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Certificate

Professional Regulatory Affairs

Program code:

Credential:

Certificate

Duration:

Delivery Mode:

Online / Onsite / Recorded Program

Start Date(s):

January | May | September
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Program Overview – Professional Regulatory Affairs

Regulatory approval and communication processes are essential to the development, production, and marketing of cannabis, pharmaceutical, biotechnology drugs, natural health products (NHPs), and medical devices. As a result, professionals with specialized training in Professional Regulatory Affairs are in high demand across these industries.

After successful completion of this course, students will be:

  • Able to understand the current regulatory affairs framework
  • Able to prepare for NDA
  • Able to submit NDA
  • Able to perform other regulatory affairs activities

  • International, Health Canada, and FDA’s laws, regulations, and Guidelines
  • Investigational and marketing applications

  • Technical writing, negotiation skills
  • Development of New Drug Application (NDA) submissions
  • Labeling and drug Information

  • Electronic Common Technical Documents (eCTD)
  • Notice of Compliance (NOC)

  • Good Clinical Practices (GCPs)
  • Requirements for ongoing post-marketing surveillance
  • Post-marketing changes, communication and management skills
  • Case study

  • Good Clinical Practices (GCPs)
  • Requirements for ongoing post-marketing surveillance
  • Post-marketing changes, communication and management skills
  • Case study

  • Regulatory Affairs for the cannabis industry
  • Cannabis regulations act
  • Post-marketing changes, communication and management skills

Who Should Attend

Anyone who wants to become the following should attend this webinar on regulatory affairs training:

  • Regulatory Affairs Associate
  • QA Associates
  • Quality Assurance Person (QAP)
  • Regulatory Professionals
  • Regulatory Affairs Associates
  • Regulatory Affairs Coordinators
  • Auditors and Inspectors