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[±¹°¡ÀÓ»ó½ÃÇèÀç´Ü] 2019 KoNECT-MOHW-MFDS International Conference
±¸ºÐ ÁÖÃÖ/ÁÖ°ü
°³ÃÖÀÏ Àå¼Ò
µî·ÏÀÏ 2019-05-28 ÷ºÎÆÄÀÏ
E-mail ÀüÈ­
ȨÆäÀÌÁö http://www.konectintconference.org

2019 KoNECT-MOHW-MFDS International Conference ¾È³»¹®

 

±¹°¡ÀÓ»ó½ÃÇèÀç´Ü(KoNECT)Àº ¿ÃÇØ·Î 5ȸ°¸¦ ¸ÂÀÌÇÏ´Â 2019 KoNECT International Conference ¸¦9¿ù 18ÀÏ(¼ö) ~ 19ÀÏ(¸ñ), [Pre-Workshop 17ÀÏ(È­)] º¸°Çº¹ÁöºÎ¿Í ½ÄÇ°ÀǾàÇ°¾ÈÀüó¿ÍÀÇ °øµ¿ÁÖÃÖ·Î ¿©Àǵµ ÄÜ·¡µå È£ÅÚ¿¡¼­ °³ÃÖÇÕ´Ï´Ù.  

ƯÈ÷, ¿ÃÇØ´Â “Accelerating Clinical Development, Bringing Hope to Patients”ÀÇ ÁÖÁ¦·Î ÀÓ»ó½ÃÇè ÃֽŠµ¿ÇâÀ» °øÀ¯ÇÏ°í, ÀÓ»ó½ÃÇè°ú ½Å¾à°³¹ßÀÇ »õ·Î¿î µµÀü°ú ºñÀü ±×¸®°í Çù·ÂÀ» ³íÀÇÇÏ´Â ÀÚ¸®·Î ¸¸µé°íÀÚ ÇÕ´Ï´Ù.
¾Æ½Ã¾ÆÀÇ ´ëÇ¥ÀûÀÎ ÀÓ»ó½ÃÇè ±¹Á¦Çà»çÀÌÀÚ Àü¼¼°è 20°³±¹ 1,000¿©¸íÀÇ Àü¹®°¡µéÀÌ ÇÑÀÚ¸®¿¡ ¸ðÀÌ´Â Çù·ÂÀÇ ÀåÀÎ KoNECT International Conference¿¡ ÇÔ²²ÇÏ¿© ÀÚ¸®¸¦ ºû³» Áֽñ⠹ٶø´Ï´Ù.

 

*WHY KIC? The reasons to attend
1.
ÀÓ»ó½ÃÇè ±ÔÁ¦ Á¤º¸ ¹× µ¿Çâ (Regulatory Updates)
ºü¸£°ÔÀ» ÅëÇØ, Çѱ¹, ÀϺ», Áß±¹À» Æ÷ÇÔÇÑ ¿©·¯ ±¹°¡ÀÇ ±ÔÁ¦ÇöȲ, IND, ÀÓ»ó½ÃÇè Àü·«¿¡ ´ëÇÑ Á¤º¸¸¦ ¾òÀ» ¼ö ÀÖ½À´Ï´Ù. ƯÈ÷, ¿ÃÇØ´Â ´Ù¼öÀÇ ½ÄÇ°ÀǾàÇ°¾ÈÀüó(MFDS) ¹ßÇ¥°¡ ¿¹Á¤µÇ¾î ÀÖ½À´Ï´Ù.
*
ÅäÇÈ º° Target Audience ÷ºÎ¹®¼­ ÂüÁ¶
- Workshop 1. Biologics CMC for IND [9
¿ù 17ÀÏ]
- Workshop 3. How to Manage Safety in Clinical Development; Lessons Learned [9
¿ù 17ÀÏ]
- Session 1. Impact of NMPA Reform in China [9
¿ù 18ÀÏ]
- Session 1. Regulatory Updates on Japan [9
¿ù 18ÀÏ]
- Session 1. Regulatory Updates on Korea [9
¿ù 18ÀÏ]
- Session 1. Regulatory Updates on US FDA or EMA [9
¿ù 18ÀÏ]
- Session 3. Use of Real World Evidence to Support Regulatory Decision Making [9
¿ù 18ÀÏ]
- Session 4. Challenges in Drug/Device Combination Products Trials (by MFDS) [9
¿ù 18ÀÏ]
-
ÀÌ ¿Ü ´Ù¼ö¼¼¼Ç
 


2.
ÀÓ»ó°³¹ß ¹× ÀÓ»ó½ÃÇè Operation¿¡ ¹Ù·Î Àû¿ë °¡´ÉÇÑ ½Ç¹«ÀûÀÎ ³íÀÇÀÇ Àå
½Ç¹«¿¡ ¹Ù·Î Àû¿ë °¡´ÉÇÑ ½Ç¿ëÀûÀÎ À̽´ ¹× ÀÓ»ó½ÃÇèÀÇ ÃֽŠÁö°ßÀ» ¼÷ÁöÇÏ¿© ÀÓ»ó°³¹ß ¹× ÀÓ»ó½ÃÇè Operation¿¡ Á÷Á¢ÀûÀÎ µµ¿òÀ» ÁÙ ¼ö ÀÖ½À´Ï´Ù.
- Workshop 2. Risk Based Quality Management [9
¿ù 17ÀÏ]
- Workshop 3. How to Manage Safety in Clinical Development; Lessons Learned [9
¿ù 17ÀÏ]
- Session 9. Advancing Patient Protection in Clinical Trials [9
¿ù 19ÀÏ]
- Session 13. Quality Planning and Management in Protocol Execution [9
¿ù 19ÀÏ]
- Session 14. Success to NDA through Optimal Study Design [9
¿ù 19ÀÏ]
-
ÀÌ ¿Ü ´Ù¼ö¼¼¼Ç
 

  

3. Á¦¾à»ç, ¹ÙÀÌ¿ÀÅØÀ» À§ÇÑ ÀÓ»ó°³¹ßÀÇ ÃֽŠÁ¤º¸ ¹× ½ÇÁ¦  

½Å¾à°³¹ßÀÇ °¢ ´Ü°èº° Á¢±Ù»Ó ¾Æ´Ï¶ó ÀüÁÖ±â ÀÓ»ó½ÃÇèÀÇ ±Û·Î¹ú ÃֽŠÁ¤º¸¸¦ Á¢ÇÒ ¼ö ÀÖ½À´Ï´Ù.  

- Session 7. Interpretation of Non- Clinical Finding for Better Clinical Trials [9¿ù 18ÀÏ]  

- Session 2. Successful Outsourcing Strategy in Clinical Development [9¿ù 18ÀÏ]  

- Workshop 4. Maximizing Success in Immuno-Oncology Drug Development [9¿ù 17ÀÏ]  

- Session 11. Creating Value through Clinical Development [9¿ù 19ÀÏ]  

- Session 10. Pioneering the fundamental, Gene & Cell Therapy [9¿ù 19ÀÏ]  

- Session 12. Early Engagement of Biomarker in Drug Development [9¿ù 19ÀÏ]  

- Session 14. Success to NDA through Optimal Study Design [9¿ù 19ÀÏ]  

- ÀÌ ¿Ü ´Ù¼ö¼¼¼Ç  

  

4. ¼º°øÀûÀÎ ÀÓ»ó½ÃÇèÀ» À§ÇÑ ºñÀÓ»ó½ÃÇèÀÇ ½ÇÁ¦  

- Session 7. Using Pre-Clinical Data to Inform Clinical Trials [9¿ù 18ÀÏ]  

- Session 7. Non-Clinical Development of Various Cases [9¿ù 18ÀÏ]  

  

5. ±¹³»¿Ü ÁÖ¿äÁ¦¾à»ç, CRO, ¹ÙÀÌ¿ÀÅØ ¹× À¯°ü±â¾÷À» ÇÑ ÀÚ¸®¿¡¼­ ¸¸³ª º¼ ¼ö ÀÖÀ¸¸ç, ƯÈ÷, ±¹³» ÀÓ»óCRO Fair ¸¦ ÅëÇØ Çѱ¹ ÁÖ¿ä ÀÓ»óCROµéÀ» ÇÑÀÚ¸®¿¡¼­ ¸¸³ª °¢»çÀÇ ¼­ºñ½º¿Í ¿ª·®À» µéÀ» ¼ö ÀÖ´Â ÀåÀÌ ¸¶·ÃµÇ¾î ÀÖ½À´Ï´Ù.  

  

6. ¹Ì±¹ FDA, ÀϺ» PMDA¸¦ ºñ·ÔÇÑ ÇØ¿Ü Á¤ºÎ±â°ü ¹× ±Û·Î¹ú À¯°ü±â°ü, ´ëÇÐ µî¿¡¼­ Âü¿©ÇÏ´Â ¿¬ÀÚµéÀ» ÅëÇØ ÃÖ½ÅÁö°ß ½Àµæ ¹× ±Û·Î¹ú ³×Æ®¿öÅ©¸¦ ±¸ÃàÇÒ ¼ö ÀÖ½À´Ï´Ù.  

  

7. ÄÁÆÛ·±½º ±â°£ Áß, ºñÁî´Ï½º ÆÄÆ®³Ê¸µ ¹ÌÆ÷ëÀÌ º°µµ·Î Á¦°øµÇ¸ç ´©±¸³ª ÀÚÀ¯·Ó°Ô ÀÌ¿ëÇÏ½Ç ¼ö ÀÖ½À´Ï´Ù. KIC À¥ÆäÀÌÁö¿¡¼­ »çÀü¿¡ Âü¼®ÀÚ¸¦ °Ë»öÇÏ¿© ¹ÌÆÃÀ» ¿äûÇÒ ¼ö ÀÖ´Â ½Ã½ºÅÛÀÌ ¸¶·ÃµÇ¾î ÀÖ¾î, È¿À²ÀûÀÌ°í ºü¸¥ ÀÇ»ç¼ÒÅëÀÌ °¡´ÉÇÕ´Ï´Ù. (À¥»çÀÌÆ®-Partnering Ä«Å×°í¸® ÂüÁ¶)  

  

8. ÀÌ ÄÁÆÛ·±½º´Â ½ÄÇ°ÀǾàÇ°¾ÈÀüó¿¡¼­ ÁöÁ¤ÇÑ ÀÓ»ó½ÃÇèµî Á¾»çÀÚ Á÷´É°øÅë ½ÉÈ­, º¸¼ö±³À°À¸·Î ÀÎÁ¤µÇ´Â ±³À°°úÁ¤ÀÔ´Ï´Ù.  

  

2019 KoNECT-MOHW-MFDS International Conference Âü°¡¹®ÀÇ 

-       µî·Ï/Àü½Ã ¹®ÀÇ»çÇ×: info-kic@konect.or.kr  

-       °ø½ÄÀ¥»çÀÌÆ®: www.konectintconference.org  

  

  

*º°Ã·. ¼¼ºÎÇÁ·Î±×·¥ ÇöȲ ÂüÁ¶