Dy.Dean's Message of CREMA
Dr. R. S. Nadig
MD (Gen. Med), MD (Com. Med),
DPH DIH DAM (JBIMS)
As one of the emerging markets for outsourced Clinical Drug Development, India has established its prime place as an innovative player much sought after by various Multi national companies, CRO’s and leading sponsors for various phases of clinical research, Clinical data management and Pharmacovigilance activities.
Over the last few years, the Indian advantage of a suitable business environment, enthusiastic human resources with superior technical capabilities and the speed of completion of trials coupled with a conducive regulatory environment has made India a proud contributor and therefore has gained recognition as a lead player in ushering in Clinical Trials Industry as a sunrise Industry. Despite the threat of recession, the year 2008 has seen India emerging as a leader among the Emerging Markets with significant increase in large Phase III trials funded by the Industry.
In view of the increasing demand for global patient enrolment shifting to Asia specially India and China, the paucity of trained Clinical trial professionals, organizations such as CREMA have taken up this laudable task of creating Industry oriented curriculum delivered to carefully selected students by experienced Academicians, expert industry leaders and Management gurus.
The onus of building the right kind of capacity to meet the increasing demand for Clinical Trial professionals lies not only with organizations like CREMA but also calls for a close collaborative approach with the Industry. We at CREMA wish to place on record our deep sense of appreciation for the unstinted support, guidance and constant encouragement offered by the Pharmaceutical Industry, CRO’s and others. It gives us immense pleasure that more than 80% of our students have been recruited from campus interviews by various such organizations even before completing their course”
CREMA aims to create and nurture Clinical trial professionals who during their tenure at our various campuses learn, unlearn and relearn ultimately leading from the front in establishing India as an excellent platform for Clinical Drug Development.
Dr. R. S. Nadig
Dy.Dean
http://www.cremaindia.org/index.php?option=com_content&view=article&id=61&Itemid=57
CREMA - Impact Learning System
CREMA has five pillars of growth which are on the basis of teaching methodology, international collaboration, learning series, industry association & industry endorsed courses.
Teaching Methodology:
CREMA has designed a unique LIFSP (Learning by Industry -Faculty -Student partnership) model that establishes a close relationship between the three entities involved in the process - the student, the faculty and the industry.
LIFSP Model
At CREMA, innovation in teaching and excellence in infrastructure is a constant process. We have devised various teaching tools and methodology to impart training that goes a long way in getting our students ready for the industry. Our motive has always been to ensure our students grow into the
most sought-after professionals.
International Collaboration:
The institute believes in making its courses globally credible through tie-ups with world class institutions. A beginning has been made here with its affiliation with UK-based William Harvey Research Ltd. CREMA has also collaborated with Canada’s Clinical Research International for online programmes.
Learning Series:
The focus here will be on reaching out to the issues of the industry and student community through conferences and training programmes. CREMA has partnered with US-based D. Anderson & Company for organizing conferences on issues affecting the clinical research industry like on patient recruitment & retention. Its Corporate Training Programme (CTP) is focused on revising & upgrading the knowledge of CR professionals in the industry through class room sessions and workshops.
Industry Association:
CREMA believes that various stake holders of the clinical research industry should unite to put across their voices together for the betterment of the industry. CREMA is the only player among training institutes, which is part of Indian Society of Clinical Research (ISCR), an association of leading firms connected with clinical research.
Industry Endorsed Courses:
CREMA has constituted its curriculum after deep consultation with the industry. It believes that curriculum needs to be renewed and upgraded on the basis of industrial priority.
http://www.cremaindia.org/index.php?option=com_content&view=article&id=52&Itemid=45
Faculty team at CREMA
Renowned and experienced names from the Clinical Research industry have come together to form the faculty team at CREMA. These expert minds implement a dynamic mix of lectures, case studies and hands-on learning through tried & tested tools and methods. They not only assist students in developing active interest in the curriculum but also in planning a successful career in Clinical Research.
• Permanent Faculty
• Visiting Faculty
http://www.cremaindia.org/index.php?option=com_content&view=article&id=30&Itemid=29
Thursday, November 26, 2009
About us- CREMA
CREMA aims to educate and equip students and industry professionals by imparting advanced training in Clinical Research. Our focus on the all-important Management module in our courses helps students take on the role of leaders in any organization, anywhere in the world. The emphasis of soft skills is one more initiative to ensure students get a head-start in the competitive industry. While our courses and programmes are designed to empower individual to meet industry demands, they fuel the students’ enthusiasm for higher education and professional training. Our strong relationship with the Pharmaceutical, Healthcare & the Medical fraternity helps us provide intellectual resource to serve the needs of both students and the industry. It also ensures that India
CREMA has four state of art campus in Mumbai, Delhi , Bengaluru and Hyderabad
CREMA’s-Our Mission
CREMA to provide high skill training for Global Leadership to promote Ethical Research & Excellence in Clinical Research
- To establish as a premier Training & Research Institute in Clinical Research and Biomedical Sciences, applying high-quality, innovative approaches in research & teaching
- To provide a favorable educational environment that encourages free exchange of thoughts, new ideas, awareness of responsibility and accountability in professional life
- To nurture quality professionals in order to meet the growing demand of skilled manpower for the Pharma, Healthcare, Life Science, Biomedical industry needs for conducting clinical trials scientifically and ethically
- To include cardinal principles of respect, beneficence and justice towards subjects among the next generation of Clinical Research professionals, so that they not only honor, but also take the concept of Good Clinical Practices (GCP) to higher levels
CREMA’s Corporate Programs
Belief
Optimize individual competence and performance to deliver value to organizations and their customers.
Optimize individual competence and performance to deliver value to organizations and their customers.
Method
Work in partnership with industry to enable participants to stay up-to-date and conversant with prevailing practices and technologies to reach out and respond to the needs of the industry.
Work in partnership with industry to enable participants to stay up-to-date and conversant with prevailing practices and technologies to reach out and respond to the needs of the industry.
Model
Programs
Customized Corporate Training Programs
Customized Corporate Training Programs
- We work in partnership with our clients and design complete solutions
Training on Demand
- For specialized needs of the industry
- Onsite Training option
- Crash Courses
Short Term Programs
- ICH/GCP
- Clinical Investigator’s Training Program
- Pharmacovigilance
- Regulatory Affairs
Wednesday, November 25, 2009
Professor Christoph Thiemermann, CEO, William Harvey Research Limited (WHRL), UK, gives an insight into WHRL's collaboration with CREMA (Clinical Research Education and Management Academy) and more on international research education trends and education in India, in conversation with Arshiya Khan
What was the rationale behind WHRL's tie up with CREMA?
We are into clinical research and also teach medical students. When we were approached by CREMA, we looked at the curriculum and felt that there was a need for the course because none of us involved in clinical research had had formal training. So we were medical directors or XYZ at some pharmacetuical company and followed protocols as set by somebody else, so we had to learn how to do it.
Will this collaboration give any accreditation to CREMA?
No. We will only provide guest lecture faculty to CREMA who are experts in their field. These guest lectures may be from the Queen Mary University, London or from the US or Europe. This will give an international label to the teaching here in India. There may be faculty coming to provide lectures on ethics, somebody who looks after the European Medical Agency etc. As far as accreditation is concerned that's not something that we are talking about today, as it is a very new course.
How will this collaboration progress and what will be the frequency of the lectures?
We are going to be sending two or three people every year for a week at a time to teach at every campus of CREMA i.e at Bangalore, Delhi and Mumbai. But the number will vary as when the number of students goes up, more time will be needed.
What benefits does it give WHRL?
At the moment, there is a financial commitment but any profits that are made would be used to do more research. Before the tie up with CREMA, we spoke to pharma companies if they wanted to work with us in some way. What drew us to CREMA is that CREMA is an Indian standard of teaching.. CREMA will train students and so it gives us the way to contact, or to get in contact with a number of small and large pharma companies in India. And this was our major motivation in tying up with CREMA.
Does WHRL have any other similar tie ups with any other institutions in other countries?
No. In terms of teaching, clinical teaching and clinical trial teaching we are committed to CREMA and that's the only tie up we have. We conduct pre-clinical contract research, we do contract research in any given year with about 20-30 different companies and that's all over the world. We have more biotech companies and also big MNCs like GSK.
What is the reason for choosing India and CREMA?
There is no other organisation in India who offers this type of course in pre-clinical trials. Though there are two other organisations in India doing something on the same lines, we were contacted by CREMA. We got introduced to CREMA through the British Council i.e UKTI office (UK Trade and Industry). We told them of our interest to be involved in the clinical trial teaching arena and after negotiations we finalised the deal.
Will the students trained at CREMA be placed in WHRL's CRO?
There is no definitive agreement. It is not really a CRO in the sense that WHRL doesn't do any clinical trials. We only do pre-clinical trials. So there is no agreement in place that we would take all the students or they will be a part. However if there is a trial going on and a student wishes to come to observe and help in that trial at that time, then it is something that can be definitely thought about.
Has the institution also tied up with any other research institutes or government body, in India or else where in the world? Is there any MoU in the pipeline?
No, this deal is exclusive in a way and we have no intentions of tying up with other organisations in India to do clinical trial teaching.
Is the clinical research industry/education in India different from that of Europe? What are the plus and minuses of the Indian Clinical Research industry in terms of education? How can that be built upon?
I think the question should be turned around. There is no ethical pharma training in Europe and in the absence of one I think we are leading. And in fact we are the only country providing formal training for clinical trials. And unlike in other countries where they have small certificate courses or computer based training and they are certified. In UK it's the ICR (Institute of Clinical Research), UK. In America, the American Clinical Research Professionals (ACRP), conducts small time training programmes or computer based training programmes which are later certified. After having realised the fact that clinical research is booming and there is a new paradigm and new business, we have an advantage here as we specifically train people to have the skills and attitude necessary for clinical research as a profession.
Accreditation is quite difficult as they still have to familiarise themselves with the teaching and the topic which they have not done in the past. So I think accreditation will take place in future. There is also a possibility that CREMA or another body in India could teach in Europe and or have similar courses.
A large number of clinical research training institutes have mushroomed to take full advantage of the predicted boom in the clinical research and trials industry. What will determine which institutes stand the test of time and survive the competition?
We have many fly-by-night operators to start such courses. I think over the last few years, there are very few established institutes and organisations. We have CREMA, ICRI, and ACRP. Others are likely to do tie ups or will probably merge or operate in certain regions, not at an all India level. Secondly, people who will stay in the industry are people who have started with a clear vision and a mission of ensuring that you are at the finishing school. And for people who come from other institutes and wish to be employed with this organisation are those who have missed that finishing touch.
So ideally organisations like CREMA who serve as a medium between the industry and the academia are here to stay.
What are your future plans in terms of evolving new courses, specialisations? Which areas would they be focused on?
We recognise that clinical research is a booming industry. And therefore we went ahead and started with clinical research project management, data management, pharmacovigilance, medical writing and clinical trial supplies management. And all of these are getting to be recognised as separate identities requiring special skills. Therefore we are starting with special courses. But these five streams are the ones that we will focus on before we move on. Since we don't have the benefit of existing US or UK based learning programmes, we will start sharing practices with India and say that this is what we require and then exchange notes with others.
What are the international trends in clinical research education/training?
Internationally also we will be looking at the core areas mentioned above. But, India started its foray into outsourced work doing only medical transcription earlier during 2002-2005. We moved on being a Business Process Outsourcing (BPO) organisation doing minimal value add work till recently. We are now considered and acclaimed for medical writing and pharmacovigilance, a definite value addition - KPO a Knowledge Process Outsourcing organisation
Clinical Research is a sunshine industry that spells an opportunity of 50,000 jobs by 2010 in India alone and more than 2,50,000 jobs globally.
Before each medicine makes it to the market, it has to pass a lengthy approval process in which many Clinical Research Professionals are required. CREMA – Clinical Research Education and Management Academy – is a premier training & research institute in Clinical & Biomedical Sciences.
Friday, October 9, 2009
Post Graduate Diploma in Parttime courses Clinical Research & Regulatory Affairs (PGDCRRA)
1) Post Graduate Diploma in Clinical Research & Regulatory Affairs (PGDCRRA)
About the course:
The PGDCR course at CREMA is a one year weekend course. It focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning.
The CREMA Advantage:
CREMA is not affiliated to any university and is an autonomous body. This status enables us to utilize academic freedom to develop trend-setting educational programmes and pedagogic processes with long-term benefits for all stakeholders. The courses at CREMA are industry driven and have been very uniquely designed keeping in mind the industry requirements. Many renowned industry professionals are members of our Academic Council. They bring in with them years of experience in the corporate world and more so in Clinical Research.
Duration:
PGDCR is a one year part-time course with lectures held every Saturday.
Eligibility:
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic and Veterinary Science.
About the course:
The PGDCR course at CREMA is a one year weekend course. It focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning.
The CREMA Advantage:
CREMA is not affiliated to any university and is an autonomous body. This status enables us to utilize academic freedom to develop trend-setting educational programmes and pedagogic processes with long-term benefits for all stakeholders. The courses at CREMA are industry driven and have been very uniquely designed keeping in mind the industry requirements. Many renowned industry professionals are members of our Academic Council. They bring in with them years of experience in the corporate world and more so in Clinical Research.
Duration:
PGDCR is a one year part-time course with lectures held every Saturday.
Eligibility:
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic and Veterinary Science.
Part Time Courses-Post Graduate Diploma in Drug Development (PGDDD) in CREMA
4) Post Graduate Diploma in Drug Development (PGDDD)
About the course:
This course has been uniquely designed keeping in mind the industry requirements from MBBS doctors. Also based on special requests from MBBS graduates, CREMA has started this 6 months Clinical Research course exclusively dedicated to these graduates with classes only on Sundays. This course will have dedicated modules on regulatory affairs, a crucial aspect of clinical research, Medical Reporting, Pharmacovigilance and Clinical Research.
The CREMA Advantage:
This uniquely designed course for MBBS doctors opens up a plethora of job opportunities for them. After the completion of this course, doctors can get absorbed in the Medical Services, Medical Research, Clinical Research functions, Regulatory, Pharmacovigilance and Medical Writing departments of organizations.
Duration:
This is a 6 months course with lectures held every Sunday.
Eligibility:
MBBS Doctors
About the course:
This course has been uniquely designed keeping in mind the industry requirements from MBBS doctors. Also based on special requests from MBBS graduates, CREMA has started this 6 months Clinical Research course exclusively dedicated to these graduates with classes only on Sundays. This course will have dedicated modules on regulatory affairs, a crucial aspect of clinical research, Medical Reporting, Pharmacovigilance and Clinical Research.
The CREMA Advantage:
This uniquely designed course for MBBS doctors opens up a plethora of job opportunities for them. After the completion of this course, doctors can get absorbed in the Medical Services, Medical Research, Clinical Research functions, Regulatory, Pharmacovigilance and Medical Writing departments of organizations.
Duration:
This is a 6 months course with lectures held every Sunday.
Eligibility:
MBBS Doctors
Part Time Courses-Post Graduate Diploma in Pharmacovigilance (PGDPhV) in CREMA
3) Post Graduate Diploma in Pharmacovigilance (PGDPhV)
About the course:
Pharmacovigilance in concerned with the development of science and regulation in the area of drug safety. It aims at detection, assessment and prevention of adverse effects and other medication related problems. This one year part time course is designed to impart the knowledge of regulatory requirements of drug safety monitoring for various countries, train the students on management of pharmacovigilance projects in an organization, drug safety data development during preclinical and clinical phases of drug development and during post approval period. The PGDPhV course at CREMA covers entire array of topics that are related to pharmacovigilance: Clinical research and ethics, basics of adverse drug reactions, principles of pharmacovigilance and the regulatory perspectives. In addition, this course is divided into two semesters that comprises of both theory and practical sessions having exercises and clinical case assignments. During practical sessions, the students will get hands on experience on pharmacovigilance databases, information resources, coding systems and their applications.
The CREMA Advantage:
CREMA has a team of distinguished academicians as their permanent faculty as well as eminent professionals from the pharmaceutical industry, Clinical Research industry and Data Management organizations. These veterans share their experience and knowledge with our students and help them to become ready professionals for the industry and reach the pinnacle of success.
Duration:
PGDPhV is a one year part-time course with lectures held every Saturday.
Eligibility:
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT.
About the course:
Pharmacovigilance in concerned with the development of science and regulation in the area of drug safety. It aims at detection, assessment and prevention of adverse effects and other medication related problems. This one year part time course is designed to impart the knowledge of regulatory requirements of drug safety monitoring for various countries, train the students on management of pharmacovigilance projects in an organization, drug safety data development during preclinical and clinical phases of drug development and during post approval period. The PGDPhV course at CREMA covers entire array of topics that are related to pharmacovigilance: Clinical research and ethics, basics of adverse drug reactions, principles of pharmacovigilance and the regulatory perspectives. In addition, this course is divided into two semesters that comprises of both theory and practical sessions having exercises and clinical case assignments. During practical sessions, the students will get hands on experience on pharmacovigilance databases, information resources, coding systems and their applications.
The CREMA Advantage:
CREMA has a team of distinguished academicians as their permanent faculty as well as eminent professionals from the pharmaceutical industry, Clinical Research industry and Data Management organizations. These veterans share their experience and knowledge with our students and help them to become ready professionals for the industry and reach the pinnacle of success.
Duration:
PGDPhV is a one year part-time course with lectures held every Saturday.
Eligibility:
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT.
Part Time -Post Graduate Diploma in Clinical Data Management (PGDCDM) in CREMA
2) Post Graduate Diploma in Clinical Data Management (PGDCDM)
About the course:
Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials. This one year part-time course is one of the most comprehensive course on the subject. It includes hands-on training on SAS, Data Management, Coding, Database Designing & Validation Procedure Writing. Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course is divided into two semesters which comprises both theory and practical sessions having workshops, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications like Oracle Clinical and EDC Software.
The CREMA Advantage:
CREMA has a team of distinguished academicians as their permanent faculty as well as eminent professionals from the pharmaceutical industry, Clinical Research industry and Data Management organizations. These veterans share their experience and knowledge with our students and help them to become ready professionals for the industry and reach the pinnacle of success.
Duration:
PGDCDM is a one year part-time course with lectures held every Saturday.
Eligibility:
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT
About the course:
Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials. This one year part-time course is one of the most comprehensive course on the subject. It includes hands-on training on SAS, Data Management, Coding, Database Designing & Validation Procedure Writing. Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course is divided into two semesters which comprises both theory and practical sessions having workshops, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications like Oracle Clinical and EDC Software.
The CREMA Advantage:
CREMA has a team of distinguished academicians as their permanent faculty as well as eminent professionals from the pharmaceutical industry, Clinical Research industry and Data Management organizations. These veterans share their experience and knowledge with our students and help them to become ready professionals for the industry and reach the pinnacle of success.
Duration:
PGDCDM is a one year part-time course with lectures held every Saturday.
Eligibility:
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT
Subscribe to:
Posts (Atom)