CSIR-Central Drug Research Institute, Lucknow, a premier Institute under Council of Scientific and Industrial Research (CSIR), is involved in multidisciplinary R&D programs of both basic and applied nature. CSIR-CDRI is a pioneer biomedical research organization in India and has the infrastructure and expertise to develop a drug from concept to commercialization. In the year 2012, CSIR-CDRI shifted to its state of the art new campus, which has been set up with a vision to serve as a Nodal Center of CSIR in new drug discovery and development.
Conclave - Drug Industry, Medicine, Discovery Research and Regulation
Good Manufacturing Practices : Opportunities and Challenges of (Revised) Schedule M
Saturday, 23 November 2024 9 AM to 5 PM
Common Research and Technology Development Hub, Jointly funded Council of Scientific and Industrial Research (CSIR) and the Department of Scientific and Industrial Research (DSIR) of the Ministry of Science and Technology (MoST)
CSIR-Central Drug Research Institute, Sector 10, Janakipuram Extension, Sitapur Road, Lucknow 226031
MEETING FORMAT
Panels of domain experts will discuss
• Regulatory Rationale for Revisions to Schedule M
• Medical need for stringent regulation of drug manufacturing
• Aligning Academic Drug Research With Stringent Regulation
Experts will state the relevant issues in 30-minute conversations with a Moderator.
Participants will address questions to the Moderator during a coffee break.
The moderator will anonymize and comliile questions.
The Panel will re-assemble and respond to the questions.
Supplementary queries/clarifications will be entertained at the Moderator’s discretion.
A fourth Panel will comprise representatives of micro-, small and medium scale enterprises, CROs, CMOs and Consultants, Moderated by the President, UP Drug Manufacturers’ Association, to express their expectations from the Medical fraternity, Researchers and Regulators.
PANELS
Regulatory Panel
Dr. Rajeev Singh Raghuvanshi, DCG(I)
Mr. SM Gupta, State Licensing and Controlling Authority, UP
Mr. DK Tiwari, Dy. Commissioner UPFSDA
Ms. Urmila Agarwal, Asstt. Commisioner, UPFSDA
Moderator: Dr. Amit Misra, Chief Scientist, CSIR-CDRI
Medical Panel
Dr. Nuzhat Husain, RML Hospital, Lucknow
Dr. Dipyaman Ganguly, IICB, Kolkata (confirmation pending)
Dr. Vimala Venkatesh, KGMU
Dr. Sarman Singh, Director, AVMC&H Puducherry; Moderator.
Academia Panel
Dr. Sanjay Batra, Chief Scientist, CDRI
Prof. Padma Devarajan, ICT Mumbai
Dr. Saman Habib, Chief Scientist, CSIR-CDRI
Dr. Naibedya Chattopadhyay, Chief Scientist, CSIR-CDRI; Moderator
Industry Panel
Dr. Ashok Omray, Mumbai
Mr. T. Srikrishna, Locost, Vadodara
Mr. Hitesh Windlass, Windlass Biotech Ltd. Dehradun
Mr. Vir Anjani Kumar Saxena, President, UPDMA; Moderator.
EXHIBITION
• Form-37 Licensed Drug Testing Lab (DTL) at the CRTDH in CSIR-CDRI
• R&D scale (0.5 to 5kg batch size) GMP-compliant manufacturing capabilities at the CRTDH in CDRI
• Products developed by CDRI and ready for clinical development or licensing.
• Firms interested in showcasing their capabilities,
• CMOs/CROs offering services to manufacturers
• Firms seeking Business- to- Business collaborations
(Stalls will be made available to registered participants at additional charges on ‘first come, first served’ basis)
REGISTRATION AND PARTICIPATION
Registration fees (in-person) : Rs. 2500 +18% GST
Registration fees (web link) : Rs. 1000 +18% GST
Students registration fees : Rs. 1000+18% GST
PLEASE ASK MR. KUSHWAHA IF THE FOLLOWING ARE AVAILABLE BEFORE PAYING
Exhibition stall with 15 A power socket : Rs. 10000 +18% GST
Without power connection : Rs. 5000 +18% GST
Interview Room : Rs. 10000 +18% GST
PLEASE PAY BY TRANSFER TO
Beneficiary : Director, CDRI, Lucknow
Account Number : 30269374557
Bank : State Bank of India
IFSC Code : SBIN0010174
SWIFT Code : SBININBB157
MICR Code : 226002050
.png)
