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In the context of globalization, more international clinical studies of psychotropics have been performed. A growing number of multinational pharmaceutical companies lead the early R&D of psychotropic drugs to China. Meanwhile, Chinese government has called for the development of critical pharmaceutical innovations and novel medical technologies, and launch new policies to fund support activities. The pharmaceutical industry in China has achieved remarkable success in the innovation of psychotropic drugs as a result.
Budget, Cost control and Agreement, are the key words in clinical trials. It is generally known that a reasonable budget is necessary to guarantee the smooth implementation of the trial, and help to reach quality requirements as well. A systematic and scientific “Clinical Trial Agreement” can clearly define the rights and responsibilities of both sides, and contributes to better cooperation. But the current situation is not optimistic. There are a few inharmonious opinions from sponsors and sites. |
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Chairman: |
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Gu Niufan
Professor
Shanghai Mental Health Center |
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Vice Chairman: |
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Li Xuening
Professor
Zhongshan hospital Fudan university |
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Li Huafang
Professor
Shanghai Mental Health Center |
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Professionals related to budget and agreement |
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Pharmaceutical industry: Project manager/Director etc. |
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CRO: Project manager/Director etc. |
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Site: PI/Leader and related staffs |
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Other: SMO/legal consultants etc. |
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Opinions on the reasons and solutions of "pay for equal work" in international multi-center clinical trials. |
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The impact of CPI when developing the budget of clinical trials (especially long term projects). |
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Is it necessary to sign "letter of intent" for clinical trials? If yes, when is to sign it? When is to sign the agreement? When and how to pay in clinical trials? |
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How to set up the motivation mechanisms to promote the enrollment and ensure the high quality when developing the agreement of the clinical trials? |
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How to make rules about compensation, insurance and warranty issues when developing the agreement of the clinical trials? |
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Which the agreement template is used of clinical trials from sponsor or site? If the template from sponsor is used, what are difficulties and the solutions of modification? |
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Conference Venue:
3rd Floor, Conference Room, Galaxy Hotel
Address: No.888 Zhongshan West Road, Changning
District, Shanghai 200051, China
Website: http://galaxyshotel.com/index.html
Tel: +86-21-51015566 |
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