Corporate Etiquette and Soft Skill Training

1. Introduction to LLRI

1. Five must-have skills for every fresher
2. Soft Skills for Career Growth
3. Business Etiquettes
4. SOP standard operating procedures
5. JAM Session (just a minute)
6. Job application

Non-Technical Training

1. Aptitude
2. Communication

Human Anatomy & Physiology

1. An Introduction to the Human Body
2. The Nervous System and Nervous Tissue
3. Anatomy of Central Nervous System
4. The Cardiovascular System: The Heart
5. The Cardiovascular System: Blood Vessels and Circulation
6. The Lymphatic and Immune System
7. The Respiratory System
8. The Urinary System

Pharmacology

1. General Pharmacological Principles
2. Respiratory System Drugs
3. Drugs Acting on Central Nervous System
4. Cardiovascular (CV) Drugs
5. Drugs Acting on Kidney
6. Drugs Affecting Blood and Blood Formation
7. Antimicrobial Drugs
8. Chemotherapy of Neoplastic Diseases

Clinical Research & Ethical Considerations

1. Scope of Clinical Research in India & Global
2. Historical Guidelines in Clinical Research
3. Declaration of Helsinki
4. Ethics
5. Phases of Clinical Trials
6. Introduction to ICH, ICH-GCP Guideline & its advancement
7. Indian Council of Medical Research
8. Drug & Cosmetic Act 1940 & rule 1945
9. Clinical Trial Design
10. Clinical Trial Monitoring

Pharmacovigilance

1. Introduction to Pharmacology and Pharmacovigilance
2. Adverse Drug Reactions and Safety Reports
3. Seriousness & Expectedness & Causality Assessment Criteria
4. Methodologies in Pharmacovigilance
5. Management Systems and Drug Dictionaries in Pharmacovigilance
6. Periodic Safety Update Report (PSUR)
7. Pharmacovigilance Regulations in various countries
8. Pharmacovigilance Programme in India (PVPI)
9. Signal Detection and Data Mining
10. Pharmacovigilance Compliance and Inspections
11. Good Pharmacovigilance Practice (GPP)
12. Pharmacovigilance of Herbal Drugs & Medical Devices
13. Case Study & Hands-on training on Vigisearch, vigiflow
14. Career guide

Clinical Data management

1. Introduction to data management
2. Role and responsibilities of CDM
3. Protocol Implementation
4. CRF/eCRF designing and Workflow
5. Data Base build and validation
6. Data management Plan creation
7. Data Collection & acquisitions
8. CRF tracking
9. Data Entry
10. Data validation
11. Medical Coding
12. QA QC
13. Lab data Management
14. Safety Data Management & Reconciliation
15. Database Lock
16. Data Export/Transfer
17. Reports and data sets
18. Data Archival

Bio-Statistics (Minor Module)

1. Fundamentals of Biostatistics
2. Statistical Tests
3. Survival Analysis

Clinical SAS

1. Introduction to SAS
2. Case Study using SAS

Medical Coding (Minor Module)

1. Medical Terminologies
2. Anatomy & Physiology

Medical Writing

1. Introduction to medical writing
2. Scientific Writing
3. Pre-clinical/Non-Clinical writing
4. Medical Writing for Clinical Trial
5. Medical Writing in the post-marketing phase
6. Guidelines to publish clinical data
7. Medico-marketing writing
8. Medical & Scientific Style guides
9. Data Citation & referencing
10. Plagiarism & Copyright

Regulatory Affairs

1. Introduction to Regulatory Affairs
2. Drug regulatory and accrediting agencies of the worlds
3. Regulatory Document
4. Non-Clinical Study Reports (M4S)
5. Clinical Trials (E3)
6. Provisions related to the Import of Drugs
7. DMF- preparation, submission, responding to regulatory deficiencies
8. Importance of GMP Compliance
9. Orange book
10. Biologics License Application (BLA) and Purple Book
11. QA/QC Documentation
12. Hatch Waxman Act- 180-day exclusivity
13. Patent- Fundamental Concept
14. HIPPA Act

1. Foundations of Clinical Research: Building Soft Skills for Success

2. Navigating Clinical Data Management: An In-Depth Overview

3. Safeguarding Health with Pharmacovigilance Practices

4. Mastering the Art of Medical Writing

5. Professional Conduct: Corporate Etiquettes in Healthcare

6. Sharpening Cognitive Abilities: Aptitude Preparation for Clinical Research

7. Demystifying Regulatory Affairs in Healthcare

8. Preparing for Success: Interview Techniques in Clinical Research

1. Introduction To Clinical Research
2. Soft Skills
3. Clinical Data Management
4. Pharmacovigilance
5. Medical Writing
6. Corporate Etiquettes
7. Aptitude Preparation
8. Regulatory Affairs
9. Interview Preparation