Programs

Core Curriculum in Clinical Operations

Onboarding

  • Reflective Practice
  • Time Management
  • Study Skills

Data Management and Biostatistics

  • Biostatistics
  • Data Management

Conducting a Trial

  • Investigational Drug Mgt
  • Recruitment Strategies
  • Essential Documents
  • Warning Letters
  • RBM

Working with External Partners

  • Measuring KPIs
  • Identification & Selection of CROs
  • Working with CROs & Sponsors

Introduction to Clinical Operations

  • Clinical Trial Phases
  • Ethical Challenges
  • Informed Consent

Study Design and Protocol Development 

  • Study Design
  • Study Protocol
  • GCP

Project and Financial Management 

  • Work Breakdown Structure
  • Log Frame Matrix
  • Budget Templates
  • Financial Management

Quality Systems, Audits and Inspections

  • SOPs
  • Audits & Inspections

A selection of some of our current, previous and upcoming programs

Previous programs the team at FCD have designed and delivered:

  • M.Sc. Pharmaceutical Medicine as part of Pharmatrain, an EU funded IMI program
  • M.Sc. in Clinical Research with the Medical University of Viena
  • China Course on Drug Development and Clinical Research with Peking University Clinical Research Institute
  • PG Certificate in Drug Development in partnership with DIA
  • PG Certiificate in Clinical Trial Management in partnership with DIA
  • PG Certificate in Regulatory Affairs in partnership with DIA
  • M.Sc Pharmaceutical Medicine with Karolinska Institutet
  • PG Certificates with Karolinska Institutet included:
  • Pharmaceutical Medicine
  • Clinical Trial Management
  • Pharmacometrics
  • Biosimilars and Generics

Current programs include

  • ClinOPs, A multnational Knowledge Transfer Program in partnership with the Global Health Clinical Consortium currently training over 90 investigators, data managers and study coordinators from around the world.
  • Post Graduate Certificate in Clinical Research Operations with the Institute for Global Health at University of Siena.
  • M.Sc in Pharmacy Administration and Policy Regulation with University of Western Cape.
  • PG Certificate in Teaching, Learning and Assessment for university faculty and trainers.
  • PG Certificate in Design and Management of Education and Training programs.

Other PG Certificates include:

  • Introduction to Clinical Operations
  • Data Management and Statistics
  • Clinical Trial Management
  • Project and Financial Management
  • Working with External Partners
  • Quality Systems, Audits and Inspections
  • Biosimilars
  • Regulatory Affairs
  • Pharmacovigilance
  • Health Economics
  • Leadership and Negotiation Skills
  • Ethics

Programs in Development include

  • PG Diploma in Regulatory Affairs
  • Post Graduate DIploma in Global Health Research with The Global Health Network at University of Oxford (pending approval)
  • Capacity Development for Clinical Research Sites
  • Clinical Operations 2.0, which will build on learnings and feedback on our current clin ops courses. Modules will include
    Contract implimentation and management
    Study Design and Protocol Development
    Study Initiation
    Study Close Out

 

For more information please contact info@faculty.ie