Regulatory Authority Compliance

With more stringent compliance parameters set by the USFDA the quality assurance of pharmaceutical products is ensured. In addition to cGMP, GLP and GCP practices as per the US Federal law pharma products should comply with 21CFR regulations. Also on a regular basis the FDA organizes compliance programs for the pharma industries in program areas like Biologics (CBER), Bioresearch Monitoring (BIMO), Devices/Radiological Health (CDRH), Drugs (CDER), Food and Cosmetics (CFSAN), Veterinary Medicine (CVM). The results of regulatory audits NAI – No Action Indication, VAI – Voluntary Actions Indicated, OAI – Official FDA Action Indicated are also critical to decide by auditors in regards to compliance matters and call for several challenges to overcome by the manufacturers. 

  • Food and Drug Administration (FDA)
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Therapeutic Goods Administration (TGA)
  • Central Drug Standard Control Organization (CDSCO)
  • Health Canada
  • European Medicines Agency (EMEA)

Related Conference of Regulatory Authority Compliance

June 06-07, 2018

International Conference & B2B on Pharma Research and Development

Philadelphia, Pennsylvania, USA
August 20-21, 2018

12th Asian Biologics and Biosimilars Congress

Tokyo, Japan
October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
November 15-16, 2018

14th International Conference on Generic Drugs and Biosimilars

Frankfurt, Germany
September 18-19, 2018

6 th European Biopharma Congress

Amsterdam, Netherlands

Regulatory Authority Compliance Conference Speakers

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