clinical research, pharmacy,
DESCRIPTION
Clinwell Kriger in Pharmacy....TRANSCRIPT
CLINICAL RESEARCH
BY
Clinwell Kriger Training & Research Institute Agra
WHAT’S NEXT ?
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
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
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
DRUG DEVELOPMENT PROCESS
PHARMACIST ROLE IN
CLINICAL RESEARCH
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/-
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
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
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
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
• 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]
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.
•FULL TIME TRAININGFULL TIME TRAINING
•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
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
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]