BIRAC-CDSA Regulatory Requirements for Biopharmaceuticals (30th-31st July, 2013)

BIRAC in collaboration with Clinical Development Services Agency (CDSA) is organising a Two Day Regulatory Workshop on “Regulatory Requirements for Biopharmaceuticals – From Science to Commercialization” during 30th-31st July, 2013 at Theatre, Indian Habitat Centre, Lodhi Road, New Delhi.

The proposed workshop brings together the Regulatory Educators from Central Drugs Standard Control Organization (CDSCO), ICMR and Experts from Medical Institutes and various Industries. The goal of this workshop is to provide direct, relevant and valuable information on the key scientific aspects of Biopharmaceuticals including its Regulations in India. The Regulatory Meet will be addressing various issues related to the sector, a few of which are mentioned below:

  • Updates on regulatory developments and guidance in India
  • The technical parameters in the Biopharmaceuticals development process
  • Demystifying the Drugs and Cosmetic Act
  • The format and content of IND submissions, including regulatory and scientific requirements
  • Pre-Clinical and Clinical Needs
  • Biopharmaceuticals Review & Approval Process
  • Real time Experience in Filing and seeking Approvals for Biopharmaceuticals

The tentative agenda of the meet is enclosed. The detailed programme structure will also be uploaded shortly and may be accessed /downloaded for reference.

FACULTY:   The faculty comprises of top level speakers from CDSCO, ICMR, Medical Institution and Industry.

WORKSHOP FORMAT: The proposed workshop will feature several cross-cutting sessions addressing the issues common to biological – biopharmaceuticals as well as individual break-out sessions which focus on the unique issues of filing applications for biological – biopharmaceuticals to the regulatory authority for approval. There will be ample opportunity for Q & A and networking throughout the one and half-day workshop.

WHAT YOU WILL RECEIVE: Each participant will receive the course material for use during the workshop and for future reference, which will comprise of:


  1. A software programme on Indian Drug Regulations
  2. Various applicable Guidelines

REGISTRATIONRegistration is through invitation only. For Registration please contact to below mentioned.

WORKSHOP FEE: There will be no fee for attending the workshop.


  • Our intended Audience will be Small manufacturers (SMEs) of biological – biopharmaceuticals who want to learn about how CDSCO approaches the regulation in India.
  • Stake-Holders from BIRAC and CDSA.


Sonia Gandhi     e mail –      

Tel     +911147744515

Click here to download detailed programme structure


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