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Previous Workshops

Day 1

Wednesday, September 25
Wednesday, September 25:Time, Speakers / Description, Sessions

Time

Speakers / Description

Sessions

8:00 - 9:00 Registration
Opening Ceremony
9:00 - 9:05 Byoung-guk Kim (MFDS) Welcome Remarks by Program Chair
9:05 - 9:10 Jin-Ho Wang
(Director, AHC)
Opening Address
9:10 - 9:15 Byung-Won Jang
(Vice Minister, MFDS)
Words of Encouragement
9:15 - 9:20 Won-Bae Kim
(Chairman, KPMA)
Congratulatory Remarks
9:20 - 9:35 Romi Singh (Amgen) . Special Remarks
. Introduction and Outline of the 2013 Biotherapeutics Workshop
9:35 - 9:50 Soon-wook Hong (MFDS) Keynote Speech
9:50 - 10:05 Coffee Break & Group Photo
Session 1: Overview of Biotherapeutics, and a Roadmap Towards Convergence
. Coordinator: Jerry Stewart (Pfizer)
. Chair: Yeowon Sohn (MFDS)
. Co-Chair: Jerry Stewart (Pfizer)
10:05 -10:30 Kum Cheun Wong
(IFPMA)
Biologics vs. Small Molecule Pharmaceuticals
10:30 -10:55 Jane Bai (IFPMA) Current Development/Regulatory Strategies of Biotherapeutic
Products -Key Points to Consider vs Small Molecules
10:55 -11:10 Hyuk Jae Lee (Celltrion) Progress and Update on Biosimilars Development in Korea
11:10 -11:30 Byoung-guk Kim (MFDS) Overview of Biotherapeutic Roadmap
11:30 -11:50 Jerry Stewart (Pfizer) AHC 2012 Biosimilars Workshop Output
11:50 -12:10 Judith Macdonald (Pfizer) Biosimilar Regulatory Frameworks with Room for Convergence, What more is needed?
12:10 -12:40 Panelists: Session Chairs,
Speakers,
Invited
Participants
Conclusion and Q&A, Round Table Discussion
12:40 -14:00 Luncheon
Session 2: ICH and WHO role in setting standards for biotherapeutic products
. Coordinator: Romi Singh (Amgen)
. Chair: Ivana Knezevic (WHO)
. Co-Chair: HongZhang Yin(CFDA)
14:00 - 14:35 Ivana Knezevic (WHO) Development and Implementation of WHO Guidelines for Regulatory Evaluation of Biotherapeutic Products
14:35 - 14:55 Jian Wang (Health Canada) Key Issues that Regulators should Consider While Reviewing CT Data
14:55 - 15:15 Panelists: Invited Participants Discussion
15:15 - 15:50 Mike Ward (Health Canada) ICH Current Status and APEC Regional Harmonization Efforts
15:50 - 16:05 Coffee Break
16:05 - 17:20 Panel Discussion - Opportunities for regulatory convergence
Yvonne Khoo
(NPCB, Ministry of Health,
Malaysia)
Evaluation of Biologics in Malaysia
Yasuhiro Kishioka
(PMDA)
Evaluation of Biologics in Japan
Panelists:

1) Chinese Taipei
    (Fia (Ya-Ting) Chen,
    Ministry of Health and
    Welfare)
2) Japan
    (Yasuhiro Kishioka, PMDA)
3) Korea
    (Jeewon Joung, MFDS)
4) Malaysia
    (Yvonne Khoo,
    NPCB, Ministry of Health)
5) Thailand
    (Prapassorn Thanaphollert,
    Ministry of Public Health)
6) China
    Industry Representative
    (Romi Singh, Amgen)
Discussion:

1. How do Various Economies use WHO and ICH Guidelines?
2. What are the opportunities for regulatory convergence?
17:20 - 17:50 Ivana Knezevic (WHO) - Review of the day and wrap up
- Conclusion and read-out from Day 1
18:00 - Reception (Hosted by AHC & MFDS)

Day 2

Thursday, September 26
Day 2:Thursday, September 26 : Time, Speakers / Description, Sessions

Time

Speakers / Description

Sessions

Session 3: Clinical / Non-Clinical (Case study)
. Coordinator: Lila Feisee (BIO)
. Chair: Jian Wang (Health Canada)
. Co-Chair: David Hutto (Eisai)
9:00 - 9:45 David Hutto (Eisai) Non-clinical ICH S6 (Non-clinical evaluation of biotechnology products)
9:45 - 10:15 Shalini Gupta (Amgen) The Importance of Immunogenicity Assessment of Therapeutic Proteins
10:15 - 10:30 Coffee Break
10:30 - 11:00 Dr. Freddy Faccin (AbbVie) Clinical data requirements for registration of biotherapeutics
11:00 - 11:35 Panelists: Session Chairs,
Speakers,
Invited
Participants
Q&A and Roundtable Discussion
Session 4: CMC Considerations: Manufacturing and Quality
. Coordinator: Wassim Nashabeh (Genentech)
. Chair: Chung Keel Lee (MFDS)
. Co-Chair: Wassim Nashabeh (Genentech)
11:35 - 12:15 Kowid Ho
(Roche)
ICH guidelines for biologics
12:15 - 13:15 Luncheon
13:15 - 13:45 Mats Welin
(Medical Products Agency)
Review of recent ICH Quality guideline focused on enhanced process/product understanding (ICH Q8-11)
13:45 - 14:05 Lynne Krummen (Genentech) Feasibility of application of ICH Q8-11 to Biotherapeutic products
14:05 - 14:25 Richard Lit (Amgen) LifeCycle Management for Biotherapeutics: The Complex world of post-approval changes
14:25 - 14:45 Chung Keel Lee (MFDS) GMP highlights in Biopharmaceuticals
14:45 - 15:15 Panelists: Session Chairs,
Speakers,
Invited
Participants
Q&A and Roundtable Discussion
15:15 - 15:30 Coffee Break
Plenary Lecture: New Upcoming Biotherapeutics Technology
15:30 - 16:15 James Merson (Pfizer) High-level overview of new innovative technologies in biotherapeutics
16:15 - 16:45 Moderator:
Teruhide Yamaguchi (PMDA)

Panelist:
Invited Participants
Q&A and Roundtable Discussion
16:45 - 17:15 Wassim Nashabeh
(Genentech)
Review of the day and wrap up
Conclusion and read-out from Day 1 & 2
17:15 - 17:20 Sun Hee Lee (MFDS) Closing Remarks by MFDS

Day 3

Friday, September 27
Day 3:Friday, September 27 : Time, Speakers / Description, Sessions

Time

Speakers / Description

Sessions

Debrief and Discuss
9:00 - 10:00 Speakers, Session Chairs, Regulators Discuss the content of the "White paper" or the meeting report
10:00 - 11:00 Regulators only Session
. Chair: Ivana Knezevic (WHO)
. Co-Chair: Yeowon Sohn (MFDS)
Discuss the results of the WHO Survey and evaluate opportunities for regulatory convergence amongst DRAs
11:00
- Afternoon
Visit a local Korean Biotec (Hanmi Pharmaceutical Co., Ltd.)