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Virtual

Jul 20, 2023 4:00 PM - Jul 20, 2023 5:30 PM

(India Standard Time)

GMP Inspections - Key FDA, EMA & MHRA Updates Applicable to India

Overview

Hear from ex FDA & MHRA Inspectors on the key FDA, EMA & MHRA updates applicable to Indian pharmaceutical manufacturers

Featured topics

  • Inspection approaches, including announced inspections and how regulators assess risk and develop their inspection programs
  • Understand the key challenges in bring new products, including biosimilars to the US market
  • Key inspection findings and be ready to be inspected

Who should attend?

  • Biotechnology
  • Clinical Supplies
  • CMC / Good Manufacturing Practice (GMP)
  • Combination Products
  • Generic Manufacturing
  • Manufacturing: Drug Substance, Drug Prod
  • Outsourcing
  • Quality Control/Quality Assurance
  • Validation

Learning objectives

  • Know the key FDA, EMA and MHRA updates applicable to Indian Pharmaceutical manufacturers
  • Understand regulatory pathways relevant to their site and products

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