Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

---

Скачать книгу

---

target="_blank" rel="nofollow" href="#litres_trial_promo"> Comments

       Shared System REMS

       REMS Template

       Comments

       European Union RMPs

       When is an RMP Needed?

       EU RMP Content

       Part I: Product(s) Overview (GVP V. B.4)

       Part II: Safety Specification (GVP V.B.5)

       Part III: PV Plan, Including Post-authorization Safety Studies (GVP V.B.6 RMP part III)

       Part IV: Plans for Post-authorization Efficacy Studies (GVP V.B.7 RMP part IV)

       Part V: Risk Minimization Measures (Including Evaluation of the Effectiveness of Risk Minimization Activities) (GVP V.B.8 RMP part V)

       Part VI: Summary of the RMP (GVP V.B.9 RMP part VI)

       General Remarks on the EU RMP

       Practicalities, Co-ordination, and Other Comments

       Risk Management within Pharma Companies

       Comments and Suggestions

       Chapter 29Data Monitoring Committees and Investigational Review Boards/Ethics Committees

       Data Monitoring Committees

       Investigational Review Boards/Ethics Committees

       Frequently Asked Questions

       Chapter 30Pharmaceutical Companies

       Introduction

       Big and Somewhat Big Pharma

       Mid-sized and Small Pharma

       Contract/Clinical Research Organizations

       Mergers, Acquisitions, and Bankruptcies

       Chapter 31Organization of a Typical Drug Safety Department

       Introduction

       Management

       Qualified (Responsible) Person for Pharmacovigilance

       Triage Unit

       Case Assessment and Prioritization

       Data Entry Unit

       Case Processing Unit

       Medical Case Review

       Transmission Unit

       PV Regulatory Intelligence

       Regulatory Unit

       Legal Unit

       Signaling, Pharmacovigilance, Pharmacoepidemiology, Medical Information or Medical Affairs Unit

       Aggregate Report Preparation

       Labeling Review and Update for Safety

       Archive/File Room

       Information Technology/Informatics Liaison

       Quality Documents Creation and Maintenance

       Training

       Quality Assurance/Control

       Safety (AE) Exchange Agreement Function: Creation and Maintenance

       Literature Review

       Data Dictionary Maintenance

       Coding Unit

       Planning and Project Management/Operations

       Risk Management

      

---

Скачать книгу