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2014,11,17【國際臨床試驗菁英講座】-Management of International Clinical4
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Management of International Clinical Trials –

Aspect of Medical and Safety and Experience Sharing

  • Time17 Nov(Mon), 2014 / 13:30-17:00                                                                              

  • LocationCollege of Law, National Taiwan University (臺灣大學法律學院霖澤館)

  • SponsorTaiwan Salt and Light Biotech Institute (台灣光鹽生物科技學苑)

  • Registration FeeNT 2500 (全程英文演講, Q&A可由專人翻譯)

  • Who should attend? product managers, project managers, clinical trial managers, site investigators, reviewers, regulatory affairs, or even CRAs or staffs of medical department.

【講座內容簡介】

隨著台灣新藥國際化的腳步,對於臨床試驗的國際執行實務需求殷切,本學苑特別邀請三位來自德國具有豐富實務經驗的臨床試驗專家 Liang-Ni Wu, James Visanji, Clare Visanji,他們將藉由案例分享,不僅止於德國而是國際的臨床試執行的經驗,包括Sponsor, Regulatory agency, 以及CROClinical Trial Management中扮演的角色及溝通。內容涵蓋A key to successful clinical research”, ”Medical Writing and Clinical Study Protocol Development”,”  A survival guide to audit preparation in Clinical Trials”,期望台灣新藥公司、國際大藥廠以及國內法規單位、臨床試驗中心等專業人能藉由本講座共同分享國際臨床實務作法。

13:30-14:00 Registration                                                                     

14:00-14:05 Opening and Welcome      Peishan Tsai

14:05-14:30 Knowing the Differences and Learning from the Best       Liang-Ni Wu

- a key to successful clinical research

14:30-15:30 Medical Writing and Clinical Study Protocol Development  James Visanji

A high-quality Clinical Study Protocol (CSP) is essential for a successful clinical trial. The CSP is a multifunctional document that serves several purposes. As well as being the key reference manual for all study personnel, including investigators, the sponsor study team, and drug safety staff, it is essential to the protection of patients, fulfillment of GCP requirements, and the eventual analysis and reporting of study data. The protocol also drives Case Report Form design, so a carefully written protocol can ensure that instructions (especially inclusion and exclusion criteria) are clear to the investigator, and that the required assessments are performed and data captured at the right times during the patient’s progress through the study. This seminar will look at ways the study design team can write a clear and unambiguous protocol to contribute to a successful and scientifically valid outcome.

Q&A

15:30 Break

16:00-17:00  A survival guide to audit preparation in Clinical Trials         Clare Visanji

In this session, you will hear about

WHAT to know regarding audits and inspections

WHEN to start preparing for an audit

HOW to prepare for and to attend audit queries (or in another title, HOW to participate in an audit)

WHO is responsible for audit preparation? - How to help your team

WHY audits?!

Q&A

 

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