu Takarada |
|
09:30~10:00 |
REFRESHMENT BREAK |
|
10:00~12:00 |
(Continue) Session A3. Practice: How to Prepare Application Dossier |
Shinji Hatakeyama |
Group presentation (5 groups) | All speakers of A3 | |
12:00~13:00 |
LUNCH | |
13:00~15:30 |
Session A4. Effective Communications - Focusing Follow-up Actions During Review Period /Practice: Case Study of How to Handle Inquires |
|
Introduction |
Toru Yamada |
|
Ice Braking Game |
||
Introduction for communication |
||
Practice 1 |
Kyoko Ueda |
|
Practice 2 |
Mari Toji |
|
Practice 3 |
Naoko Matsui |
|
15:30~15:45 |
REFRESHMENT BREAK | |
15:45~16:45 |
Wrap up |
Day 3˘xDay 3 Common Sessions Room 402
Time | Subjects | Speakers |
08:30-10:30 |
Session 3. Communications |
|
08:30~08:40 |
Introduction : How to improve communications and apply critical thinking for decision making |
Kazuo Ushio |
08:40~08:55 |
Introduction for Group Discussion on the following 2 topics: |
Min Chen |
08:55~09:35 |
Group Discussion | |
09:35~10:15 |
Presentation from each group (5 mins x 6 groups) | |
10:15~10:30 |
Closing |
Junko Sato |
10:30~10:45 |
REFRESHMENT BREAK |
|
10:45~12:00 |
Session 4. Competencies and Training for Reviewers and Applicants |
|
10:45~11:00 |
Presentation |
Silke Vogel |
11:00~11:15 |
Presentation |
James Leong |
11:15~12:00 |
Discussion |
Silke Vogel |
12:00~13:30 |
LUNCH | |
13:30~15:15 |
Session 5. Rolling Out the GRM Training Program in Each Economy |
|
13:30~14:00 |
Presentation |
Kae Nakashima |
14:00~14:15 |
Presentation |
Silke Vogel |
14:15~15:15 |
Application and Role-Playing |
Silke Vogel |
15:15~15:30 |
REFRESHMENT BREAK | |
15:30~16:30 |
Wrap up |
GRM CoE Representative |
16:30~16:40 | CLOSING REMARKS Room 401 |