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2020³â 11¿ù 20ÀÏ(±Ý) ZOOM Webinar
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09:00~09:20 | °³È¸½Ä | |
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Ãà»ç 2 | PMRJ Àü¹« ½Ã°ÔÅ° Ã÷´Ù | |
09:20~10:35 | NIFDS ¼¼¼Ç : Quality Initiatives and International Harmonization Ç°Áú»óÀÇ °úÁ¦¿Í ±¹Á¦Á¶È |
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09:20~09:50 | Recent trends in drug quality reviews ÀǾàÇ° Ç°Áú½É»çÀÇ ÃÖ±Ù µ¿Çâ |
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09:55~10:35 | Control and perspectives of hazard impurities in drug products ÀǾàÇ° À¯ÇØ ºÒ¼ø¹°ÀÇ °ü¸® ¹× Àü¸Á |
±è³²Èñ ÁÖ¹«°ü ½ÄÇ°ÀǾàÇ°¾ÈÀüÆò°¡¿ø ÀǾàÇ°¿¬±¸°ú |
10:40~13:40 | PMRJ ¼¼¼Ç : Control Strategy and Practices of Mutagenic Impurities in Japan ÀϺ»ÀÇ º¯ÀÌ¿ø¼º ºÒ¼ø¹° °ü¸® Àü·« ¹× ½ÇÁ¦ |
¿À°Å³ªÀÌÀú : ½Ã°ÔÅ° Ã÷´Ù (PMRJ, Japan) ÁÂÀå : °Á¾¼º (Ãæ³²´ëÇб³) |
10:40~11:20 | Assessment and control of mutagenic impurities in pharmaceuticals ¿ÏÁ¦ ÀǾàÇ°ÀÇ º¯ÀÌ¿ø¼º ºÒ¼ø¹° Æò°¡ ¹× °ü¸® |
Masamitsu Honma, Ph.D. Deputy Director General, NIHS, Japan |
11:25~12:05 | Recent advances and challenges in the analysis of mutagenic impurities in pharmaceutical products ¿ÏÁ¦ ÀǾàÇ°ÀÇ º¯ÀÌ¿ø¼º ºÒ¼ø¹° ºÐ¼®ÀÇ ÃÖ±Ù ¹ßÀü°ú °úÁ¦ |
Eiichi Yamamoto, Ph.D. Section Chief, Drug Division, NIHS, Japan |
12:05~13:00 | Áᫎ | |
13:00~13:40 | Methods and issues of mutagenicity and carcinogenicity evaluation of pharmaceutical impurities based on ICH M7 guideline-From the viewpoints of practices for pharmaceutical businesses- ICH M7 °¡À̵å¶óÀο¡ ±Ù°ÅÇÑ ÀǾàÇ° ºÒ¼ø¹°ÀÇ º¯ÀÌ¿ø¼º°ú ¹ß¾Ï¼º Æò°¡ ¹æ¹ý ¹× °úÁ¦ - Á¦¾à»ê¾÷ÀÇ ½Ç¹« °üÁ¡¿¡¼ |
Tsukasa KIKUNO, Ph.D. President and CEO, PhiAS Co., Ltd., Japan |
13:45~14:25 | Special Invited Lecture | ÁÂÀå : Á¶Á¤È¯ (¼÷¸í¿©ÀÚ´ëÇб³) |
13:45~14:25 | Development, control and current status of JP reference standards ÀϺ»¾àÀü Ç¥ÁØÇ°ÀÇ °³¹ß, °ü¸® ¹× ÇöȲ |
Yukari Nakagawa, Ph.D. Director, Department of Reference Standard, PMRJ, Japan |
14:30~17:40 | RFPQ ¼¼¼Ç ¥² : Control and Practices of Mutagenic Impurities in Pharmaceutical Products ÀǾàÇ°ÀÇ º¯ÀÌ¿ø¼º ºÒ¼ø¹° °ü¸®¿Í ½Çü |
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14:30~15:10 | ICH Q9 : Quality risk management ICH Q9 : Ç°Áú ¸®½ºÅ© °ü¸® |
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15:10~15:30 | ÈÞ½Ä ½Ã°£ | |
15:30~16:10 | Isolation and purification of impurities in drug substances ¿ø·á ÀǾàÇ° Áß ºÒ¼ø¹°ÀÇ ºÐ¸® Á¤Á¦ |
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16:15~16:55 | Determination of nitrosamine and unknown impurity ID using LC-HR/AM Orbitrap with 2D LC 2D LC¿Í ÇÔ²² LC-HR / AM OrbitrapÀ» ÀÌ¿ëÇÑ ´ÏÆ®·Î»ç¹Î ÃøÁ¤ ¹× ¹ÌÁö ºÒ¼ø¹°ÀÇ È®ÀÎ |
°íÈÖ¿ø ¼ö¼® ½á¸ðÇǼŻçÀ̾ðƼÇÈÄÚ¸®¾Æ |
17:00~17:40 | Current status of the pharmaceutical industry and case studies by mandatory submission of mutagenic impurities data in Korea ±¹³» º¯ÀÌ¿ø¼º ºÒ¼ø¹° ÀÚ·á Àǹ« Á¦Ãâ¿¡ µû¸¥ Á¦¾à »ê¾÷ ÇöȲ ¹× »ç·Ê ¿¬±¸ |
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