【新藥開發系列】CRO主題課程一日營:如何掌握CRO報價、試驗品質暨法規諮詢成效之經驗分享! (6/15 下午場)

2019/06/15 (早鳥限額預約中)
【預約/報名】 我要報名/限額早鳥
 
<課程簡介> 歡迎RA及新藥系列舊生回訓

第一個分享主題:主要以常見問答的方式,舉例說明若公司已有臨床研發計畫,下一步預計與CRO公司合作時,在合作前,或合作中間會注意的幾個重點部分。例如合作前,如何看懂多家CRO報價,進而提供對整體試驗經費的掌控。在合作進行中,同時兼顧經費花費及高品質的臨床試驗。期望透過列出常見的一些兩邊不同觀點,進而促進與CRO建立理想合作的模式,讓試驗順利甚或於提早順利結束。
 
第二個分享主題:包括說明美國及一些亞洲國家的臨床試驗申請流程, 其中與法規單位諮詢是一個很重要的步驟。課程將舉例列出目前有提供法規諮詢的幾個國家, 其申請諮詢流程,時程安排及審查要求。另外,如何把握有限的諮詢時間,有效率的掌握諮詢的方向及清楚的列出諮詢問題,也是與法規單位諮詢中,非常重要的一個部分。
 
下午場單元時數配當
下午場
1.CRO: Stumbling block or stepping stone
Few things you need to know before working with CRO
1:30 – 3:00 Ingrid Lo
VP, Clinical Operations, APAC
Break : 下午茶點/交流 3:00 – 3:30  
2. Regulatory consultant process for IND application
(US/EU/APAC)
3:30 – 4:30 PeiLing Shih
Regulatory and Strategic Development Exec Dir
Q&A   /交流 4:30 – 5:00 All
賦歸    
 
下午場講師介紹:

Ingrid 羅嘉瑜 副總裁(丘以思公司)
  • Ingrid also has 15 years of extensive global clinical experience in various therapeutic areas such as Infectious disease, Oncology, Cardiovascular, Head and Neck cancer, Alzheimer and Vaccine.
  • Prior to Clinipace, former Choice Pharma, Ingrid joined Quintiles Clinical Research Organization as Sr. Clinical Research Associate, and GlaxoSmithKline Pharmaceutical Company as Associate Clinical Research Director, managed global clinical study set-up and follow up study activities throughout study progress, and ensured high performance and efficiency of the clinical team.  Evaluated quality and integrity of the study site practices related to the proper conduct of the protocol and adherence applicable to regulations. Ingrid is responsible for clinical conductions in APAC region, including Australia, China, Japan, Korea, Malaysia, Singapore, and Taiwan. 
     
    PeiLing Shih 施佩玲 亞太區法規事務處長(丘以思公司)
  • Pei-Ling has more than 20 years of regulatory affair experiences and she has worked for well-known international pharmaceutical companies like Abbott, MSD, and GE Healthcare Taiwan with responsibilities in ASEAN Region.
  • Prior to joining Clinipace, Pei-Ling was a Regulatory Affairs Manager in Merck Sharp & Dohme, Pei-Ling had successfully led a new vaccine registration in 3 months lead time to 1st worldwide approval.  Pei-Ling led her team completed 80 to 100 regulatory projects yearly in average with high quality.  Pei-ling also led GE Healthcare Taiwan successfully coordinated 4 Asia Pacific distribution markets and resolved long-outstood regulatory issues for Thailand, Indonesia and Malaysia. PeiLing now is the contact of Clinipace RSD (Regulatory and Strategy Development) based in US to provide consultation service to our APAC client.  
【上課日期/時間】2019/6/15(週六)
【上課地點】台北市大安區和平東路二段106號4樓(科技大樓)
【課程費用】
  • 全修班(上/下午全修): NT :5,200非團體會員;NT: 4,800協會團體會員
  • 單元班:(上午或下午場):單場次一律 NT4,500
【優惠方案】 我要報名/限額早鳥
  • 超級早鳥優惠: 5/1 前完成報名及繳費者,只要NT$ :4,500元 (早鳥限量優惠:限額10人)

補充:

上午場主題為: 如何與臨床委外研究機構共事
下午場主題為: 如何掌握CRO報價、試驗品質及提升法規諮詢成效之經驗分享!
 
【預約/報名】 我要報名/限額早鳥

【諮詢專線】02-77003883 分機11或 分機12 歡迎來電

(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權,如有變動將會提前通知)