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 ¡EConcept of GRM ¡EAchievements of APEC Roadmap to promote GRM ¡EObjectives of this year's workshop |
17 Mins | Chia-Ping Liu Section Chief |
Session 2 | Planning of Application ¡EPlanning of New Drug Application & Example of Registration ¡EPlanning of Generic Drug Application & Example of Registration |
30 Mins | Finny Liu APAC Regional Regulatory Policy Lead Roche Singapore |
33 Mins | Jocelyn Lee Senior Regulatory Manager |
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Session 3 | Preparation of Application Dossier ¡EStandard process of application dossier preparation ¡ESupport tools (template, glossary, checklist & timeline table) |
23 Mins | Kumiko Hikida Manager Global Regulatory Affairs Department Mitsubishi Tanabe Pharma Corporation APAC |
Session 4 | Managing and Conducting the Review ¡EExample of implementing GRevP in the review process |
20 Mins | Wan-Yu Chao Specialist |
Session 5 | Using Facilitated Regulatory Pathways (FRPs) for Special Case Authorizations
|
50 Mins | Lawrence Liberti Adjunct Research Professor |
Session 6 | Communication with Applicants-Regulator’s Aspects
|
10 Mins | Ting-Yao Wang Project Manager |
Communication ~Industries¡¦ Aspects~ ¡ESharing importance of effective communication based on APEC RHSC Good Submission Practice Guideline for Applicants |
10 Mins | Shinji Hatakeyama Leader |
|
Topic of Special Interest I: Orphan Drug Regulations | |||
Session 7 | Regulatory Perspective of Orphan Drug Development for Rare Diseases |
12 Mins | Yen-Hui Wu Deputy Director |
An Overview of the European Orphan Regulation
|
28 Mins | Kristina Larsson Head of Office |
|
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
|
18 Mins | Atsushi Noguchi Deputy Review Director |
Evolving Role of Real-Word Data (RWD) & Evidence (RWE) in Drug Development
|
30 Mins | Alexander Liede Senior Director Head of Evidence and Partnerships |
PART 2: Webinar
DAY 1: September 13th, 14h00-17h00 ( GMT+8 Time )
TOPIC | TIME | SPEAKER |
---|---|---|
Group Discussion 1: Case Study: Planning of Submission and Preparation of Application Dossier | ||
Overview on New Drugs & Generic Drugs Cases | 14h00-14h15 | ¡iModerator¡j |
Discussion on New Drugs & Generic Drugs Cases (4 groups of New Drugs/ 3 groups of Generic Drugs) |
14h15-15h15 | |
Break Time | 15h15-15h25 | |
Group Presentation I (4 groups of New Drugs, around 8 mins/group) | 15h25-16h10 | |
Group Presentation II (3 groups of Generic Drugs, around 8 mins/group) | 16h10-16h50 | |
Q&A / Wrap Up | 16h50-17h00 |
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 |
14h00-14h10 | ¡iModerator¡j |
Case discussions (7 groups) | 14h10-15h10 | |
Presentations (Groups A to C, around 8 mins/group), 3 groups | 15h10-15h35 | |
Break Time | 15h35-15h45 | |
Presentations (Groups D to G, around 8 mins/group), 4 groups | 15h45-16h20 | |
Q & A | 16h20-16h30 | |
Wrap Up & Take Home Messages | 16h30-16h40 |
DAY 3: September 15th ,08h30-11h10 ( GMT+8 Time )
TOPIC | TIME | SPEAKER |
---|---|---|
Brief Opening | 08h30-08h40 | Shou-Mei Wu (TFDA) |
COVID-19 Vaccine Pharmacovigilance: TFDA’s experience | 08h40-08h50 | Jo-Feng Chi (TFDA) |
Modular study design within a vaccine safety program |
08h50-09h15 | Daina Esposito |
Q & A Time | 09h15-09h20 | |
US FDA Pilots: Project Orbis, Real Time Oncology Review (RTOR), Assessment Aid
|
09h20- 09h45 | Heidi Wang |
Q & A Time | 09h45-09h50 | |
Virtual Photo Time (With All Speakers and Guests) | 09h50-09h55 | |
ACCESS Work-sharing model | 09h55- 10h20 | John Skerritt |
Q & A Time | 10h20- 10h25 | |
Gulf Health Council, experience in Reliance (Pre-recorded) |
10h25- 10h50 | Hajed M. H. Hashan |
Brief Announcement | 10h50- 10h55 | |
Closing Remarks I (Pre-recorded) |
10h55-11h00 | Junko Sato |
Closing Remarks II | 11h00-11h05 | Shinji Hatakeyama |
Closing Remarks III+ Virtual Photo Time (With All Participants) | 11h05-11h10 | Shou-Mei Wu |
¡¯ The program may be subjected to change.