Biotech Regulatory Affairs

Global Institute of Regulatory Affairs
In Pune

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Important information

  • Certificate
  • Pune
  • Duration:
    3 Months
  • When:

The biotechnology regulatory affairs course helps the candidates in understanding the regulatory and policy issues in the field of biotechnology. The course covers the impact of regulatory issues on domestic and international affairs, clinical trials and various aspects of a product's life cycle, GLP & GMP, quality control and assurance, bioethics etc. The course will provide with the skills to comply with biotech/biosimilar submissions. It will also enhance the understanding of global regulations and regulatory procedures. This course addresses the risks associated with biotech products and the consequent interpretations of biotech regulations, exhibiting the critical steps to compliance.

Important information

Where and when

Starts Location Timetable
Prestige Classic BLD - Dwing Off no G4 & 5, CHinchwad station Chinchwad Pune, 411019, Maharashtra, India
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Frequent Asked Questions

¬∑ Qualification

Graduates from life Science fields are eligible to apply.

What you'll learn on the course

Pharmaceutical Regulations
Regulatory Bodies
Non-Clinical and Clinical Development of Biopharmaceuticals
Monoclonal Anti-Bodies
Module 3 (CMC) of Biopharmaceuticals

Teachers and trainers (1)

Global Institute of Regulatory Affairs
Global Institute of Regulatory Affairs
Drug Regulatory Affairs

Course programme

    • Learn how to register your biotech product successfully
    • Know whether document generated is adequate for your dossier submission
    • Clarify & Comply with the regulatory requirements when submitting your dossier
    • Successfully compile manufacturing data into the CTD format
    • Understanding the Clinical and Non-Clinical aspects of Biotech products
    • To become a complete RA professional in Biotech industry
Topics CoveredTop
    • Pharmaceutical Regulations (In general)
    • Regulatory Bodies
    • Regulatory Procedures for Marketing Authorizations (In USA , EU & India)
    • General Requirements for CTD
    • Particulars for Specific product Classes
      • Monoclonal Anti-Bodies
      • Vaccines
      • Blood products
      • ATMP’s
    • Module 3 (CMC) of Biopharmaceuticals
    • Non-Clinical and Clinical Development of Biopharmaceuticals

Who Should ApplyTop

  • Biotech Candidates
  • People working in Pharma & Biotech Industry
  • Candidates Pursuring Studies in Biotechnology, Pharma, & Life Science Field
  • Industry Professional

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