RDPAC药品推广行为准则 - IFPMA
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