Regulatory Intelligence

Fundamental to any compliance activity or program is knowing your regulations.

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ethical interactions within healthcare

  • Promotional interactions, material & activities

  • Meetings, events & hospitality

  • Sponsorship of Healthcare Professionals

  • Fee for service & consulting activities

  • Medical and educational goods & services

  • Donations and Grants in support of healthcare or research

  • Non-interventional studies

  • Samples

  • Prohibition of gifts

  • Conduct of company representatives

  • Training

  • Disclosure & Transparency

  • Inspections & Enforcement

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Research, development & authorisation

  • National/centralised registration procedures

  • Disclosure & Transparency

  • Inspections & Enforcement

  • Good laboratory practice (GLP)

  • Good clinical practice (GCP)

  • Good manufacturing practice (GMP)

  • Pharmacovigilance

  • Sampling & testing

  • Good distribution practice

  • Quality defects & product recall

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Corporate & General Public

  • Privacy & confidentiality

  • Contracts & agreements