Cliniminds Programs are Certified & Accredited by
Pharmaceutical Society of India
Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance
/
Advanced Post Graduate Diploma in Clinical Research & Regulatory Affairs in Pharma
& Clinical Research
/
Advanced Post Graduate Diploma in Clinical Research & Quality Assurance & Auditing
Why Clinical Research
- Wide Job Horizon
- Attractive Salaries
- Higher Professional Growth
- Global jobs & Training Opportunities
- Higher Job Satisfication
- Need of more than 50,000 trained clinical Research professionals by 2012 (McKinsey)
Why Cliniminds
- Industry recognized courses
- Practical oriented Classes
- Industry experienced faculties
- Video conferencing sessions
- Campus interviews
Key Employers
- Max Neeman International
- Dabur
- CliniRx
- Ranbaxy
- Excel Life Sciences
- Pfizer
- Acccenture
- TCS
- Wipro
- Clinsys
- Fortis
- Novartis & Many More other Companies…
Clinical Research
Drug discovery & development
Ethical Considerations
Clinical Trial Regualtions
Clinical Trial Planning & Management
Submissions & Approvals
Study Start Up Process
Monitoring Essentials
QA & QC
Special Clinical Trials
Practiacal case scenarios
Role plays
Hands on training
Pharmacovigilance(Option 1)
- Overview of Pharmacovigilance
- MedDRA
- Diagnosis And Management of ADR
- Medical Evaluation of Adverse Events
- Expedited Reporting Requirements
- PSURs
- PV Database & Signal Detection Tools
- Risk assessment management
- Exposure to Pharmacovigilance Softwares
Pharma Regulatory Affairs(option 2)
- Pharma Regulatory Practices
- Import and Export of Drugs
- GMP
- QA and Regulations
- Regulations Governing Clinical Trials
- Drug Policies in India
- Orphan Drugs
- Regulations in Pharmaceutical Devices
- TRIPS and Pharma Industry
- IPR Management
- Patent Application
Quality Assurance & Auditing
- Introduction to QA in Clinical Research
- An Overview of Global Regulatory Agencies
- QC in Clinical Research
- SOP Development
- QA Tools-Plans,Policies & CheckLists
- Corrective & Preventive Actions
- Process of Cycle of QA
- Different Types of Audits
- Audit Tools
- Auditors and Conduct of an Audit
- Preparation of an Audit
- Audit Findings and Actions
- FraudMisconduct and Errors
- Case Exercise
- Regualtory Inspections
Cliniminds
326 Galaxy Mall, Opp Ocean Park
Satellite Road,Ahmedabad 380015,Gujarat
Mob : +91-9998704343,+91-9311166940
Tel : +91-079-40308700
Email :
gujarat@cliniminds.com
Website:
www.cliniminds.com
Fee for the Program is Rs100,000 including Laptop with online E-Learning SystemThose
who do not need Laptop, fee would be Rs80,000 payable in 2 instalmentsLimited seats
availableAdmissions ongoing
For free prospectus contact
Mobile: +91-9311166940