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AU-KBC Research Centre,
MIT Campus of Anna University,
Chrompet, Chennai-600044.


TRAINING PROGRAMME:"CERTIFICATE COURSE IN CLINICAL RESEARCH"

30th August - 2nd September, 2016 (4 DAYS)

Programme Conducted by:


AU-KBC Research Centre,

MIT Campus, Chromepet,

Chennai -  600 044.

(www.au-kbc.org)

 

         PROGRAMME BACKGROUND

         TOPICS COVERED

         AUDIENCE AND COURSE PLAN

         PAST FACULTY AND ASSOCIATES

         SCHEDULE & REGISTRATION DETAILS

         CONTACT

 

PROGRAMME BACKGROUND

The Indian Pharmaceutical Industry is rated as one of the fastest growing industrial segments not only in India, but also in the global scene. So far the Indian drug industry had its dominance as a supplier of generic drugs for the Indian and global markets. With the advent of the post - 2005 TRIPS compliant patent regime, the Indian industry is moving into the R&D space to meet global challenges for the discovery and development of new drugs. Drug discovery and development involves both extensive pre-clinical and clinical investigations before the products are ready for marketing. Clinical research is one of the most important, complex and expensive components of drug development, which has so far been carried out in India mostly to substantiate and validate already established drugs for the Indian market. In recent times the advantages of setting up Indian organizations for establishing clinical research facilities has been well recognized and a number of Contract Research Organisations (CROs) have come up in India to carry out clinical research not only for products of Indian origin, but also for those originating from the global R&D based pharmaceutical companies.

One of the most important components of clinical research is the conduct of well controlled clinical trials in patients after the candidate drug has been subjected to pre-clinical studies to determine their safety and efficacy in experimental animal models. Due to the availability of large patient populations with diverse disease conditions, cultural variations and variations in dietary habits, skilled clinical investigators and adequate analytical facilities and resources, India offers tremendous possibilities for the successful conduct of clinical trials. Apart from these there are important cost advantages when clinical trials are conducted in India, an important consideration for reducing the overall costs of drug discovery and development - over a quarter of the overall expenditure of developing a new drug from concept to market is estimated to go into this activity alone, and cost saving here can impact significantly on the business prospects.

Because of these reasons, as well as due to the passing of the Amendment to Schedule Y of the Indian Drugs and Cosmetics Act in 2005, the CRO industry is poised for substantial growth in the country. It is estimated that during the next three years the CRO industry in India would be worth about a billion dollars, and the requirement of personnel for the management of clinical trials in India alone could be around 50,000. Given the rather inadequate number of programs as well as facilities presently available for the training of such manpower in India, it is obvious that there is a need for established institutions to come forward to fill the gap and help India leverage this newly emerging global opportunity.

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TOPICS COVERED

Drug discovery process includes stage of basic research, stage of drug development which involves pre-clinical testing, clinical research, and registration with the drug regulatory agency such as FDA and finally introduction of the drug to the public after approval.

  • Good Clinical Practices and Ethics in Clinical Research
  • Brief discussion on pre-clinical trials (In-silico & In-vivo trials)
  • Phases of Clinical Research (Phase I – III)
  • Protocol designing, development and amendments
  • Roles of Investigators, Hospitals and Health Institutions, sponsors in a clinical trial.
  • Role of Independent Ethics Committee/ Institutional Review Board
  • Preparation of Trial reports (Medical writing) and regulatory dossier
  • Pharmacovigilance & Clinical safety
  • Overall management of a clinical trial including fundamentals of monitoring of trials
  • Regulatory Affairs
  • Quality Assurance and Quality auditing practices
  • Good laboratory Practices and Good Documentation Practices
  • Clinical Data Management (CDM)

Note: Please note that there won't be any wet lab experiments

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AUDIENCE AND COURSE PLAN

The workshop is targeted towards Graduate and Post-graduate students in Science, Engineering and Technology / Life Science Scientists / Medicine / Pharma, Bioinformatics and Biotechnology Faculty / PhD scholars / PDF's. The presentation will be in a tutorial style and participant's interaction will be strongly encouraged.

For each topic, bird's eye view will be provided in the beginning and a list of tools and databases used also provided. Important tools in each will be demonstrated with few examples. For all categories, exercise will be given to get hands on experience. Course material will be given in the form of CD to each participant.

Course Plan
The course will be conducted in 8 sessions at the AU-KBC Research Centre, Chromepet from

30th August - 2nd September 2016
(4 days; 32 hrs)

Morning Session - 09:00 AM - 01:00 PM
Afternoon Session - 02:00 PM - 06:00 PM

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PAST FACULTY AND ASSOCIATES

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SCHEDULE AND REGISTRATION DETAILS

The course fee is Rs 4,950/-(Four thousand nine hundred and fifty only). Please send a Cheque / DD drawn in favour of The Director, AU-KBC Research Centre payable at Chennai along with application duly filled.

Last Date for Registration: 25.8.2016. Please note that the number of seats is limited and registration is made on the basis of first come first served.

Participation certificate will be given at the end of the programme.

IMPORTANT NOTE: ALL THE PARTICIPANTS ARE REQUESTED TO BRING THEIR LAPTOPS.

CLICK HERE TO DOWNLOAD THE REGISTRATION FORM

CLICK HERE FOR AU KBC BIOINFORMATICS LAB

Please send your applications along with Cheque / DD to:

The Director,
AU-KBC Research Centre,
MIT Campus, Anna University Chennai, Chromepet,
Chennai - 600 044.

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CONTACT:

Dr. G. Ramesh Kumar,
Course Coordinator, AU-KBC Research Centre,
MIT Campus,Anna University Chennai,Chromepet,
Chennai - 600 044.
Tel: 91-44-22232711 Extn.133,
Fax: 91-44-22232711
E-mail: grameshpub@au-kbc.org
Web site: www.au-kbc.org

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