Cliniminds, Delhi is organizing two days ICH - GCP WORKSHOP ON CONDUCT & MANAGEMENT OF CLINICAL TRIALS on 18th (Saturday) & 19th (Sunday) Dec 2010 at Delhi.
This workshop has been developed to provide overview of clinical research process with a comprehensive review of ICH GCP, Schedule Y and USFDA CFR 21 and the elements involved in coordinating a clinical trial.
Dates of Workshop : 18th-19th December 2010 (Saturday & Sunday) - Timings : 9 a.m. to 5 p.m.
Workshop Venue : Cliniminds Delhi
Last Date of Registration : 15th December 2010. Limited Seats.
Registration Fee :
Rs.6000/- per person. (Includes Certification, presentations; lunch, snacks and beverages).
10% Corporate Discount for 3 or more bookings.
For Registration & Information Please Contact
Cliniminds Delhi
Dr.Nidhi – +91-9311172560 ; Kamal Shahani-+91-9810068241
C-55 First Floor, Vikas Marg, Preet Vihar, Delhi-110092
Email : info@cliniminds.com; Website: www.cliniminds.com
Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Friday, December 10, 2010
Wednesday, August 25, 2010
Fixed dose combinations will be reduced in india
Since long the battle between pharmaceutical manufacturers and DCGI and FDA is going on for the issue of fixed dose combination of 2 or more drugs. The main issue was these fixed dose combination were marketed without any clinical trials. However the pharma companies were arguing that individual compounds are safe and effective and available in the market since long so the combinations are also safe.
Initially so many irrational combinations was banned by DCGI and now in the line of same, DCGI has issued a guidance for getting marketing approval of the fixed dose combinations. These guidelines apply to manufacture, import and marketing approval of fixed dose combinations as a finished pharmaceutical product considered as new drug as per Rule 122(E) of Drugs and Cosmetics Act & Rules. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further described in the draft to provide a detailed guidance for industry. Finally for such FDCs clinical trials is required to be carried out right from Phase I and in order to get permission for marketing the new drug of such FDCs, along with other required documents.
So now onwards no one can manufacture such fixed dose combinations without any clinical trials data.
Initially so many irrational combinations was banned by DCGI and now in the line of same, DCGI has issued a guidance for getting marketing approval of the fixed dose combinations. These guidelines apply to manufacture, import and marketing approval of fixed dose combinations as a finished pharmaceutical product considered as new drug as per Rule 122(E) of Drugs and Cosmetics Act & Rules. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further described in the draft to provide a detailed guidance for industry. Finally for such FDCs clinical trials is required to be carried out right from Phase I and in order to get permission for marketing the new drug of such FDCs, along with other required documents.
So now onwards no one can manufacture such fixed dose combinations without any clinical trials data.
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