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C℞TDH@CDRI

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 by 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


Prior Registration Required!




Calling…

Drug manufacturers
Contract research and manufacturing organizations (CROs/CMOs) and regulatory service providers (Consultants)
Micro-, Small- and Medium-Scale Enterprises
Students (especially of Medicine and Pharmacy)
Academic researchers.

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.


Program

Start Activity Moderator End
9:00 Regulatory Panel Introductory Discussion Dr. Amit Misra 9:30
9:30 Medical Panel Introductory Discussion Dr. Sarman Singh 10:05
10:10 Academia Panel Introductory Discussion Dr. Naibedya Chattopadhyay 10:40
10:45 [Coffee Break], Job Interviews and Exhibition 11:30
11:30 Regulatory Panel Audience Interaction Dr. Amit Misra 12:45
1:00 [Lunch], Job Interviews and Exhibition 2:00
2:00 Medical Panel Audience Interaction Dr. Sarman Singh 3:00
3:00 [Coffee Break], Job Interviews and Exhibition 3:30
3:30 Academia Panel Audience Interaction Dr. Naibedya Chattopadhyay 4:30
4:30 Manufacturers’ Panel Mr. VAK Saksena 5
5:00 High Tea and Closure

Jointly funded by Council of Scientific and Industrial Research (CSIR) and the Department of Scientific and Industrial Research (DSIR) of the Ministry of Science and Technology (MoST)

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)


HR RECRUITMENT OPPORTUNITY

Companies looking for freshers can avail of a limited number of ‘Interview Rooms’ for confidential interview of candidates from the CDRI student body and those attending the Conclave.



REGISTRATION AND PARTICIPATION

Registration deadline: 16:59 PM on 20 November 2024
Registration Form [Link to Google Form]
Contact details Mr. AS Kushwaha, 9140226477; Mon-Fri, 9 AM to 5 PM only
Registration fees (in-person): ₹ 2500 +18% GST
Registration fees (web link) ₹ 1000 +18% GST
Students registration fees: ₹ 1000+18% GST

PLEASE ASK MR. KUSHWAHA IF THE FOLLOWING ARE AVAILABLE BEFORE PAYING

Exhibition stall with 15 A power socket: ₹ 10000 +18% GST
Without power connection: ₹ 5000 +18% GST
Interview Room: ₹ 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

TRANSACTION DETAILS ARE A MANDATORY FIELD IN THE REGISTRATION FORM