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University
of Pune in collaboration with Bioinnovat Research Services Pvt.Ltd. announces
starting of CRCDM Course at Bangalore in June 2008.
1. T John College 88/1 Gottigere, Bannerghatta Road Bangalore 560083 : 21st June 2008
New Pharmaceutical Drugs, biological, herbal and natural remedies, nutraceuticals and probiotic food products, and select cosmetics require drug safety and efficacy testing before they are introduced in the market. This testing for drugs on humans comprises Clinical Trials referred as Phase I, II, III trials prior to market launch of the product & Phase IV after market introduction. The data collected from these trials has to be submitted to the respective health authorities of the countries to seek marketing approval for introduction of the product.
The Drug Controller of India in 2003 introduced GOOD CLINICAL RESEARCH PRACTICES wherein it is mandatory that all the clinical trials conducted in India follow these practices in design, approval collection of subject data. Complete compliance of GCP guidelines in India are required for conduct of clinical trials.
India has one of the largest patient population for most of the diseases with genetic diversity. Availability of highly qualified medical practitioners is attracting conduct of global clinical trials in Indian hospitals and clinical sites since India has implemented GCP as per ICH global standards. It is now possible that the data from conduct of trials in India as per GCP guidelines maybe submitted for approval of the drug in USA, Europe, Japan, etc along with submission to authorities in India. The clinical trial industry is doubling in revenue every 2years and as per Mckinsey estimate India has the potential to become one billion dollar revenue industry.
This high growth has created the mandatory need for more clinical research professionals in GCP for conduct Management of the trials.
Eight batches of
this course have been successfully completed by December 2008 and most of
the students are now working in pharmaceutical, biopharmaceuticals Clinical
Reserach organizations.
Series of workshops had been designed
by Bioinformatics center, University of Pune, together with Synergy Network (I)
pvt ltd. Renowned experts form industry and academics were invited for workshop
and curriculum development meeting. Dr R. A. Mashelkar (DG CSIR), Dr. N. K.
Ganguly (DG ICMR), Dr. Vasantha Muthuswamy (SDDG ICMR) and Dr M. K. Bhan (DBT)
have appreciated the past three workshops on Clinical Research and Clinical Data
Management and the syllabus for certificate courses developed by University of
Pune, Bioinformatics center. Any one of the following minimum
qualifications is required (mandatory) to be eligible: Preference will be given
to those who have work experience in a medical institution, pharmaceutical
company, or Clinical/Research unit. Students applying for the course should note
the eligibility criteria, as they will be responsible if they do not fulfill the
eligibility criteria. Postgraduate degree as given above is required to be
eligible for the course. Please note that graduates from medical, pharmacy,
engineering, veterinary and nursing professions and B.Sc with minimum one-year
relevant industry experience are eligible. But preferences will be given to the
Postgraduate degree holders. Eligible students list will be
announced online and they will be registered only on receipt of completed
registration form accompanied by the required bank draft Admissions will be done
on the basis of merit in educational qualification and experience in the field
of medical sciences, life sciences, data management, & clinical research.
Candidates not selected for current course will be given preference for the next
semester course. Career prospects include
a professional career in Clinical Research industry either as a clinical
investigator, site coordinator in at a hospital conducting clinical
investigations or CRO (Clinical Research Organization).Jobs are also available
in pharmaceutical industry, drug development, medical writing, biostatistics or
as a Manager of Clinical Project, Clinical Research Business Development,
Clinical Operations, Data Management, Regulatory Affairs and Auditing of
Clinical Trials. The CRCDM 6 month weekend course is
useful for: Past students are working
at GSK, PRA International, TCS, I3, STAPROBE, Billcare, Serum Institute ,
Macloeds, Emcure, Reliance Clinical Research Services, Jaslok Hospital, Sanofi
Aventis, Fortis, Apollo Neemans Hospital, Jehangir Hospital, Dinanath Mangeshkar
Hospidtal, Ruby Hospital, Panacea Biotec, etc Bioinnovat Research
Services will provide assistance to the students in finding suitable
placement After completion of course the Participants should be
able to: Have better understanding of Good Clinical
Practice and Standard Operating Procedure for Clinical Research and Clinical
Data Management. Contribute more effectively in their
profession pharmaceutical/ biopharmaceutical companies in drug development,
CROs offering clinical research and clinical data management services, in
bio-IT life science industry, or academic research institution or as clinical
investigators at hospitals/ medical sites conducting trials on
subjects. Support overall clinical trial process
electronically by implementing Electronic Data Capture (EDC) system and
Project Monitoring. Participate in design, conduct and
management of global clinical trials conducted at multicentric sites in India
and Overseas. Have an understanding of evolving
regulatory process standards and practices of ICH GCP in conduct of different
therapeutic trials for preparing the submissions made to the regulatory
authorities for seeking market authorization in India, US, EU, Japan
etc Genesis of the
course (Workshops)
Collaborating and Supporting
Institutions to Bioinformatics Centre, University of Pune
Following
Institutions have supported the department by providing guest speakers for the
International Workshops on CRCDM:
Indian Council of Medical Research (ICMR),
Department of Biotechnology (DBT) & Council of Scientific and Industrial
Research (CSIR), CDISC,USA, SCDM,USA
NARI , NIRRH, NIV, NIPER,
CDRI, Pfizer Ltd, GSK, Astra Zeneca, Lilly, Novartis Glenmark, Ranbaxy, Cipla,
Torrent, Panacea Biotech, Biocon, Serum Research Institute, iGATE Clinical
Research International, ClinInvent Research India Pvt. Ltd. ,Vimta
Labs,Quintiles Technologies (I) Pvt. Ltd, Neeman Medical International, Jubilant
Organosys & Jubilant Clinsys ,Matrix Labs, Seth G. S. Medical college and TN
Medical College & BYL Nair Hospital,Apollo Hospital, Apothecaries (India),
SeerPharma Pvt. Ltd (Singapore & Australia), Guillemot Design Ltd (UK),
Kendle International (UK), MDS Rostrum (UK), Technomark (UK), CDISC (USA),
Targacept Inc (USA) , Metropolis labs , Guilford Pharmaceuticals Inc(USA), ICON
Clinical Research (Singapore), ClinWorld Inc.(India), IBM Software Labs (India),
Tata Consultancy Services (India).
Eligibility
MBBS / B.D.S / B.A.M.S / B.H.M.S / B.E. / B. Tech/
B. Pharmacy / BVSC/ B.Sc. (Nursing)/ MCA/ MBA/ MSc / M.Pharm/ MA (Maths or
Statistics)/ B.Sc Career Prospects
Placement:
Learning outcomes
Post Graduate Certificate course in Clinical Research and Clinical Data Management will be covered in two modules within six months beginning with a foundation in clinical research and followed by data management. Medium of instruction will be English. The course is designed for postgraduates and those working in industry or hospital / clinical sites and is scheduled
on weekends i.e. Saturday and Sunday only.Please Note:
The course does not include any direct trials / experimentation on human or animal subjects.
The practical work will be done by students as assignments during the weekdays at their workplaces. Limited number of computer access will be available at the learning centers.
The students in addition should have their own personal access to internet for assignments, projects and communication.
Teaching Methodology
Theory lectures will be conducted over week ends at the venue by faculty approved by Bioinformatics Centre, University of Pune. Course material will be provided on Compact Discs and through an e-learning system introduced in 2007.
The practical will be done by students in form of assignments during the weekdays, as per their convenience, for which they are expected to have independent access to internet.
Projects: Each student will select the topic for his project within eight weeks of joining the course. Thus the projects can be taken by a group of students (not more than 5). Students will send their proposal to Bioinnovat Research Services who will help to nominate the guides. The project should involve about 10 days of research work.
Note: This being a
post graduate certificate course the students are expected to gain knowledge
through interaction with the faculty, use of library /internet and self-study
of course material.
Evaluation and Examination
Students will be
evaluated through periodic internal examination, evaluation of assignment and
project work.
At the end of the course students will appear for final examination conducted
by Bioinformatics center, University of Pune.
Dr. A.S. Kolaskar, ex VC ,Pune and Advisor Knowledge Commission.Faculty for the previous course included the following
Procedure
for Registration:
Please
send the Completed Registration Form downloaded from crcdm.pdf along with demand
draft for Rs. 25,000/- drawn (in favor of Bioinnovat Research Services Pvt.Ltd. Payable at New
Delhi), to the
following address:
Bioinnovat Research Services
Pvt.Ltd,
However final list of selected candidates will be announced online and admission will be confirmed by:
Course Director, CRCDM, Bioinformatics Center, University of Pune, Pune-411007
For exact date of commencement of the course please contact the respective centres.
| Centres | Name | Phone No. |
| T John College 88/1 Gottigere, Bangalore | Mr. Rajesh
Naik, Head-Marketing |
09845148296 |
Email: course@clinicpune.org , bioinnovat@gmail.com, info@tjohncollege.com
Tel: Pune: 020-25690195 / 25692039, Delhi: 011-41354135 Fax: 011-41517277 , Bangalore: 080-28429623/24/25 Fax: 080-28429228
