Please see below a list of training topics that we cover through our International Network of Trainers (INT). Those can be delivered as an in-house training sessions or webinars as well.
If you do not see the course you require or have specific needs that you would like to discuss, please telephone 0044 208 123 3324, or e-mail info@astranovatraining.co.uk
Good Clinical Practice (GCP) Training Topics
- Introduction to GCP
- Monitoring and Auditing Clinical Laboratories
- GCP Compliance for Monitors
- Advanced Quality Assurance
- GCP for Investigators
- GCP for Monitors
- GCP for site staff
- Overview UK GCP (local legislation specifics)
- GCP Refresher
- Clinical Trial Directive
- GCP for Pharmacovigilance staff
- Safety Reporting
- Documentation
- Clinical Trial Protocol
- Advanced GCP
- GCP for Medical Devices companies
- Informed Consent
- Serious breach and ‘non-compliance’ considerations
- GCP compliance, SOPs and Quality Management Systems
Good Laboratory Practice (GLP) Training Topics
- GLP Training for Study Directors
- GLP Compliance with Multi-site studies
- Advanced Quality Assurance
- Implementing GLP in Your Company
- Advanced GLP
- Introduction to QC
- Sampling Plans
- Microbiology Laboratory Techniques
Good Manufacturing Practice (GMP) Training Topics
- Introduction to GMP
- GMP for Management staff
- GMP International Regulations
- GMP Guidelines
- GMP Audit Preparation
- Recent GMP Updates
- cGMP Auditing – Strategies for Compliance
- GMP Auditor training
Pharmacovigillance Training Topics
- The New EU Pharmacovigilance Legislation
- Pharmacovigilance System Components & Responsibilities
- Pharmacovigilance Inspections
- Safety issues in a typical clinical test
- Risk detection in a clinical research programs
- Adverse Events – Reporting and Regulatory Requirements
- Drug Safety
Bioequivalence Studies Training Topics
- Bioequivalence study of generic
- Bioequivalence study of Biosimilars
- Bioequivalence studies alternative methods
Other General Training Topics
- Medical Devices
- Medical Writing
- Clinical Development: The Clinical Trial Protocol Patient Population
- IATA
- EU Cosmetics Directive No 1223/2009
- Pharmaceutical Drug development
- Designing, conducting and monitoring clinical trial research
- Clinical project management
- Clinical Data Management
- Biostastics , E9 statistical principles for Clinical Trial
- Preparation for an inspection and audits
- Clinical trial protocol
- Clinical monitoring
- Safety monitoring
- Pharmacokinetics
- Computer Systems Validation
- Conducting Clinical Trials in different therapeutics areas and Phases (I-IV):
- Oncology, Cardiovascular, Paediatrics, Haematology, Infectious Diseases, Respiratory Diseases, Digestive Diseases, Biologics (Vaccines, Monoclonal Antibodies etc)
Non-Interventional Study (NIS) Training Topics
- Differences between interventional and non-interventional studies
- Guidance to the country-specific considerations for conducting NIS in Europe, South America, US, Canada, South Africa, Russia, India and Australia
- Data protection and privacy
- Use of human tissue in NIS studies
- Biobanking
- DNA analysis and consent requirements
Human Tissue Research Training Topics
- Use of human tissue
- Biobanking
- DNA analysis and consent requirements
