DIA会员及用户请点击登录

登录

忘记用户 ID? or 忘记密码?

Not a Member?

创建账户并加入。

Sheraton Boston Hotel

2017 年 08 月 14 日 8:30 上午 - 2017 年 08 月 16 日 3:45 下午

39 Dalton Street, , Boston, MA 02119 , USA

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Precourse work – Drug Safety eLearning (can be done at anytime prior to live event)

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

Precourse work can be done at any time prior to the live event.

  • Module 1: Introduction to Drug Safety eLearning module
    • Lesson 1: The Basics
      • Definition of PV
      • History of PV
      • Overview of Drug Development and Clinical Trial Phases
      • Essential Premarketing PV Activities
      • PV in Postmarketing
    • Lesson 2: Terminology
      • Basic Terminology
      • Adverse Event Terminology
      • Medical Terminology
  • Module 2: Drug Safety Regulatory Requirements eLearning module
    • Lesson 1: Harmonization Initiatives
      • ICH
      • HL7
      • CDISC
      • CIOMS
      • ICH Safety Guidelines
      • CIOMS Documents
    • Lesson 2: Important US Regulations
      • US FDA Organization
      • FDA Resources for Industry
      • Legal Hierarchy in the US
      • Key US Laws and Guidances
    • Lesson 3: Important EU Regulations
      • EU Geography
      • EMA
      • Legal Hierarchy in the EU
      • Key EU Drug Safety Documents
    • Lesson 4: 2010 EU Legislation
      • Good Pharmacovigilance Practices
      • Product Authorization and Maintenance
      • Adverse Drug Reactions
      • PSUR Changes
      • Post-authorization Studies
      • Pharmacovigilance Master File
      • European Medicines Web Portal
      • Pharmacovigilance Inspections
      • Risk Management System
      • European Commission Reports
      • Pharmacovigilance Fees
Global Safety Regulatory Resources eLearning module

获得信息并保持参与

不要错失任何机会——请加入我们的邮件列表,了解DIA的观点和事件。