应西安交通大学中国西部质量科学与技术研究院和电信学院叶凯教授的邀请，美国默克集团（在中国名为默沙东公司）副总裁 Marijke Pubben 女士将于4月10日——4月14日来我校进行访问，并作学术报告。

欢迎各位感兴趣的同学和老师参加，可盖章。

报告题目：Quality Management in Pharma and Biotech:

How to build a Quality Culture

时 间：4月13日下午3:00---5:00

地 点：科学馆207

摘 要：Regulators and Industry share a global mission to accelerate availability of (innovative) products to the world’s patients, consumers and healthcare providers. And thus to deliver compliant, safe, effective and affordable products when and where needed. These are crucial objectives with significant impact on global healthcare outcome. In the European Union, the holder of a Manufacturing Authorization (whether in industry or hospital) must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization, as appropriate, and do not place patients at risk due to inadequate safety, quality or efficacy.

The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by its distributors.

Being in compliance with the regulations is essential for the reputation of any (bio) pharmaceutical company. A culture of Compliance is a first step towards a culture of Quality. The key attributes to achieve a culture of Compliance and a culture of Quality are based on realizing the aspirations of ICH Q8, Q9 and Q 10 in combination with important behaviour and organization characteristics.

The lecture will address a comprehensive approach on how to ensure the above can be realized. It will include information as to “what success looks like” and how industry and regulators need each other to achieve the mission.