Regulations for Medicinal Products

Level 2

  • 1

    Module 1: History of the development of the regulations

    • slide 2

    • slide 3_1

    • 4_1

    • slide 5_1

    • slide 6_1

    • slide 7_1

    • slide 8

    • slide 9

    • slide 10_1

    • slide 11

    • slide 12_1

    • slide 13

    • slide 14_1

    • slide 15_1

    • slide 16

    • slide 17_1

    • slide 18

    • Knowledge Checkpoints 01

    • slide 19
  • 2

    Module 2: ICH GCP: Investigator responsibilities

    • ICH GCP: Introduction

    • ICH GCP: Transforming Health Care research in Africa

    • ICH GCP: Training Agenda

    • ICH GCP: What is ICH GCP 01

    • ICH GCP: What is ICH GCP 02

    • ICH GCP: Knowledge Checkpoints 01

    • ICH GCP: Investigator Responsibilities 01

    • ICH GCP: Investigator Responsibilities 02

    • ICH GCP: Protocol Compliance

    • ICH GCP: Knowledge Checkpoints 02

    • ICH GCP: 8 chapters

    • ICH GCP: Current status

    • Informed Consent _11

    • Informed Consent _12

    • Informed Consent info_13

    • Informed Consent info_14

    • Informed Consent info_15

    • Doc consent_16

    • Doc consent_17

    • Document Consent 18

    • Investigational Medicinal Product 19

    • Investigational Medicinal Product 20

    • Investigational Medicinal Product 21

    • ICH GCP: Safety Reporting

    • ICH GCP: Safety Reporting –Important Definitions

    • ICH GCP: Safety Reporting –Adverse Events

    • ICH GCP: Knowledge Checkpoints 06

    • ICH GCP: DATA Integrity

    • ICH GCP: Data Integrity_01

    • ICH GCP: Data Integrity - Source Data

    • ICH GCP: Data Integrity – Change Control

    • ICH GCP: Essential Documents

    • ICH GCP: Knowledge Checkpoints 07

    • ICH GCP: Monitoring – what to expect

    • ICH GCP: Monitoring – sponsor_01

    • ICH GCP: Monitoring – sponsor_02

    • ICH GCP: Monitoring – sponsor_03

    • ICH GCP: Knowledge Checkpoints 08

    • ICH GCP: Summary
  • 3

    Module 3: Clinical Trial Approval and ongoing Regulatory requirements

    • slide 2

    • slide 3

    • slide 4_1

    • slide 5_2

    • slide 6_1

    • slide 7

    • slide 8_1

    • slide 9

    • slide 10_1

    • slide 11_1

    • slide 12_1

    • Knowledge Checkpoints 01

    • slide 13_1

    • slide 14_1

    • slide 15_1

    • slide 16_1

    • slide 17

    • Knowledge Checkpoints 02

    • slide 18_1

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.