Page 13 - Shionogi flipbook NEW

Clinical Research
At Shionogi, innovation and entrepreneurial spirit drive our business. Through research and discovery, we develop medicines that enable pa- tients to live longer, healthier lives. Because patient safety is our number- one priority, we need to develop our products responsibly, in a way that always puts our patients rst. We adhere to all laws and regulations that apply to the safety and quality of our clinical research and development.
Together, we:
• Protect the safety of all individuals who participate in our clinical trials and research.
• Never participate in a clinical trial if we have an interest that could compromise our ability to be objective and fair.
Marketing and Sales
At Shionogi, our patients and the public at large trust us to provide honest and accurate information about our products. This means we must market and promote our products truthfully and in compliance with the law and all FDA regulations at all times, and we must never give the impression that our products may be used for something other than their intended use.
Together, we:
• Communicate all product information in a truthful manner.
• Never misstate or omit relevant safety information, or try to imply that a product can be used in a way that is not intended.
• Use and distribute only promotional and marketing material that has been approved by the Company.
• Ask questions if you have concerns about how to communicate about or market a product.
TO MAKE IT CLEAR...
We communicate honestly about our research so that human subjects can make informed decisions about their participation.
Before we begin clinical research, we fully disclose both risks and bene ts to participants and obtain their informed consent.
As a Company, we publicly disclose all clinical trial information in accordance with applicable laws, regu- lations and industry standards.
TO MAKE IT CLEAR:
Disclosure of Risks and Bene ts
When our patients use our products, they trust us with their safety.
When we communicate with patients, we must make complete and clear disclosures about the risks and ben- e ts of our products in accordance with FDA guidelines and Company policies.
BE MINDFUL:
Product Samples
In order for HCPs to try our products, our Company allows for the distribution of product samples, as long as we comply with the Prescription Drug and Market- ing Act (PDMA) as well as all regulations and company policies.
We must never sell or encourage others to sell drug samples. It is also important to remember that we need to store samples in accordance with PDMA.
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