Post graduation diploma in Clinical researchRaaj GPRAC
- Post Graduate Diploma
- Distance learning
- Delivery of study materials
Frequent Asked Questions
· What are the objectives of this course?
To provide a sound knowledge and understanding of clinical research. To provide an overview of Pharmaceutical industry in all aspects. To provide ethical principles of Good Clinical Practice. Regulatory aspects, including the Clinical Trials Directive and PDUFA III. Pharmacovigilance planning. To develop interpersonal communication (oral/written) and problem-solving skills relevant to clinical research. To understand Project Management principles. To gain knowledge and understand of the key element and principles of clinical trial design, delivery and analysis. Understanding the principles of GCP and their practical implementation in clinical trials. To learn various stages of clinical research undertaken to monitor safety and side effects during large-scale use.
· Who is it intended for?
Graduate/Post graduate in Science, Pharmacy, and Medicines. Pharmacovigilance Strategy, Clinical research professionals (including CRAs and monitors). Study site personnel including Research Nurses. Personnel involved in Phase 1 study. Professionals from pharmaceutical companies, Contract Research organizations, biotechnology and device companies and Regulatory authorities who wish to gain valuable specialist knowledge and practical skills in clinical research. Personnel involved in Drug safety, risk management, clinical data management, Epidemiologists, Market research, statisticians.
What you'll learn on the course
Teachers and trainers (1)
- Introduction to Clinical profession
- Profession, Role and its importance, Overview of the Pharmaceutical Industry
- Drug Development Process
- Overview, Animal studies, Toxicity studies
- Good Clinical Practice (GCP) -ICH E6:
- Ethical Principles and their origin, ICH Audits and Inspections
- Fundamentals of Monitoring Clinical Trials
- Its role in clinical trials & site management & Data monitoring and Detection of frauds
- Project Management
- Principles, Phases & Risk Management
- Clinical Safety & Pharmacovigilance