| Day 1 |
|
| 08:00 –
08:30 |
Welcome
and Introduction |
| 08:30 –
09:30 |
Introduction to Clinical Drug Development – From Mouse to Man
- Interfaces between preclinical and clinical development
- Objectives of clinical trials
- Phases of clinical trials: Phase I – II – III - IV
|
| 09:30 –
10:45 |
Regulations for Clinical Trials – Part 1: International
- Declaration von Helsinki
- International Ethical Guidelines for Biomedical Research
Involving Human Subjects (CIOMS)
|
| 10:45 –
11:00 |
Break |
| 11:00 –
12:30 |
Regulations for Clinical Trials – Part 2: ICH
- ICH GCP (ICH E6):
Responsibilities of
- Ethics committees
- Clinical investigators
- Sponsors
- Monitors
- Auditors
- Inspectors E2A – Expedited Safety Reporting
- E3 – Clinical Study Report
- E8 – General Considerations for Clinical Trials
- E9 – Statistical Principles in Clinical Trials
- E10 – Choice of Control Groups
|
| 12:30 –
13:30 |
Lunch |
| 13:30 –
14:30 |
Regulations for Clinical Trials – Part 3: Europe
- Clinical Trials
Directive 2001/20/EC
- GCP Directive 2005/28/EC
- GMP Directive 2003/94/EC
|
| 14:30 –
15:30 |
Regulations for Clinical Trials – Part 4: US
- 21 CFR Part 11:
Electronic Records, Electronic Signatures
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 54: Financial Disclosure by Clinical Investigators
- 21 CFR Part 56: Institutional Review Boards
- 21 CFR Part 312: Investigational New Drug Application
|
| 15:30 –
15:45 |
Break |
| 15:45 –
16:45 |
Key
Documents in Clinical Trials – Part 1: Role, Structure, Content
- Investigator’s Brochure
- Study Protocol, Protocol Amendments
- Subject Information Sheet and Informed Consent Form
- Case Report Form
- Trial Report
|
| 16:45 –
17:30 |
Key
Documents in Clinical Trials – Part 2: Document Quality
- Common
errors or weaknesses
- Quality control procedures
|
| |
|
| Day 2 |
|
| 08:30 –
09:15 |
Monitoring and Managing Clinical Trials – Part 1
- Role and
Responsibilities of Clinical Monitors
- Investigator Site Selection and Qualification
- Pre-Study Site Visit
- Study Initiation Visit
- Interim Monitoring Visit
- Close-Out Visit
|
| 09:15 –
10:30 |
Workshop:
Preparation, Conduct and Follow-Up of Monitoring Visits |
| 10:30 –
10:45 |
Break |
| 10:45 –
11:30 |
Monitoring and Managing Clinical Trials – Part 2
- Documentation of
Monitoring Visits: Monitoring Report
- Communication with Investigator Sites, Sponsor, Project Team,
Contract Research Organizations (CROs), External Providers etc.
- Status Reporting
- Management of Time, Quality, Budget
|
| 11:30 –
12:30 |
Safety
Reporting in Clinical Trials
- Distinctions between AE, SAE, ADR,
SADR, SUSAR
- Seriousness, Expectedness, Relatedness of AEs
- Reporting Requirements and Timelines
- EudraVigilance Clinical Trial Module
- Documentation
|
| 12:30 –
13:30 |
Lunch |
| 13:30 –
14:45 |
- GCP
Quality Management System
- Components of a modern GCP Quality
Management System
- Quality Control and Quality Assurance: Roles, Responsibilities,
Differences
- Compliance in Clinical Trials
- Conducting QA Audits: Audit Types, Preparation, Conduct,
Reporting and Follow-Up, Interaction between Auditor and Auditee
|
| 14:45 –
15:30 |
Case
Studies: GCP Audit Observations |
| 15:30 –
15:45 |
Break |
| 15:45 –
16:45 |
Standard
Operating Procedures in Clinical Research
- GCP Requirements for
SOPs
- Writing practical and easy-to-understand SOPs
- SOP Lifecycle Management – from draft to archiving
- Role of SOPs in Audits and Inspections
- SOP Weaknesses
|
| 16:45 –
17:30 |
GCP
Inspections
- Audits and Inspections: Purpose and Differences
- Purpose, focus and time point of GCP inspections
- Overview on inspection processes and approaches
- How to prepare for a GCP inspection
- How to facilitate and behave during an inspection
- How to follow-up after an inspection
- How to respond to inspection reports
|
