GLP in India: Present & Future
GLP Training Program
(13-15 April, 2012)
http://www.niper.gov.in/2012_glp_seminar.pdf
National Institute of Pharmaceutical Education and Research (NIPER)
NIPER
National Institute of Pharmaceutical Education and Research (NIPER) is the first National level institute in pharmaceutical sciences with a proclaimed objective of becoming a centre of excellence for advanced studies and research in pharmaceutical sciences. The Government of India has declared NIPER as an 'Institute of National Importance'. It is an autonomous body set up in a total area of 130 acres under the aegis of Ministry of Chemicals and Fertilizers, Government of India. The institute is conceived to provide leadership in pharmaceutical sciences and related areas as well as toning up the level of pharmaceutical education and research.
ABOUT THE DEPARTMENT
Department of Pharmacology and Toxicology is actively involved in pharmacological and Toxicological Research in the area, viz. Epigenetics and diseases, Diabetes and its complications, Histone modifications as drug target, Toxicant - induced mechanism of Cell-Death, Stroke, Neuropathic pain, Brain ischemia, DNA Damage and Genotoxicity, Chemical susceptibility in pathological models. Department has the potential to conduct toxicity and safety pharmacology screening studies of drug molecules with establishment of National Toxicology Centre (NTC) and National Centre for Safety Pharmacology. More than 200 peer reviewed international publications have resulted since the functioning of the department.
NATIONAL TOXICOLOGY CENTRE (NTC)
Pre-clinical toxicity testing is an integral part of drug safety evaluation. The number of drug failing due to toxicity in pre-clinical testing is in the range of approximately 30% to 40%, making toxicity the number one reason for preclinical attrition. The need of a toxicological facility covering different safety aspects of pharmaceuticals in India was eagerly felt by the drug regulatory authorities as well as by the pharmaceutical industries. Prevention of risk by testing chemicals and to determine their toxic effects depends on the quality of data that are produced in the laboratories engaged in the risk assessment process. Implementation of Good Laboratory Practice (GLP) in toxicity testing facilities in developing countries, especially in India was seen as an urgent issue. In this view the Indian program of GLP certification has already been initiated based on the OECD principles of GLP & compliance monitoring to ensure high quality test data and the mutual acceptance of test results among OECD member countries. NIPER being leading institute in pharmaceutical sciences in India took initiative and set up a toxicological testing facility at NIPER in June, 2005.
The test facility has been approved for the GLP certification by National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology (DST), Govt, of India for conducting toxicity studies and mutagenicity studies. NTC has become the first government centre of the country with GLP certification.
GOOD LABORATORY PRACTICES (GLP) TRAINING PROGRAM
Principles of Good Laboratory Practice (GLP) apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.
This training is organized keeping in view the following audience:
• Personnel working in area of pre-clinical toxicity testing
• Students interested in pursuing career in area of regulatory toxicology
• Personnel interested in GLP training for working in analytical labs
List of Speakers
Dr. Deepak K. Agarwal, Former Scientist 'G', IITR
Dr. Geetha Rajashekhar, Consultant, Qualtox Consultancy
Dr. Girish R. Chaudhary, Head-QA, Ranbaxy
Dr. K.S.Rao, Rao Toxicology Foundation, Bangalore
Dr. P. Balakrishna Murthy, Director, 11 BAT
Dr. Rajendra Hosmani, Syngenta
Dr. S. Natesan, VP & Head- Corporate QA, Advinus
Mr. Satish Murthy, Head- QA, Advinus
REGISTRATION FEE
I) Rs. 3000/-per participant for Govt, personnel
II) Rs 10000/- per participant for industry personnel
III) Rs.2000/- for students
All the students should carry valid student photo identity card and their registration form should be forwarded from their respective HODs.
The registration fee needs to be paid in the form of Demand draft in favor of Director, NIPER payable at Chandigarh/Mohali.
The registration fee includes registration kit, lunch, tea/coffee, breakfast and dinner during training program days and exclude accommodation charges. Limited seats are available on first come first serve basis.
SPONSORSHIP
Company sponsorship fee is Rs. 10,000/- which will allow a small logo in the banner and will be at the back drop of the stage. This sponsorship will allow free registration for one person. In case company wants to have individual banner the cost would be Rs. 20,000/-including free registration for two persons.
ON-SITE REGISTRATION
The on-site registration fee will be charged Rs. 500/-more than normal registration fee for each category.
For Further Correspondence:
National Toxicology Centre Dept of Pharmacology & Toxicology National Institute of Pharmaceutical Education and Research (NIPER),
Sector-67, S.A.S. Nagar -160 062 Punjab, (India)
Ph.: 0172-2214682-87 Telefax: 0172-2214692,2230068 Website: www.niper.gov.in E-mail: ntc@niper.ac.in
GLP Training Program
(13-15 April, 2012)
http://www.niper.gov.in/2012_glp_seminar.pdf
National Institute of Pharmaceutical Education and Research (NIPER)
NIPER
National Institute of Pharmaceutical Education and Research (NIPER) is the first National level institute in pharmaceutical sciences with a proclaimed objective of becoming a centre of excellence for advanced studies and research in pharmaceutical sciences. The Government of India has declared NIPER as an 'Institute of National Importance'. It is an autonomous body set up in a total area of 130 acres under the aegis of Ministry of Chemicals and Fertilizers, Government of India. The institute is conceived to provide leadership in pharmaceutical sciences and related areas as well as toning up the level of pharmaceutical education and research.
ABOUT THE DEPARTMENT
Department of Pharmacology and Toxicology is actively involved in pharmacological and Toxicological Research in the area, viz. Epigenetics and diseases, Diabetes and its complications, Histone modifications as drug target, Toxicant - induced mechanism of Cell-Death, Stroke, Neuropathic pain, Brain ischemia, DNA Damage and Genotoxicity, Chemical susceptibility in pathological models. Department has the potential to conduct toxicity and safety pharmacology screening studies of drug molecules with establishment of National Toxicology Centre (NTC) and National Centre for Safety Pharmacology. More than 200 peer reviewed international publications have resulted since the functioning of the department.
NATIONAL TOXICOLOGY CENTRE (NTC)
Pre-clinical toxicity testing is an integral part of drug safety evaluation. The number of drug failing due to toxicity in pre-clinical testing is in the range of approximately 30% to 40%, making toxicity the number one reason for preclinical attrition. The need of a toxicological facility covering different safety aspects of pharmaceuticals in India was eagerly felt by the drug regulatory authorities as well as by the pharmaceutical industries. Prevention of risk by testing chemicals and to determine their toxic effects depends on the quality of data that are produced in the laboratories engaged in the risk assessment process. Implementation of Good Laboratory Practice (GLP) in toxicity testing facilities in developing countries, especially in India was seen as an urgent issue. In this view the Indian program of GLP certification has already been initiated based on the OECD principles of GLP & compliance monitoring to ensure high quality test data and the mutual acceptance of test results among OECD member countries. NIPER being leading institute in pharmaceutical sciences in India took initiative and set up a toxicological testing facility at NIPER in June, 2005.
The test facility has been approved for the GLP certification by National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology (DST), Govt, of India for conducting toxicity studies and mutagenicity studies. NTC has become the first government centre of the country with GLP certification.
GOOD LABORATORY PRACTICES (GLP) TRAINING PROGRAM
Principles of Good Laboratory Practice (GLP) apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.
This training is organized keeping in view the following audience:
• Personnel working in area of pre-clinical toxicity testing
• Students interested in pursuing career in area of regulatory toxicology
• Personnel interested in GLP training for working in analytical labs
List of Speakers
Dr. Deepak K. Agarwal, Former Scientist 'G', IITR
Dr. Geetha Rajashekhar, Consultant, Qualtox Consultancy
Dr. Girish R. Chaudhary, Head-QA, Ranbaxy
Dr. K.S.Rao, Rao Toxicology Foundation, Bangalore
Dr. P. Balakrishna Murthy, Director, 11 BAT
Dr. Rajendra Hosmani, Syngenta
Dr. S. Natesan, VP & Head- Corporate QA, Advinus
Mr. Satish Murthy, Head- QA, Advinus
REGISTRATION FEE
I) Rs. 3000/-per participant for Govt, personnel
II) Rs 10000/- per participant for industry personnel
III) Rs.2000/- for students
All the students should carry valid student photo identity card and their registration form should be forwarded from their respective HODs.
The registration fee needs to be paid in the form of Demand draft in favor of Director, NIPER payable at Chandigarh/Mohali.
The registration fee includes registration kit, lunch, tea/coffee, breakfast and dinner during training program days and exclude accommodation charges. Limited seats are available on first come first serve basis.
SPONSORSHIP
Company sponsorship fee is Rs. 10,000/- which will allow a small logo in the banner and will be at the back drop of the stage. This sponsorship will allow free registration for one person. In case company wants to have individual banner the cost would be Rs. 20,000/-including free registration for two persons.
ON-SITE REGISTRATION
The on-site registration fee will be charged Rs. 500/-more than normal registration fee for each category.
For Further Correspondence:
National Toxicology Centre Dept of Pharmacology & Toxicology National Institute of Pharmaceutical Education and Research (NIPER),
Sector-67, S.A.S. Nagar -160 062 Punjab, (India)
Ph.: 0172-2214682-87 Telefax: 0172-2214692,2230068 Website: www.niper.gov.in E-mail: ntc@niper.ac.in
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