Stakeholder's link pharmaceutical and medical devices
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STAKEHOLDERS Hospitals Pharmacists Government Regulatory bodies Insurance Companies Doctors
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Stakeholder's link pharmaceutical and medical devices
- 1. Pharma and Medical Device – Link with other stakeholders Group 3 KYHP 2 IS 2
- 3. Types of Stakeholders Internal Manufacturing Marketing R & D Management Legal External Consumers: Patients Patient Families Activists General public Media Competition External Mediators: Prescribers Opinion Leaders Pharmacists Nurses Psychologists External Inputting: Regulators Politicians Reimbursement Funds Suppliers
- 5. Hospitals • Buying Centre for making purchase decisions • Data required to that the device is safe and effective • Other Professionals (Clinical Engineers, Device technicians, device trainers) are also important while designing large medical devices • Building relationships with Post-selling Services Medical Device Companies • Data required from hospitals to clear clinical trials • Buying centre for making fixed price decisions for in-house pharmacy • Data required for post-marketing surveillance of drugs Pharmaceutical Companies
- 7. Doctor As a Stakeholder Quality medicine Decision maker Information provider mediator Doctor Medical Devices companies Patient Pharmaceutical companies
- 8. Pharmaceutical company Distributor Pharmacy/Retailer BP machine Stethoscope Insulin injection Dressings Thermometers Needles, syringes Blood pressure monitors Test kits, e.g. cholesterol test kits, pregnancy test kit Inhalers Glucose meters and test strips MEDICAL DEVICES available in pharmacies Pharmacy
- 9. How does e-pharmacy operates? OPERATING COMPONENTS
- 10. Government as a stakeholder • Restricts the drug sector to protect public safety • Encourages development for safe and effective drugs • Looks after safety, efficacy and compliance • Competitive advantage to large companies • Controls drug prices for affordable healthcare Pharmaceutical Industry • Regulates the investigational use of medical technology • Fiscal measures to promote research, development, manufacturing and import of medical devices • Price control of certain medical devices • Rules for grant of patent and trade mark Medical Device Industry
- 11. REGULATORS
- 12. REGULATORS PHARMACEUTICAL INDUSTRY MEDICAL DEVICES 1) Ministry of Health and Family Welfare 2) Central Drug Standard Control Organization 3) Indian Pharmaceutical Association 4) Drug Technical Advisory Board 5) Indian Pharmacopoeia Commission 6) National Pharmaceutical Pricing Authority 1)Central Drug Standard Control Organization 2)Drug Controller General of India Before Phase 1 IND File FDA After Phase 4 NDA File Design and Development FDA
- 15. Thank You Group 3 Bharati Vyas Praseeda Annadevra Pragyan Parimita Sahoo Shivam Gupta Smriti Srivastava Soham Gorade