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研讨会内容
| 研讨会名称 | 医學院學术演讲-Prof. Peter M A Calverley |
|---|---|
| 开始日期 | 2017-07-14 12:30:00 |
| 结束日期 | 2017-07-14 14:00:00 |
| 活动说明 | 医學院医學系胸腔内科于2017年7月14日(星期五)，特别邀请全球临床試验的总PI-Prof. Peter M A Calverley分享临床試验之经验，Prof. Calverley将以How to design a successful global trial in respiratory disease为题分享，以期促进學术之合作交流。 演讲摘要: Drug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH) has initiated the process for having a harmonized guidance document on MRCT. A well-designed, robust study strategy, whether it is for a first-in-human study or for a study on a specific patient population, will generate early value signals that can help you avoid these entanglements. Such a strategy looks beyond the limited safety and proof-of-concept goals of traditional early studies, by examining these studies within the larger context of product life-cycle development, portfolio optimisation and long-term return on investment. In the end, an effective and comprehensive study strategy helps accelerate product approval and market entry by identifying and addressing operational, medical, safety, regulatory and payor issues early on. It may even enhance the value of an asset by investigating the therapeutic potential of new products beyond their initial proposed indication – or lead to early termination of programmes that do not pan out, reducing waste of limited development resources. |
| 主要联絡Mail | com@tmu.edu.tw |
| 参考连结 | |
| 附件档案 | Poster_speech  |
