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RDPAC药品推广行为准则 - IFPMA

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法向具有相应处方权的医疗卫生专<br />

业人士提供限量的样品,以更好地<br />

服务于病患。所有样品均应被清楚<br />

标注,以防止其被转卖或以其他方<br />

式被滥用。<br />

8.2 有效控制和责任落实<br />

会员公司应对提供给医疗卫生<br />

专业人士的样品建立有效的控制和<br />

责任机制,包括对已交付给医药代<br />

表的样品实施监控。<br />

第九条 临床研究和透明度<br />

9.1 透明度<br />

会员公司致力于提高由其参与<br />

支持的临床试验的透明度,并意识<br />

到使执业医师、患者和其他人可从<br />

公开渠道获得临床试验信息符合公<br />

共健康的最大利益。而对此类信息<br />

的公布又必须严格保护个人隐私、<br />

知识产权、契约利益,并遵守现行<br />

专利法的立法、行政及司法理论与<br />

实践。<br />

会员公司应依照由国际制药<br />

企业协会联盟、欧洲制药企业协<br />

maceutical product may be supplied<br />

to healthcare professionals authorized<br />

to prescribe that product at limited<br />

amount for the purpose of familiarization<br />

of healthcare professionals<br />

with a product, in order to enhance<br />

patient care. Samples should be<br />

marked as such so that they cannot<br />

be resold or otherwise misused.<br />

8.2 Control and Accountability<br />

Companies should have adequate<br />

systems of control and accountability<br />

for samples provided to healthcare<br />

professionals including how to<br />

look after such samples whilst they<br />

are in possession of medical representatives.<br />

Article 9 Clinical Research<br />

and Transparency<br />

9.1 Transparency<br />

Companies are committed to the<br />

transparency of clinical trials which<br />

they sponsor. It is recognized that<br />

there are important public health<br />

benefits associated with making<br />

clinical trial information more publicly<br />

available to healthcare practitioners,<br />

patients, and others. Such disclosure,<br />

however, must maintain protections<br />

for individual privacy, intellectual<br />

property and contract rights, as well<br />

as conform to legislation and current<br />

national practices in patent law.<br />

29<br />

研<br />

制<br />

开<br />

发<br />

制<br />

药<br />

企<br />

业<br />

协<br />

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