ACROSS Global offers individuals engaged in all aspects of the conduct of clinical trials with a comprehensive range of professional, engaging and practical training courses covering a broad array of topics, including, but not limited to:
a) GxP (e.g., CMC, GCP, GLP, GMP, etc.)
b) Essential Business Skills (e.g., negotiation skills, comunication skills, time management, etc.)
c) Clinical Trial Regulations (e.g., European Medicines Agency (EMA), U.S. Food & Drug Administration (FDA), etc.)
d) Expert Writing Courses (e.g., Risk Assessment Plan, Monitoring Plan, Clinical Development Plan, etc.)
e) Development of Standard Operating Procedures (SOPs) (e.g. for sponsors, service providers, investigational sites, etc.)
Available Clinical Research / GCP related modules include:
- Overview of Drug Development
- Introduction to ICH-GCP E6 – Understanding the Study Cycle
- ICH-GCP E6 R3 – The Coming Changes?
- Ethics Committee & Regulatory Authorities
- Investigator Responsibilities & Oversight
- Informed Consent – The Form, The Process & The Players
- Overview of Pharmacovigilance / Drug Safety
- Investigational Product / Drug Accountability
- Essential Records & Source Documentation
- Subject Recruitment & Retention
- Quality in Clinical Trials
Please request a module / course by clicking on the button ‘Request a Training Course’.
