NIPER-S has set up a dedicated Small and Medium Pharmaceutical Industry Centre (SMPIC) to serve SME Pharma sector. The objective of the centre is to help SME Pharma to attain the global standards. SMPIC provides forums where manufacturers, regulators and suppliers can come together to discuss common interest, achievements and new technologies. SMPIC is well-known for its trainings and educational programs.
Furthermore, SMPIC provides fundamental training, job-focused learning and continuous education programs in an open atmosphere allowing frank exchange of information and best practices aimed at reducing costs, improving quality and enhancing marketability. SMPIC intends to organize a seminar on CTD. This workshop will follow an exclusive interactive sessions that shall be very effective and different from other conference lecture styles. SMPIC will provide an impartial setting that fosters sharing of information between industry, government, academia and individuals, thus providing valuable linkages across a wide spectrum of interest in the pharmaceutical industry, in great detail.
ABOUT SEMINAR
• Substantial documentation and data are required for approval of an application to import or manufacture of new drug for marketing, resulting in large, complex applications. Till date. Applicants have used many different approaches in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data oranalyses. Such omission can result in unnecessary delays in approvals.
• The 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.
• The CTD is only format for submission of information. It does not define the content. Applicants many modify the format at some of the sub¬section levels, if needed to provide the best possible presentation of the information, in orderto facilitate the understanding and evaluation.
SEMINAR PROGRAMME 21st JANUARY, 2011
08.30 a.m. 09.00 a.m - Registration
09.00 a.m. 09.05 a.m - Welcome and inauguration of one day seminar on CTD by Dr. Sanjay Jachak, inchange SMPIC.
09.05 a.m 09.15 a.m - Address by Chairman, Consultative Committee-SMPIC.
09.15 a.m.10.45 a.m - Introduction on CTD /ACTD by Dr. D. Roy,
Dy. Drugs Controller, CDSCO (NZ), Ghaziabad 10.45 a.m. 11.00 a.m - Tea
11.00 a.m. 12.30 p.m - Module I & II by Ms. Aprajita Takiar, MD, Lark Laboratories (India) Ltd., New Delhi
12.30 p.m. 02.00 p.m - Module III by Dr. A. Panwar, Panacea Biotech, New Delhi.
02.00 p.m. 03.00 p.m - Lunch
03:00 p.m. 04.30 p.m - Module IV by Dr. Subhash Pande, Sr. Vice President, Glenmark. Pharmaceutical Ltd, Mumbai 04.30 p.m.
04.45 p.m - Tea
04.45 p.m. 06.15 p.m - Module V by Dr. Ajay Prakash, General Manager (OA), Winmedicare 06.15 p.m. 06.30 p.m - Valedictory Session
To receive further details on the Seminar, kindly email at smpic@niper.ac.in with your full mailing address.
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