clinical research, pharmacy,

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CLINICAL RESEARCH BY Clinwell Kriger Training & Research Institute Agra

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Page 1: Clinical Research, pharmacy,

CLINICAL RESEARCH

BY

Clinwell Kriger Training & Research Institute Agra

Page 2: Clinical Research, pharmacy,

WHAT’S NEXT ?

Page 3: Clinical Research, pharmacy,

B.Pharmacy

Industry6,000/-

Area manager

18-20,000/-

PHARMACY CAREERS

12-15,000/-

MR8-10,000/-

18-20,000/-

Industry12,000/-

Lecturer15-16,000/-

M.Pharmacy2yrs

Professor30 –

35,000 /-

PhD3 - 4yrs

2yrs 2yrs 2yrs

Drug inspector -15,000/-Pharmacist- 10,000/-

GOVERNMENT

Page 4: Clinical Research, pharmacy,

WHAT IS CLINICAL RESEARCH?

systematic study of safety & efficacy of a new pharmaceutical product (drug or device)when it is first time introduced into humans.

• It includes the study of a- New Drug- New Disease- New Technology

Page 5: Clinical Research, pharmacy,

ENTRY OF A NEW DRUG IN TO MARKET

1. New drug development2. Preclinical testing/ animal studies3. IND application filed with FDA4. Clinical trials (phases 1, 2, and 3)5. NDA filed with FDA6. FDA validates and approves drug7. Phase 4

Page 6: Clinical Research, pharmacy,

DRUG DEVELOPMENT PROCESS

Page 7: Clinical Research, pharmacy,

PHARMACIST ROLE IN

CLINICAL RESEARCH

Page 8: Clinical Research, pharmacy,

CAREER GROWTH IN CLINICAL RESEARCH

CRC15-

16,000/-

DATA ENTRY OPERATOR18-20,000/-

PROJECT MANAGER

80-90,000/-

CRA-II35-

40,000/-

CRA-I25,000/-

DATAMANAGER

45-50,000/-

BIOSTATICIAN

75-80,000/-

Page 9: Clinical Research, pharmacy,

PHARMACO VIGILANCE30-40,000/-

REGULATORY OFFICER

40-50,000/-

SAFETY LEAD (Drug Safety Specialist)35-40,000/-

AUDITOR50-60,000/-

RESEARCH OFFICER

1-2 LAKHS / MONTH

SPECIALLY FOR PHARMACY FIELD

Page 10: Clinical Research, pharmacy,

Clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market.

Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and

pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug.

These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use.

•CLINICAL RESEARCH

Page 11: Clinical Research, pharmacy,

CLINICAL RESEARCH-INDIA• India has the largest pool of patients(e.g. the highest number of cancer and diabetes patients are found in India)

• Highly qualified Physicians and Surgeons• Availability of Medical, Pharmacy and Science graduates

• Comparative cost advantage• At present more than 1500 trials going on in India and 4000 trials were registered in 2010

Page 12: Clinical Research, pharmacy,

PHARMA COMPANIES : 325 YEARLY REQUIREMENT

BIOTECH COMPANIES : 240 OF CR PROFESSIONALS

CRO’S : 100 >50,000

MNC’S : 50

GROWTH RATE IN CLINICAL RESEARCH IN INDIA – 30% WITHIN TWO YEARS GOVERNMENT SECTOR IS COMINGABROAD 55,000 CLINICAL TRIALS IN USAGROWTH RATE IN CLINICAL RESEARCH IN ABROAD – 55%

JOB OPPORTUNITIES IN CLINICAL RESEARCH

Page 13: Clinical Research, pharmacy,

• Clinwell kriger training and research institute• Collaboration with Clinwell Research Inc. and Kriger Research Center• Site management organization• Independent ethics committee• Current trials: Phase III trial [cardiac] Phase IV trial [skin burns]

Page 14: Clinical Research, pharmacy,

WHY CKTRI ?

Classroom teaching with direct contact with faculty and staff. Online session for convenient off-hours usage. Hands-on training with live projects. Internship opportunities.PG Diploma has worldwide recognition in the bio-pharmaceutical industry. Our courses are recognized by IBPA, ACRP, APPI and SOCRA. We have an active job placement department

to which all student will have access upon completion.

Page 15: Clinical Research, pharmacy,

•FULL TIME TRAININGFULL TIME TRAINING

Page 16: Clinical Research, pharmacy,

•WEEKEND TRAININGWEEKEND TRAINING

•ONLINE TRAININGONLINE TRAINING

Courses Duration

• Advance Certification Program in Clinical Research 6 months

• Advance Certification Program in Clinical Data Management 6 months

• Advance Certification Program in Clinical Research 3 months

• Advance Certification Program in Clinical Data Management 3 months

• Advance Certification Program in Pharmacovigilance and 3 months Regulatory Affairs

Page 17: Clinical Research, pharmacy,

M.Sc. In Clinical Research + GCP CertificateEligibility: Life Science (B. Sc.), MBBS, BDS ,BAMS, BHMS, B.Pharma, B.PT., B.Sc. & B.tech Biotech

Data Management Program + GCP Certificate

Eligibility: Life Science (Graduates), MBBS, BAMS, BHMS, B.Pharma, BDS, B.PT, and IT background

Quality Assurance Program + GCP, GMP, GLP Certificates

Eligibility: B. Sc., BAMS, BHMS, B.Pharma, BDS, B.PT,B.tech Biotech

Clinical Research Associate + GCP CertificateEligibility: Life Science (B. Sc.), MBBS, BDS ,BAMS, BHMS, B.Pharma, B.PT., B.Sc. & B.tech Biotech

OUR COURSES

Page 18: Clinical Research, pharmacy,

CONTACT USUSA Office:15 Corporate Place South, Suite 333,Piscataway, New Jersey 08854Email: [email protected] AGRA CAMPUS: 3 H R Estate, Bodla-Bichpuri Road, Agra-282010.India

Phone: 0562-6540228 Mobile: 9639008511, 9639008512 Web: www.cktri.org Email: [email protected]