FRA - Introduction to Regulatory Affairs

FRA – Introduction to Medical Devices

• Medical Devices: Definition & Lifecycle
  • Provide the definition of “medical device”
  • Describe how medical devices are classified
  • Outline the activities within a medical device’s lifecycle phases
  • Discuss different types of medical device marketing authorizations
• Introduction to Regulatory Affairs in the US & Canada
  • Identify the organizations involved in the US and Canadian regulatory system, how they are organized and the products they regulate
  • Recognize the regulatory instruments—acts, regulations and/or guidances — and how they are applied
  • Outline the basic regulatory processes used by FDA and Health Canada
  • Identify peripheral agencies outside FDA and Health Canada involved in governing healthcare products
• Introduction to Regulatory Affairs in the EU
  • Describe the origins of the EU regulatory system
  • Identify the organizations involved in the EU regulatory system
  • Outline the regulatory processes associated with various healthcare products in the EU
  • Distinguish between EU processes for region-wide approval and country-specific approval

FRA – Introduction to Pharmaceuticals

• Pharmaceuticals: Definition & Lifecycle
  • Define basic pharmaceutical terminology
  • Identify the key stages in the pharmaceutical product lifecycle, including nonclinical development, regulation of clinical trials, safety issues, marketing approval applications and postmarketing activities
  • Describe the general regulatory requirements relating to good manufacturing practice and marketing
• Introduction to Regulatory Affairs in the US & Canada
  • Identify the organizations involved in the US and Canadian regulatory system, how they are organized and the products they regulate
  • Recognize the regulatory instruments—acts, regulations and/or guidances — and how they are applied
  • Outline the basic regulatory processes used by FDA and Health Canada
  • Identify peripheral agencies outside FDA and Health Canada involved in governing healthcare products
• Introduction to Regulatory Affairs in the EU
  • Describe the origins of the EU regulatory system
  • Identify the organizations involved in the EU regulatory system
  • Outline the regulatory processes associated with various healthcare products in the EU
  • Distinguish between EU processes for region-wide approval and country-specific approval