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  • REGULATORY AFFAIRS PHARMACOVIGILANCE - Goethe Business School
    The Pharmacovigilance section introduces PV management, covering how to build and manage a compliant pharmacovigilance organization, including budgeting and the use of smart PV tools The module also addresses challenges like pharmacovigilance audits and regulatory inspections faced by different types of pharmaceutical companies
  • Pharmacovigilance: Overview - European Medicines Agency (EMA)
    Also know as the PRAC impact strategy, it aims to shift the focus of pharmacovigilance towards the activities and regulatory tools that are most relevant to patients and make the greatest difference in daily healthcare The latest revision highlights the achievements attained since the strategy's launch, in its four key activity areas: effectiveness evaluation of risk-minimisation measures;
  • What are the difference between regulatory affairs and . . .
    Both Regulatory Affairs and Pharmacovigilance is covered under same course By integrating these two essential areas into a single program, learners gain a robust understanding of both the regulatory requirements necessary for bringing drugs to market and the ongoing safety monitoring required post-approval This dual specialization focus
  • Pharmacovigilance and Regulatory Affairs - ZS
    Pharmacovigilance, pharmacovigilance and drug safety, and pharmacovigilance regulatory affairs are critical to life sciences’ safety and regulatory teams Insights Insights Expertise and perspectives to create impact that matters See overview All Insights Impact Series Live, on-demand webinars and podcasts
  • Understanding the Intersection of Pharmacovigilance and Regulatory . . .
    Pharmacovigilance teams are responsible for detecting any new safety signals, whereas regulatory affairs teams ensure that any changes or findings are communicated to the relevant regulatory authorities and that appropriate actions (e g , label changes, safety warnings, or market withdrawal) are taken in compliance with regulatory requirements
  • Regulatory Affairs and Pharmacovigilance
    Regulatory Affairs (RA) involves ensuring that companies comply with all regulations and laws pertaining to drug development, approval, and marketing Pharmacovigilance (PV) refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems
  • Pharmacovigilance Regulatory Affairs | PharmExpert LLC
    Pharmacovigilance regulatory affairs ensures that pharmacovigilance systems meet the requirements of national and international regulatory authorities, such as the U S Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) PVRA professionals help pharmaceutical companies navigate these
  • The Role of Regulatory Affairs in Drug Safety and Pharmacovigilance
    Regulatory affairs and pharmacovigilance teams work closely together to ensure the safety, efficacy, and regulatory compliance of pharmaceutical products throughout their lifecycle While regulatory affairs teams are primarily responsible for ensuring that drugs meet the legal and regulatory requirements for approval and marketing
  • Pharmacovigilance, Regulatory Services, Quality and Compliance - Arriello
    We integrate regulatory, pharmacovigilance and quality compliance to ensure alignment with development milestones Why choose us With an unrivalled depth and breadth of expertise, coupled with a long track record of success, your products are safe in our hands





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