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Post Graduate diploma in clinical research and Pharmacovigillance

Postgraduate Diploma in Clinical Research and Pharmacovigilance

Program Overview

Our program is designed to provide advanced education and hands-on training for professionals aiming to excel in clinical research and pharmacovigilance. This comprehensive program ensures that graduates are well-prepared for careers in these critical fields.

The Postgraduate Diploma program combines rigorous academic coursework with extensive practical training, enabling participants to develop a deep understanding of clinical research and pharmacovigilance.

Program Objectives

Develop Expertise: Provide in-depth understanding of clinical research
methodologies and regulatory requirements.
Practical Experience: Offer hands-on training at clinical research sites.
Ethical Conduct: Emphasize the importance of ethics in clinical research.
Global Perspective: Equip students with the knowledge to conduct research in diverse, international settings.

Practical Experience: Offer hands-on training at clinical research sites.

- Ethical Conduct: Emphasize the importance of ethics in clinical research.
- Global Perspective: Equip students with the knowledge to conduct research in diverse, international settings.

Pharmacovigilance Module:

- Introduction to Pharmacovigilance: Importance of drug safety monitoring and risk management.
- Adverse Drug Reactions (ADRs): Identification, reporting, and analysis of ADRs.
- Signal Detection and Risk Assessment: Methods for detecting safety signals and assessing risks.
- Pharmacovigilance Regulations: Comprehensive overview of international pharmacovigilance requirements.
- Case Studies and Practical Applications: Real-world examples and hands-on practice.

Key Components

Duration: 12 months
Format: Blended (Online Classes + On-site training)
Timings-9:30am to 5:30 pm
Days- Monday to Saturday

Introduction to Clinical Research
- Fundamentals of clinical research
- History and evolution,
- Current trends

Clinical Trial Design and Management
- Phases of clinical trials
- Protocol development
- Study design and methodology

Regulatory Affairs
- International regulations (FDA, EMA, etc.)
- Good Clinical Practice (GCP)
- Ethics committees and IRBs

Data Management and Biostatistics
- Data collection and management
- Statistical analysis
- Interpretation of results

Ethics in Clinical Research
- Informed consent
- Patient rights and safety
- Ethical dilemmas and case studies

Clinical Research Operations
- Site management
- Monitoring and auditing
- Quality control

Global Clinical Research
- Conducting trials in diverse populations
- Cultural considerations
- International collaborations

On-Site Training 12 Months

Duration: 12 months
Locations: Partner hospitals and research centres

Activities:
- Monitoring clinical trials
- Managing patient data
- Coordinating with research teams
- Reporting and documentation
- Quality assurance practices

Career Opportunities
Graduates of the program can pursue various roles, including:
- Clinical Research Coordinator
- Clinical Trial Manager
- Regulatory Affairs Specialist

Admission Requirements
- Educational Background: Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or related fields.
- Language Proficiency: Proficiency in English & Hindi

Application Process
1. Online Application: Complete the online application form on our website.
2. Supporting Documents: Submit transcript, Photo, Id Proof, Address Proof.
3. Interview: Attend an interview (in-person or virtual) with the admission counsellor.
4. Acceptance: Receive an admission offer and confirm your enrollment.

Fees and Financial Aid
Tuition Fee: 1.5lakh + GST (includes online coursework and on-site training)
Payment Plans: Flexible payment options.