Small and Medium Pharmaceutical Industry Centre (SMPIC) NIPER-SAS Nagar is organising a one-day interactive session for all manufacturers, regulators and suppliers of pharma industry on 'Common Technical Document' (CTD) on 21st January, 2011 at NIPER compound, Mohali, Chandigarh.
The main aim behind implementing a common format of submission is to make the reviewing of each application more easy and also to avoid omission of critical data or analyses. Omissions of such data can result in unnecessary delays in approvals. CTD not only help in raising the Indian standard but also will help to bring a proper structure to the whole process of filing an application.
The seminar will be attended by Dr Sanjay Jachak, associate professor, Department of Natural Products and in-charge, SMPIC, Dr D Roy, Deputy Drugs Controller, CDSCO (NZ), Ghaziabad, Dr A Panwar, Panacea Biotec, New Delhi, Aprajita Taklar, MD Lark Laboratories India Ltd, New Delhi, Dr Subhash Pande senior vice president, Glenmark Pharmaceutical Ltd., Mumbai and Dr Ajay Prakash, general manager (QA), Win Medicare.
International Conference on Harmonisation (ICH) has developed Common Technical Document (CTD) guidance's for Japan, European Union, and United States. Accordingly most of the countries have adopted CTD format. SMPIC wants to convey the benefits of CTD to all stakeholders for implementing it by sharing information between industries, government, academia and individuals.
The main aim behind implementing a common format of submission is to make the reviewing of each application more easy and also to avoid omission of critical data or analyses. Omissions of such data can result in unnecessary delays in approvals. CTD not only help in raising the Indian standard but also will help to bring a proper structure to the whole process of filing an application.
The seminar will be attended by Dr Sanjay Jachak, associate professor, Department of Natural Products and in-charge, SMPIC, Dr D Roy, Deputy Drugs Controller, CDSCO (NZ), Ghaziabad, Dr A Panwar, Panacea Biotec, New Delhi, Aprajita Taklar, MD Lark Laboratories India Ltd, New Delhi, Dr Subhash Pande senior vice president, Glenmark Pharmaceutical Ltd., Mumbai and Dr Ajay Prakash, general manager (QA), Win Medicare.
International Conference on Harmonisation (ICH) has developed Common Technical Document (CTD) guidance's for Japan, European Union, and United States. Accordingly most of the countries have adopted CTD format. SMPIC wants to convey the benefits of CTD to all stakeholders for implementing it by sharing information between industries, government, academia and individuals.
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