POST GRADUATE DIPLOMA IN CLINICAL RESEARCH & PHARMACOVIGILANCE
POST GRADUATE DIPLOMA HEALTHCARE AND HOSPITAL MANAGEMENT
CLINICAL RESEARCH & PHARMACOVIGILANCE
I) TERM 1
1. Introduction to Clinical Research & Pharmacovigilance
2. Basic Sciences
a. Anatomy
b. Physiology
c. Microbiology
3. Pharmaceutical Medicines
a. Pharmacokinetics & Pharmacodynamics
b. Pharmacy & Therapeutics
4. Drug Discovery/ Developments
a. Preclinical Evaluation & Toxicology
b. BA/BE Studies
c. Evolution of New Drugs
5. Ethics in Clinical Research
a. History and Principle
b. Codes
c. Guidelines
d. Vulnerable Populations
e. Insurance & Indemnity
6. Good Manufacturing Practices
7. Pharmacovigilance
a. Introduction to and principles of Pharmacovigilance
b. Adverse Drug Reaction
c. Global Pharmacovigilance
d. Safety standards in Pharmacovigilance
e. MeDRA coding
II) TERM 2
1. Drugs & Cosmetics Act, US FDA, EMEA, Quality, Patents
a. India-DCA
b. US-FDA
c. EU-EMEA
d. Quality
e. Patents
2. Clinical Trial Process
a. SOPs
b. Guidelines
c. Responsibilities
d. Clinical Trials
3. Documentation in Clinical Research
a. Protocol
b. Informed Consent Forms
c. Investigator Brochure
d. Case Record Form
e. Master Files
f. Trial Documents
4. Pharmacovigilance Advanced
a. Regulations & Guidelines
b. Benefit Risk Assessment & Reporting
c. SOPs
d. Setting up a Pharmacovigilance Department
e. Compliance & Inspections of Pharmacovigilance
f. Drug Safety Data Managemente
g. Pharmacovigilance Signal Detection
III) TERM 3
1. Management of Clinical Trials 2. Clinical Trial Budgeting 3. Clinical Data Management 4. Biostatistics in Clinical Trials 5. Audits & Inspections 6. Medical Writing 7. Clinical Research Organisations 8. Life Skills 9. Pharmacovigilance Advanced
i) Effective Communications in Pharmacovigilance
ii) Compliance & Inspections
iii) Pharmacovigilance – Software Solutions
***SEMINARS, CASE STUDIES, PROJECTS, QUIZZES AT THE END OF EACH TERM
HEATLTHCARE & HOSPITAL MANAGEMENT
I) TERM 1
1. Introduction To Healthcare & Hospital Management
a) Concepts of Health & Hospital Management Physiology
2. Management: Principles & Techniques
a) Principles of Management, Tools & Techniques
b) Introduction to Marketing
c) Introduction in Human Resource Management
d) Financial Management
e) Organisational structure & Leadership
SEMINARS, CASE STUDIES, PROJECTS, QUIZZES, WORKSHOPS
II) TERM 2
1. Hospital Management
i) Health Planning, Monitoring, Evaluation & Management
ii) Biostatistics & Research Methodology
iii) Hospital Planning, Designing & Facility Management
iv) Clinical, Diagnostic And Therapeutic Services
v) Hospital Material Management
vi) Hospital Waste Management And Infection Control
III) TERM 3
1. Quality in Hospital / Dissertation
i) Qualtiy Assurance In Hospitals & Healthcare Organisations
ii) Regulations In Hospitals & Heatlhcare
iii) Dissertation Writing
iv) Internship
WORKING SKILLS
Communication, writing, presentation, case study analysis, Interview skills, group discussion, aptitude tests, Conflict management, problem solving, innovation, surviving corporate politics
