CDSCO-IDMA WORKSHOP FOR PROVIDING TRAINING TO MANUFACTURERS

INDIAN DRUG MANUFACTURERS' ASSOCIATION

102B, A Wing,Poonam Chambers, Dr Annie Besant Road, Worli, Mumbai – 400018 INDIA
Tel: +91-22-24944624/24974308 Fax: +91-22-24950723
Email: admin@idmaindia.com / Web: www.idma-assn.org


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CDSCO-IDMA Workshop for providing training to manufacturers on the data requirements for drug product approval under the recent amendments to the Drugs and Cosmetics Rules, 1945 on Saturday, 7th September 2019 at Mumbai

Saturday, 7th September 2019 at Sunville, 9, Dr Annie Besant Rd, Siddharth Nagar, Worli, Mumbai, Maharashtra 400018.


Dear Member,

We are pleased to inform you that the DCG (I) has proposed organizing of Workshops for providing training to the manufacturers on the data requirements for drug product approval under the recent amendments to the Drugs and Cosmetics Rules, 1945. The Workshop will be conducted by CDSCO in collaboration with State Drug Controllers and Pharmaceutical Manufacturers Associations.

The topics will include the following:

  • Regulatory process for grant of product approvals
  • Online submission of applications for grant of additional products.
  • Conduct of BA/BE studies for BCS Class II & BCS Class IV drugs vide G.S.R.327 (E) dt. 03.04.2017 for grant of manufacturing licence of oral dosage form.
  • Submission of data for stability, safety of excipients, etc. vide G.S.R. 360(E) dated 10.04.2018
  • Proposed Revisions in Schedule M and its Implications

Dr P B N Prasad, Deputy DC(I), CDSCO West Zone, Mumbai has requested IDMA Head Office to coordinate in conducting the Workshop. He will also address the participants.

Dr Pallavi Darade, Commissioner, FDA Maharashtra has kindly consented to attend the programme and address the participants.

The Speakers and Faculty will be organised by CDSCO. Senior officers of CDSCO and State Drugs Control Administration will make presentations and will also clarify the queries raised by the manufacturers attending the Workshop. The Agenda is attached for your kind perusal and information.


The Workshop at Mumbai will be held on Saturday, 7 September 2019 at Sunville, 9, Dr Annie Besant Rd, Siddharth Nagar, Worli, Mumbai, Maharashtra 400018


DELEGATE FEES:

IDMA MEMBERS
Rs.1,000/- + GST @ 18%


Group Registration Benefits

  • For every Three (3) Delegates registered from an organisation, the fourth (4) delegate will be complimentary

Due to limited Seats, registration will be on first come-first serve basis. Manufacturing Chemists, Analytical Chemists, Quality Assurance in- charge and Regulatory Affairs personnel may please attend and benefit from the Workshop.



Kindly fill in the Registration Form (attached) and email it back to us along with the payment details.