IRA001 – Introduction to Regulatory Affairs




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Course Fee : $860

Duration : 1 Day

Time : 9 AM – 5 PM

This course will introduce Introduction on Health Canada, role of regulatory affairs, regulatory terminologies – DIN, NDS, ANDS, OTC & CTC ,drug discovery timeline, phases of clinical trials, ICH-GCP guidelines and common technical document, NDA / NDS submission, ANDA / ANDS submission, DIN# and NPN#, quality assurance and regulatory affairs and post approval activities. You will have a good understanding of the laws and regulations governing regulatory process. At the end of the course, you will be able to complete the required regulatory documents (i.e. CTA, IND) for the regulatory agency, in order to obtain approval from the government for conducting further studies.

Who should attend?

  • Regulatory Affairs Associate
  • Clinical Research Associate
  • Quality Assurance Associate
  • Consultant
  • Clinical Investigator
  • Compliance Officer
  • Manager and Supervisor

25 Watline Ave, Suite #201, Mississauga, ON, L4Z 2Z1

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