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Workshop

Title

Bio-Pharmaceutical Safety and Regulatory Affairs Management (Bangladesh)

Type Workshop
Venue Date 2015-11-12 ~ 2015-11-26
Host KOICA Organizer

Bio-Pharmaceutical Safety and Regulatory Affairs Management (Bangladesh)​

(November 12 – November 26, 2015) 

 

Date/Time Program Description
Day 1: Nov 12 (Thu)
-

Arrival

Day 2: Nov 13 (Fri)
-

KOICA Orientation

Day 3: Nov 14 (Sat)

-

Seoul City Tour & Move to Daejeon Intercity Hotel

Day 4: Nov 15 (Sun)

-

-

Day 5: Nov 16 (Mon) Opening Ceremony / Country Report / Lecture

08:15-09:30 

 Move to MFDS, Osong

09:30-09:45 

 Registration / Opening ceremony

09:45~10:10 

 Introduction / Welcome remark
 (Bangladesh participants, MFDS training staff)

10:10~10:20   Group photo session
10:20~11:20   MFDS orientation
11:20~13:00   Welcoming luncheon
13:00~15:30   Country Report
   13:00~13:45        1. Group 1 Presentation
   13:50~14:35       2. Group 2 Presentation
   14:40~15:25       3. Group 3 Presentation
15:30~15:40   Break
15:40~17:40   [Lecture 1] Biopharmaceutical Safety Control System and Supporting  Trend for Industry
17:40~18:00   Wrap-up / Daily survey
18:00~  Back to hotel
Day 6: Nov 17 (Tue) Lecture
08:00~09:15  Move (Hotel → MFDS)
09:15~09:30  Morning meeting
09:30~11:00  [Lecture 2] License․Review for Biologics I
11:00~11:10  Break
11:10~12:10   [Lecture 3] License․Review for Biologics II: Case study
12:10~13:10   Lunch
13:10~14:10   [Lecture 4] Understanding of Biopharmaceutical GMP
14:10~14:15   Break
14:15~15:15   [Lecture 5] GMP for Biopharmaceuticals I
15:15~15:35   Break
15:35~16:35   [Lecture 6] GMP for Biopharmaceuticals II
16:35~16:40   Break
16:40~17:40   [Lecture 7] Introduction of Action Plan
17:40~18:00   Wrap-up / Daily survey
18:00~  Back to hotel
 Day 7: Nov 18 (Web) Lecture / On-site Visit
08:00~09:15   Move (Daejeon → MFDS)
09:15~09:30   Morning meeting
09:30~11:00   [Lecture 8] License․Review for Recombinant Protein
 Products I
11:00~11:10   Break
11:10~12:10   [Lecture 9] License․Review for Recombinant Protein
 Products II: case study
12:10~13:10   Lunch
13:10~14:10   [Lecture 10] GMP for Biopharmaceuticals III: case
 study
14:10~14:30   Break
14:30~16:30   [Lecture 11] National Center for Lot Release
16:30~17:00 

  On-site 

  Tour 1

 [Site Tour 1] Visit: National Center for Lot Release     
17:00~17:30   Wrap-up / Daily survey
17:50~  Back to hotel
 Day 8: Nov 19 (Thu) Field Trip / Action Plan Preparation 1
07:45~08:00   Morning meeting
08:00~09:30   Move (Daejeon → Eum-sung)
09:30~10:00 

  [On-site 

  Tour 2

 Introduction: Il-yang Pharm.
10:00~11:00   [On-site Tour 2] Vaccine Manufacturing Plant
 and Facility Management
11:00~12:30    [Lecture 12] Manufacturing Process / Quality
 Management for Vaccines
12:30~14:00   Lunch
14:00~15:30   Move (Eum-sung → Osong, MFDS)
15:30~17:30   Action Plan preparation I
 How to make action plan: analyzing, message delivery
 and discussion
17:30~17:45   Wrap-up / Daily survey
17:45~  Back to hotel
 Day 9: Nov 20 (Fri) Action Plan Preparation 2 / Field Trip
08:00~09:15   Check-out of the Intercity Hotel &
 Move (Daejeon → MFDS)
09:15~09:30   Morning meeting
09:30~11:00   Action Plan preparation II
 : Feedback, Improvement, Discussion
11:00~12:00   Lunch
12:00~15:00   Move: Osong → Incheon
15:00~15:30 

   Field Trip

 Introduction: Celltrion
15:30~16:00 

  Study visit: Biosimilar manufacturing plant and     facility management

16:00~16:45   [Lecture 13] Manufacturing process for bio-similar
16:45~17:30   [Lecture 14] Quality control for bio-similar
17:30~17:45   Wrap-up / Daily survey
    17:45~  Check-in at Incheon Orakai Hotel
 Day 10: Nov 21 (Sat) City Tour
10:00~11:30   Check-out of the Incheon Orakai Hotel &
 Move (Incheon → Seoul)
11:30~13:00   Lunch
13:00~14:20   Sightseeing tour: Samsung Delight
14:20~14:50   Move (Samsung Delight → Korea Culture House)
14:50~16:00   Korean Culture Hand-on experience
16:00~  Check-in at the Daejeon Intercity Hotel
 Day 11: Nov 22 (Sun) 
-

-

 Day 12: Nov 23(Mon) Lecture / Action plan Preparation 3
08:00~09:15   Move (Daejoen → Osong, MFDS)
09:15~09:30   Morning meeting
09:30~11:00   [Lecture 15] License․Review for Cell Therapy Products
11:00~11:10   Break
11:10~12:10   [Lecture 16] License․Review for Gene Therapy
 Products
12:10~13:10   Lunch
13:10~15:10   [Lecture 17] National Lot Release: Blood Products
15:10~15:30   Break
15:30~17:30   Action Plan preparation III
17:30~  Back to hotel(Ochang → Daejeon)
 Day 13: Nov 24 (Tue) Action Plan Preparation 3/ Field Trip
07:45~09:00   Move (MFDS → LG Life Science)
09:00~09:30 

 

  On-site
   Tour 3

 

 Introduction: LG Life Science
09:30~10:30   [On-site tour 3] On-site Tour: Recombinant Protein
 Products Manufacturing Plant and Facility  Management
10:30~12:00   [Lecture 18] Recombinant Protein Products:
 Manufacturing Process and Quality Management  Status
12:00~13:00  Lunch
13:00~14:30   Move (Osong → Ochang)
14:30~15:00    
 On-site
 Tour 4

 


 
 Introduction: Green Cross
15:00~16:00   On-site tour 4] Blood Products Manufacturing
 Site Tour & Introduction of Facility Management
16:00~17:00   [Lecture 19] Manufacturing process and quality
 control for blood products
17:00~17:30   Wrap-up / Daily survey
17:30~  Back to hotel(Ochang → Daejeon)
 Day 14: Nov 25 (Wed) Action Plan Presentation / Clsong Ceremony
9:40~10:00   Morning meeting
   Action Plan Presentation
10:00~12:30  10:00~10:45   1. Group 1 Presentation
 10:50~11:35   2. Group 2 Presentation
 11:40~12:25  3. Group 3 Presentation
12:30~14:00   Farewell luncheon
14:00~14:30   Course Evaluation
14:30~15:00   Closing Ceremony / Farewell remark
15:00~17:00   Move to KOICA
17:00-18:30   KOICA Evaluation Session & Departure Oreintation
Day 15: Nov 26 (Thu) Departure
-  Departure