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It is important for regulatory and development staffs to make a decision about drug development based on scientific evidence, while understanding the current drug development environment and having a wide view regularly. Furthermore, clinical trials should be conducted under regulations and medical condition, and require reliable results. However, sometimes common procedure does not work well for actual development and review when scientific progress intervene. The final decision about drug approval has been reached based not only on clinical trial results, but also on various factors at the time of approval. Sometimes several stakeholders share opposing views due to their difference of position and philosophy in a review process. Is it possible to persuade various stakeholders based on scientific data?

Regulatory and development staff might face these complex situations and be forced into an important decision-making bind. It is quite difficult to convince the other party to change their opinion. Appropriate evaluation based on regulatory science is required for drugs to be accepted by sponsors and regulatory authorities, as well as patients and health care professionals. If staff fail to achieve a balanced decision, the drug will not be regarded as having a favorable benefit/risk balance in its actual use.

In this training course, participants will play the role as reviewer and make a decision about mock product. All participants will be divided into several groups and share their decision* with the group. Each group will be required to discuss and put together a conclusion, and make a presentation about the group decision, explaining their rationale for the conclusion and respond to facilitators’ comments on their conclusion. In this training course, participants will learn accountability for various stakeholders such as patients, parents, academic societies, doctors, nurses, company CEOs, and regulatory authorities. This training course will be a unique workshop and benefit regulatory and development professionals.