Drug Safety

Level 2

  • 1

    Module 1: Short Overview of Drug Safety

    • Drug Safety Introduction

    • Clinical Research & Drug Safety
  • 2

    Module 2: Drug Safety – Definitions and Reporting Requirements

    • 03_What does it mean?

    • 04_Why collect safety data?

    • 05_Pharmacovigilance - What is this?

    • 06_Pharmacovigilance - Why is it needed?

    • Knowledge Checkpoints 1

    • 07_Key terms used in clinical trials

    • 08_Definitions - Adverse Event

    • 09_Definitions - Serious Adverse Event

    • 10_Definitions - Adverse Reaction

    • 11-12_Definitions - SUSAR - Adverse Events Family

    • Knowledge Checkpoints 2
  • 3

    Module 3: Specific Safety Roles within trials eg DSMB

    • 13_Reporting of Adverse Events during

    • 14_How are Adverse Events Collected?

    • 15_What are the Barriers to Complete Reporting?

    • 16_Reporting of Adverse Events during your Clinical Trial

    • 17_Physician Assessment of Adverse Events

    • 18_When is it an Adverse Drug Reaction?

    • 19_Physician Assessment of Adverse Events

    • 20_Physician Assessment of Adverse Events

    • 21_Physician Assessment of Adverse Events

    • Knowledge Checkpoints 3
  • 4

    Module 4: Post-marketing Safety

    • 22_Reporting of Serious Adverse Events

    • 23_Reporting Timelines For SUSARs- -1

    • 24_Reporting Timelines For SUSARs- -2

    • Knowledge Checkpoints 4

    • 25_What have you learnt?

Instructor

Chief Operating Officer

Dr Tina Barton

Dr. Tina Barton, Chief Operating Officer of eMQT, is a drug development specialist with over 40 years’ experience, working in partnership to lead for success as a customer-focused senior leader. During this time Dr. Barton has invested in training for the future – through team leadership, individual mentoring and training thereby sharing knowledge and developing professionals. Through her role at the Institute of Clinical Research she continues to support and lead training activities. With a passion for transformation, Dr. Barton drove the embracement of Central Eastern European countries and now is focused on the inclusion of Sub-Saharan Africa into clinical development – bringing the miracle of development of new medicines to emerging markets and new patients. Dr. Barton holds a BSc, PhD and MBA alongside over 50 academic publications and is an Honorary Fellow, and Board Member of the Institute of Clinical Research.