• Program & Speaker
  • PIC/S BTCA Expert Circle Meeting

PIC/S BTCA Expert Circle Meeting

  • -Date : 2017. 6. 26. ~ 6. 28.
  • -Venue : Oakwood Hotel(Seoul, Korea)

Draft Proposal of Topics and Structure of Program

Day 0 Sunday 25 June (Co-ordinating Committee Pre-meeting), Intercontinental Hotel

Time Program Attendee Room
16:00~18:00 Co-ordinating Committee Pre-meeting Members of Co-ordinating Committee Business Center

Day 1 Monday 26 June (Current Regulatory Framework and Harmonization), Oakwood Hotel

Time Program Speaker Room
08:00~09:00 Registration Premier
09:00~09:20 Welcome Address Dr. Dong-hee Lee (General Director), MFDS, Korea
09:20~09:30 Opening Comments Dr. Marisa Delbo (Chair person), AIFA, Italy
09:30~09:50 Updates on Expert Circle on Human Blood, Tissues, Cells & ATMPs Dr. Marisa Delbo, AIFA, Italy
09:50~10:20 Coffee Break
10:20~10:40 Overview of Blood and Tissue Donor Eligibility Dr. Diane Maloney, FDA, US Premier
10:40~11:00 Donor Eligibility of Blood, Cell & Tissue: Regulatory Perspective (Europe) Ms. Matilde Moreno García, AEMPS, Spain
11:00~11:20 Donor Eligibility of Blood, Cell & Tissue: Regulatory Perspective (Korea) Dr. Jeewon Joung, MFDS, Korea
11:20~11:40 Questions and Discussion Presenters
11:40~11:50 Group Photo Session
12:00~13:00 Lunch Restaurant
13:00~15:00 Concurrent Workshop 1;
Case Study (Inspection – Blood Establishment)
Dr. Jose Manuel Cardenas, SETS, Spain
Dr. Luis Roberto Larrea Gonzalez, VBTC, Spain
Premier
15:00~15:30 Coffe Break
15:30~17:30 Concurrent Workshop 2
Case Study (Inspection – ATMPs Manufacturer)
Dr. Maria Cristina Galli, ISS, Italy
Mr. Choon Wee Goh, HSA, Singapore
Oak
18:00~21:00 Welcome Dinner MFDS Invitation COEX Restaurant

Day 2 Tuesday 27 June (Communication with Academia & Industry and Visiting Facilities), Oakwood Hotel

Time Program Speaker Room
09:00~09:30 Update on EU GMP Guideline for ATMPs Dr. Ian Rees, MHRA, UK Premier
09:30~10:00 Initiating Cell and Gene Therapy: New Progress for the Pharmaceutical Industry Dr. Joseph Tarnowski, GSK, USA
10:00~10:20 Questions and Discussion Presenters
10:20~10:50 Coffee Break
10:50~11:20 Management of Cell Banking System; Industrial Perspective Dr. Sam Yaghmour, Amgen, USA
11:20~11:50 GMP-Grading HLA Homozygote Induced Pluripotent Stem Cell Banking Dr. Ji Hyeon Ju, Catholic University, Korea
11:50~12:00 Questions and Discussion Presenters Premier
12:00~13:00 Lunch Restaurant
13:00~18:00 Visit Facility (divided 3 groups)
- Blood Fraction Facility
- Tissue Production Facility
- ATMP Production Facility
Red Cross Fraction Center (Blood)
CG Bio (Human Tissue)
Kolon Life Science (ATMP)
Eum-sung
Sung-nam
Chung-Ju

Day 3 Wednesday 28 June (Gaining Knowledge and Wrap-up), Oakwood Hotel

Time Program Speaker Room
09:30~10:10 Structural & Procedural Measures for Risk Management in ATMP Manufacturing Dr. Maria Cristina Galli, ISS, Italy Premier
10:10~10:20 Questions and Discussion Presenter
10:20~10:40 Coffee Break
10:40~12:10 Plenary Discussion (Outcome of Workshop) Facilitators
12:10~12:20 Closing Remarks Chair Person
12:20~14:00 Farewell Lunch

Day 3 Wednesday 28 June (Co-ordinating Committee Post-meeting), Intercontinental Hotel

Time Program Attendee Room
14:30~16:30 Co-ordinating Committee Post-meeting Members of Co-ordinating Committee Business Center

Accommodations

Please check the list of hotels by clicking this button.

  • Step 1 Choose a hotel
  • Step 2 Download the reservation form from the hotel list and fill it out
  • Step 3 Send the completed form directly to the desired hotel