谈判你的方式通过警协议迷宫-有更好的方法吗?
Catherine Corbel-Ecalard1, Jean Kilgour-Christie2, Weronika Trun3
1Amgen Inc., Thousand Oaks, CA, USA.
Therapeutic innovation & regulatory science
|June 3, 2023
概括
由于行业的增长,制药公司面临复杂的药监协议 (PVA). 本研究介绍了简化这些合作伙伴关系的工具和技术,增强患者安全和监管合规性.
科学领域:
- 药物监督 药物监督 药物监督
- 制药行业 制药行业 制药行业
- 监管合规性 监管合规性
背景情况:
- 药监协议 (PVA) 的景观随着制药合作伙伴关系,并购和收购的增加而变得越来越复杂.
- 监管审查加强了,但对PVA的详细指导仍然很少,导致公司具体流程的分歧.
- 在这种复杂的情况下,营销许可证持有者 (MAHs) 寻求有效的解决方案来确保患者的安全和合规性.
研究的目的:
- 解决制药行业中制定药监协议 (PVA) 的挑战.
- 通过行业合作,探索在药监合同协议中的简化和效率.
- 开发和实施工具和技术,以促进许可证持有者的合作伙伴关系,以提高患者安全.
主要方法:
- 对营销许可持有者 (MAHs) 进行了调查,以了解对PVA复杂性的看法.
- 分析了制定和管理药监协议的现有挑战.
- 开发并领导新型工具和技术的实施,以促进 MAH 的合作.
主要成果:
- 调查结果证实了感知到的复杂性和需要有效的解决方案来管理PVA.
- 确定了对标准化方法的需求,以应对药监合同的复杂要求.
- 成功开发并启动使用工具和技术来促进持有者合作伙伴关系.
结论:
- 制药监督协议 (PVA) 的制定需要简化解决方案来管理日益复杂的情况.
- 整个行业的合作,例如通过联盟,对于优化PVA流程至关重要.
- 实施的工具和技术提供了一条途径,通过更好的营销许可证持有人伙伴关系来加强患者安全和药监管合规性.
相关概念视频
Pharmacovigilance
914
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
914
Ethical Dilemmas II
1.2K
Resolving an ethical dilemma in healthcare involves a systematic approach that considers every aspect of the issue, respecting both the patient's needs and values and the healthcare professional's ethical obligations. Here are potential steps to resolve an ethical dilemma:
1.2K
Persuasion Strategies
38.8K
Researchers have tested many persuasion strategies, including the foot-in-the door and the door-in-the-face techniques, in a variety of contexts. Ultimately, the principles are effective in selling products and changing people’s attitude, ideas, and behaviors (Cialdini & Goldstein, 2004).
38.8K
Obedience
32.9K
According to obedience research, we may harm others under the forceful pressures of an authority figure (Milgram, 1974). How about if the inappropriate orders were delivered with less force? The increasing interdependence between nurses and physicians compelled Hofling and his colleagues to explore nurses’ reactions to a potentially harmful medical request made by the perceived authority figure, the doctor (Hofling, Brotzman, Dalrymple, Graves, & Pierce, 1966). In this situation,...
32.9K
Aggression
27.9K
Humans engage in aggression when they seek to cause harm or pain to another person. Aggression takes two forms depending on one’s motives: hostile or instrumental. Hostile aggression is motivated by feelings of anger with intent to cause pain; a fight in a bar with a stranger is an example of hostile aggression. In contrast, instrumental aggression is motivated by achieving a goal and does not necessarily involve intent to cause pain (Berkowitz, 1993); a contract killer who murders for...
27.9K
Ethical Dilemmas I
963
Ethical dilemmas in nursing are of utmost importance, as they often arise from the tension between adhering to core ethical principles and the practical realities of healthcare delivery. These dilemmas require nurses to navigate complex situations where competing ethical considerations pull them in different directions.
Let us explore some examples to understand the potentially complex moral decisions nurses face.
Take the case of caring for minors, particularly in areas related to reproductive...
Let us explore some examples to understand the potentially complex moral decisions nurses face.
Take the case of caring for minors, particularly in areas related to reproductive...
963


