RSS Newsfeed  Your shopping cart.
ECA Academy - Your GMP/GDP Information Source
SEARCH

Search in

Keyword

 

In-house Training Programme

 
 

Basic Course in Good Clinical Practice

 
     
 
When What
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
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

 

 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Microbiology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Validation
 Medical Devices
 GMP Basic Training Courses
 Packaging