Announcement
2014 APEC Harmonization Center Biotherapeutics Workshop:
Progress to Convergence
May 12 – 13, 2014
JW Marriott Seoul
Seoul, Republic of Korea
GENERAL INFORMATION
The APEC Harmonization Center (AHC) is organizing ‘2014 APEC Harmonization Center
Biotherapeutics Workshop: Progress to Convergence’ which will take place in Seoul, Korea on May
12-13, 2014. The Workshop is one-and-half day workshop back to back with the “WHO/MFDS
Implementation Workshop: Evaluation of biotherapeutic products” and “WHO/MFDS Implementation
Workshop: Evaluation of similar biotherapeutic products with emphasis on monoclonal antibody
products” which is held for three-and-half days (May 13-16, 2014).
The “2014 APEC Harmonization Center Biotherapeutics Workshop: Progress to Convergence”
will be held for one-and-half days, and it is a part of activities of the APEC Regulatory Harmonization
Steering Committee (RHSC) Roadmap to Promote Harmonization and Convergence of Regulatory Pathways
for Biotherapeutic Products. This workshop will brings together regulators from the APEC economies, World
Health Organization (WHO), industry representatives (local and global), and members of academia to discuss
challenges and opportunities to advance regulatory convergence of biotherapeutic regulation on a global scale.
There is no registration fee to participate in this Biotherapeutics Workshop; however, the space is
limited so we encourage all eligible participants to register online as soon as possible. APEC economies
are considered to be represented by regulators, industry representatives, and experts from academia. The
latest announcement, agenda, and the registration forms are located on the APEC Harmonization Center
website at www.apec-ahc.org. The workshop will be held in English, and English-Korean simultaneous
translation is only available in Korean.
WORKSHOP SCOPE (detailed agenda: Annex I)
The workshop will include:
 The current regulatory status and conditions of the APEC Economies based on regulatory
survey results.
 Life-cycle Management: post-approval variations focusing on CMC
 Clinical trials and immunogenicity
 Pharmacovigilance and risk management
PARTICIPANTS
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All APEC member economies are invited to participate.
Anticipated workshop attendees include regulators, industries, and academia.
Travel and per diem funding (including accommodation) will be provided for one (1)
participant from the following eleven APEC travel-eligible economies: Chile, China,
Indonesia, Malaysia, Mexico, Papua New Guinea, Peru, Philippines, Russia, Thailand and
Vietnam.
THE REPUBLIC OF KOREA VISA INFORMATION
 Visa Waiver countries (90 days): Thailand, Singapore, New Zealand, Malaysia, Peru, Mexico,
Chile
 Visa Free Entry: The United States (90 days), Hong Kong China (90 days), Japan (90 days),
Canada (6 months), Brunei Darussalam (30 days), Chinese Taipei (90 days), Australia (90
days)
 Visa Requirements: People`s Republic of China, Indonesia, Papua New Guinea, Russia, The
Philippines, Viet Nam
If you need further information, please go to http://www.mofat.go.kr/ENG/visa/application/
VENUE AND ACCOMMODATION
The workshop will take place at the JW Marriott Hotel, Seoul. Attendees are responsible for
their own hotel arrangements and costs. AHC funded participants are required to stay at the venue
hotel. Workshop participants should contact the hotel directly to make reservation using the following
points of contact.
1.
JW Marriott Hotel, Seoul (Venue Hotel)
Home page: www.jw-marriott.co.kr
Address: 176 Sinbanpo-ro, Seocho-gu, Seoul, Korea
E-mail: Sandy Park ([email protected])
Phone: 82-2-6282-6282
Room Rate: 235,000KRW
* The above rate is
- Subject to 10% Service charge and 11% Tax
- Inclusive of breakfast
Cut-off Date: April 30, 2014
2.
Seoul Palace Hotel
Home page: www.seoulpalace.co.kr
Address: 160 Sapyeong-daero(Banpo-dong), Seocho-gu, Seoul, Korea
E-mail: Jinsu Jeon ([email protected])
Phone: 82-2-2186-6766~8]
Room Rate: 190,000KRW
* The above rate is
- Subject to 10% Service charge and 11% Tax
- Inclusive of breakfast
Cut-off Date: April 30, 2014
※ Please let the hotel staff know that you are the APEC workshop participant for your reservation.
Hotels may provide special rates for participants of the APEC workshop. Room reservations must be
made no later than each Cut-off Date. After this date, any special accommodation rates may not be
applied.
PARTICIPANT REGISTRATION FORM
All participants wishing to attend the workshop are required to complete the workshop
registration form online only at www.apec-ahc.org (online registration will be opened on April 14 and
closed on May 4, 2014). Please keep in mind that space is limited, so participants are encouraged to
submit the required Registration Form as soon as possible. Participants from APEC economies may
include from regulatory agencies, industries, and academia.
ORGANIZATION
The APEC Harmonization Center is organizing the workshop.
CONTACTS
If you would like additional information please contact: APEC Harmonization Center
Secretariat ([email protected], Tel. 82-2-597-8668)
Annex I
2014 APEC Harmonization Center Biotherapeutics Workshop
Progress to Convergence Agenda
May 12-13, 2014
JW Marriott, Seoul, Republic of Korea
Sessions
Time
Day 1: Monday, May 12, 2014 : AHC Biotherapeutics Products Roadmap Session
8:00 - 9:00
Registration
Session 1: Welcome and Introduction
9:00 - 9:05
Opening remarks
9:05 - 9:10
Opening remarks
9:10 - 9:40
9:40 - 10:00
10:00 - 10:20
Welcome Remarks and Introduction to the AHC workshop, update on the Biotherapeutics
Roadmap
Read-out of the recommendations from the Sept 2013 AHC Workshop on Biotherapeutics;
Key Messages, Opportunities for Convergence
Coffee Break & Group Photo
Session 2: Areas of Convergence - Background
10:20 – 10:40
Readout of the RHSC Biotherapeutics Roadmap; Why, What and How?
10:40 – 11:10
Evaluation of biotherapeutics: From WHO guidelines to their implementation
Session 3: Technical, CMC Topics; Case Studies: Life-cycle Management: Post-approval
Variations - principles
11:10 – 11:45
WHO draft guideline on post-approval changes: scientific and procedural principles
11:45 – 12:20
Post-approval variations: Unique considerations for recombinant therapeutic products--(Based
on proposed revisions to WHO draft guidance initially intended for vaccines, currently under
review at IFPMA)
12:20 – 14:00
Lunch break
14:00 – 14:30
GMP inspections and work sharing within APEC (PIC/S model of cooperation)
Session 3(Continued): Technical, CMC Topics; Case Studies: Life-Cycle Management:
Post-approval Variations- Case studies
14:30 – 15:15
15:15 - 16:00
16:00 - 16:30
16:30 - 17:45
17:45 - 18:00
19:00 -
Use of multiple Manufacturing Sites for recombinant products: Comparability Requirements
for site transfer and long term Monitoring – Case Study with data (Link to ICH Q5E and
WHO guidance on recombinant products)
Post-approval changes: Stability Requirements for Drug Substance and Drug Product
Changes - Case Studies with data
Coffee break
Panel Discussion
Session Read-out and Recommendation
Reception(Hosted by AHC & MFDS)
Day 2: Tuesday, May 13, 2014 : Clinical, Safety, and Immunogenicity
Session 4: (TBD) Harmonization and Convergence
9:00 - 9:25
9:25 - 9:50
Establishing the criteria for acceptance of foreign clinical data based on ICH E5 for
Biotherapeutics
TBD) Overview and current status of APEC MRCT Roadmap – connection to Biotherapeutics
Roadmap?
9:50 - 10:15
Principles and immunogenicity risk management
10:15 - 10:30
Coffee break
10:30 - 10:55
(TBD)
10:55 - 11:20
Pharmacovigilance and risk management plans - are there unique considerations for BTP and
SBPs?
11:20 – 12:00
Panel Discussion - Convergence of WHO and RHSC Regulatory Harmonization Efforts
12:00 – 12:15
Session Read-out and Recommendations. Conclusion and close of Workshop
12:15 – 13:30
Lunch break
13:30 -
WHO Session