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RDPAC药品推广行为准则 - IFPMA

RDPAC药品推广行为准则 - IFPMA

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研<br />

制<br />

开<br />

发<br />

制<br />

药<br />

企<br />

业<br />

协<br />

会<br />

会联盟、日本制药企业协会、及<br />

美国药品研发与制造商协会共同<br />

发布的《通过临床试验注册平台<br />

与数据库公开临床试验信息的联<br />

合声明(2009)》,以及《在科<br />

学文献中公开临床试验结果的联<br />

合声明(2010)》公开临床试验<br />

的信息。<br />

9.2 与推广行为的区别<br />

30<br />

所有对人体进行的科学研究均<br />

须有正当的科学目的。对人体进行<br />

的科学研究,包括临床试验和观察<br />

性试验,均不得成为隐藏或掩饰的<br />

药品推广活动。<br />

注释22<br />

第十条 对医学继续教育的支持<br />

医学继续教育可帮助医疗卫<br />

生专业人士掌握有关疾病和相关治<br />

疗手段的最新、最准确的信息和观<br />

点,这对改善病患服务、提升医疗<br />

卫生服务水平是极为重要的。继续<br />

教育的主要目的应当是提升医学知<br />

识,会员公司仅在此目的下提供的<br />

资金支持才是正当的。<br />

Companies disclose clinical trial<br />

information as set out in the Joint<br />

Position on the Disclosure of Clinical<br />

Trial Information via Clinical Trial<br />

Registries and Databases (2009)<br />

and the Joint Position on the Publication<br />

of Clinical Trial Results in the<br />

Scientific Literature (2010) issued by<br />

the <strong>IFPMA</strong>, the European Federation<br />

of Pharmaceutical Industries and<br />

Associations (EFPIA), the Japanese<br />

Pharmaceutical Manufacturers Association<br />

(JPMA) and the Pharmaceutical<br />

Research and Manufacturers of<br />

America (PhRMA).<br />

9.2 Distinct from Promotion<br />

All human subject research must<br />

have a legitimate scientific purpose.<br />

Human subject research, including<br />

clinical trials and observational studies,<br />

must not be disguised promotion.<br />

ANNOTATION 22<br />

Article 10 Support for Continuing<br />

Medical Education<br />

Continuing medical education (CME)<br />

helps ensure that healthcare professionals<br />

obtain the latest and most<br />

accurate information and insights<br />

on therapeutic areas and related<br />

interventions that are critical to the<br />

improvement of patient care and<br />

overall enhancement of the healthcare<br />

system. The primary purpose of<br />

an educational meeting must be the<br />

enhancement of medical knowledge

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