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This course is
targeted towards candidates interested in joining the clinical research industry
as Clinical Research Assistants / Associates (CRAs).
Curriculum:
The curriculum is focused on providing basic and practical knowledge on clinical
research & the regulations governing it, coupled with exposure to case studies
and good communication & organizational skills required to conduct clinical
research.
The curriculum is
primarily focused on:
·
Fundamentals of ICH GCP & Ethical
Guidelines governing Clinical Research
·
Clinical Research Regulations
·
Drug Development Process
·
Clinical Study Start-up Activities
·
Clinical Study Monitoring
·
Clinical Study Management and Tracking
·
Clinical Study Close-out
·
Quality Assurance
·
Pharmacovigilance
The course will also cover
basics of:
·
Data
Management and Statistics involved in clinical research
·
Role of
Information Technology in clinical research, including the use of e-CRFs
·
Inter-personal skills & communication skills
Lectures
will be conducted by
prominent industry professionals (listed below), particularly from multinational
Pharmaceutical companies and Clinical Research Organizations and will be
followed by case studies, group discussions and workshops.
The faculty consists of
the following personalities established in the field of Clinical Research.
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Dr. Aamir Shaikh, Director,
Medical Affairs, Pfizer India Ltd.
·
Dr. Aakash Ganju, Director,
Global Clinical Operations, Johnson & Johnson
·
Ms. Aditi Andrade,
Specialist, Global Clinical Quality Assurance, Johnson & Johnson
·
Ms. Andrea Francis, Clinical
Study Manager, Pfizer India Ltd
·
Dr. Arun Nanivadekar,
Consultant
·
Dr. Devjani Dasgupta
·
Ms. Farheen Khan, Project
Manager, Novartis
·
Dr. John Knight, Sr. Medical
Advisor, Benefit-Risk Management, Johnson & Johnson
·
Ms. Maithily Sakpal, i3
Statprobe
·
Ms. Mary Royerr,
Statistician, Pfizer India Ltd.
·
Dr. K. Nayanabhiram, Global
Clinical Operations, Johnson & Johnson
·
Ms. Ranjani Nellore,
President, PharMantra Consulting
·
Mr. Roshan Padbidri, Project
Manager, Novartis
·
Ms. Sandipta Talukdar,
Clinical Project Lead, Quintiles India
·
Mr. Sharad Sharma, Associate
Director, i3 Statprobe
·
Ms. Shehnaz Vakharia,
Consultant, QA & Training
·
Mr. Sourabh De, GCP Manager,
Global Clinical Operations, Johnson & Johnson
·
Ms. Swapnali Raut, Clinical
Study Manager, Pfizer India Ltd.
·
Mr. Tushar Sakpal, Pharmanet
·
Dr. Viraj Rajadhyaksha,
Clinical Study Manager, Pfizer India Ltd.
·
Mr. Yogesh Kadam, TCS
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Course eligibility:
·
Students
with a minimum of bachelor's degree in any biological sciences will be eligible
to apply for the course, however, students with a master’s degree will be given
preference.
·
A maximum of
30 students will be selected for each batch, based on their academic background
and a screening interview.
Structure & evaluation:
The course will be
conducted in the St. Xavier's College campus and will comprise of coursework of
4 hours on Saturdays (2pm – 6pm) and 6 hours on Sundays (9am – 3pm)
for 24 weeks. During the course, students are expected to complete 4-6 hours of
assignments every week. At the end of the course, a written assessment test will
be administered to the students.
All students from each
batch will be recommended for internship positions to the clinical research
industry for a period of 4 months. At the end of the internship, each student
will be asked to submit a report and make a presentation to the group.
Evaluation will be made based on the written test and the presentation, judged
for its content & delivery.
Course Fees:
·
Total:
Rs. 69,000/- cosolidated
(This includes
tuition fees, course materials & handouts, refreshments during lectures,
videoconferencing, as applicable, and lecture room facilities)
How to apply:
Click here to download
application form
Candidates may apply by
filling in the prescribed form available on the web site or at the
treasurers office, and submitting it to the Treasurer, St. Xavier's College,
along with the required documents and payment of an application fee of Rs.
100/-. The last date for receiving application forms is
25th June 2008.
Selection will be based on
a personal interview to be conducted in the first week of July. Selected
candidates would be informed by email and would have to pay the above fee, in
cash or by demand Draft in the name of The Bombay St. Xavier’s College
Society, at the time of admission, to the Treasurer, St. Xavier's College,
Mumbai 400 001. The fee may be paid in 2 installments of Rs. 40,000/- at the
time of admission and the balance in the month of August 2008.
Lectures will commence
from 12th July 2008.
Contact details:
For questions, please send
an email to
x_crg2008@yahoogroups.com
or
Dr. Sheela Donde, Course
Co-ordinator
at (022) 22622799 or
caiuslab@vsnl.com;
sheela.donde@xaviers.edu
or
Ms. Aditi Hazra, Course
Director
at 9870037082 or
aditihaz@gmail.com
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Conducted through the Dept. of
Zoology & Forensic Science, this Program has been
in much demand since its inception in 2004.
The program was initiated by
Dr. Vaman Rao, erstwhile Head of Dept, and Ms. Riva Pocha, (M.S. Forensic
Science, U.S.A.), as an answer to a growing curiosity in the science of crime
scene investigation, and its potential as a viable career option.
Until recently, Forensic
Science was a lesser known discipline heard of only behind the closed doors of the
scientific community, far from the reach of the common man. With the increasing
number of deviant crimes and high profile cases in Indian society today, this
applied science is acquiring an importance as a means to assist in prudent
investigation thereby contributing to a more expectant Criminal Justice System.
Knowledge of ones rights combined with the understanding of how to optimize the
use of evidence at a crime scene ensures justice, even if delayed, will no
longer be denied.
This program
recognizes that Forensic Science is no longer limited to crimes against the
human body or property alone. Today crimes as varied as breaches in IT security & cyber
crime, bank fraud, terrorism and wildlife offences are common place in the
forensic world. Hence the program is constantly improving itself to
provide the latest and most relevant information to the students.
We
provide opportunities to conduct short research projects and field
internships
under our faculty guidance, and our faculty is always ready to assist
with career guidance for the student to pursue a future in forensics. However
we do not provide job
placements.
Activities:
Talegaon
medical college
Duration: Nine months (part time) – June to
May or November - October
Cost: Registration – Rs. 200 Course
fees - Rs. 20,000
Timings: Three evenings a week (Mon-Tues-Wed) or
(Thurs-Fri-Sat) 4.00 - 6.00 pm Lectures & Practicals
Eligibility: Preferably science (biology or
chemistry) background, with a minimum of 60 % in qualifying exam (HSC or
equivalent). Admissions are merit based.
Next Batch: Registration closes June 21, 2008. Classes
begin July 3rd 2008 and will run on the Thu-Fri-Sat schedule.
Further information please contact:
Dr. Pushpa Sinkar (chief coordinator) : Tel - 2262 0662 / 5
Ms. Riva Pocha (Senior Faculty & coordinator) :
riva.pocha@gmail.com
Ms. C. Samyukta (lecturer) : csamyukta@gmail.com
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