Good Clinical Practice Skills

• Overview UK GCP
• Overview of GCP
• Update
• Refresher
• Clinical Trial Directive
• GCP for Pharmacovigilance staff

Pharmaceutical Technical Skills

• Understanding the Pharmaceutical Industry/Overview of Drug Development
• Introduction to Clinical Trials
• Understanding Clinical Research
• The Effective CRA/ Clinical Trial Administrator
• Effective Monitoring Visits
• Advanced monitoring/CRA skills
• Clinical Trial Management
• Clinical Research Project Management
• Project Management for Pharmaceutical Professionals
• The Regulation of Clinical Trials
• How to write SOPs
• CAPA (Corrective and preventative action)
• How to prepare for Inspection/Audit
• How to audit clinical trials
• Document Management and Archiving

Management/Personal Development Skills

• Project Management (both technical and people skills)
• Leadership skills – in the pharma industry
• Leading Pharma Teams
• Developing Management skills
• Management tools and techniques
• Strategic Thinking
• Communication Skills
• Train the Pharmaceutical Trainer
• SMART pharma skills – Process Improvement course
• CAPA (Corrective and Preventative Action)
• Time Management for Pharma professionals
• Managing Pressure in the Pharmaceutical Industry

Support staff courses include (both technical and personal development courses)

• Drug Development/Overview of the Pharma industry for support staff
• Clinical Trial Project Support for administrators and secretaries
• Understanding the Pharmaceutical Industry and Clinical Trial Administration
• GCP for support staff
• Proactive skills for administrators, PAs, secretaries and other support staff
• Project Management for support staff
• High Performance Business Skills for administrators, PAs, secretaries and other support staff
• Multi-tasking and Managing Managers for support staff
• Time Management for support staff same course as the one above in Management section

Course assessment etc

• Course evaluation assessment including marking course work
• Course examinations
• Course assessment applicable to real-life job issues
• Feedback to staff
• Financial evaluation of training initiatives

Consultancy

• Preparation for audit and regulatory inspection
• Assistance with responding to audit report findings
• Strategy facilitation
• Training needs analysis
• Training strategy development and implementation
• Course development
• SOP training
• Process improvement and facilitation

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