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1·Do the Qualified person and other key persons receive continuous training in regulatory affairs and in analytical and production technology?

在法规事务、检验技术和生产技术方面，对质量受权人和其他关键人员有持续性的培训吗？

2·Thus, this product is an unapproved new drug and violates federal law,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.

因此,该产品是一种未经批准的新药，违反了联邦法律。

3·Bruce Watzman, senior vice President for regulatory affairs at the National Mining Association, an industry group, urged the committee not to impose increased regulation.

布鲁斯·瓦茨曼，作为行业组织全国矿业协会监管事务的高级副总裁，敦促委员会不要强行增加监管。

4·Support Regulatory Affairs as needed for domestic and international submissions from manufacturing perspective required by the US FDA, China CFDA and international submission in designated countries.

支持本地和国际法务工作，需要时支持中国和国际生产注册提交，以符合美国FDA及中国FDA和各国的要求。

5·Howard J. Feldman, the director of regulatory and scientific affairs at the American Petroleum Institute, noted that the evidence of a causal factor was inconclusive for some ailments.

美国石油研究所负责监管和科学事务的所长霍华德j·费尔德曼指出，证据表明废气对某些疾病的发生并不起决定性作用。

6·Develop site regulatory and clinical affairs strategy, and subsequent implementation plan.

制定公司法规及临床事务战略，以及随后的实施计划。