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This webinar will cover basic concepts of Investigational Drug Services including legal and regulatory requirements as well as best practices.


  • Understand the role and responsibilities of the principal investigator/designee/pharmacist as part of the clinical trial team
  • Describe clinical trial regulatory requirements and best practices related to investigational pharmacy procedures
  • Understand how the Investigational Plan directs investigational pharmacy operations

  • Regulations governing investigational drugs
  • Pharmacist Role
  • Investigational Drug Services Best Practices

Laws, regulations, and guidelines require tight control of investigational drugs under a clinical trial.  Pharmacists, pharmacy technicians as well as investigators and clinical research professionals wanting to learn about responsibilities for investigational drugs to better comply with regulatory requirements will benefit most from attending this webinar.

  • Investigators
  • Clinical Research Professionals
  • Project Managers
  • Pharmacists
  • Pharmacy Technicians
  • Clinical Trial Monitors
  • Clinical Trial Auditors

Dr. Aurea Flores is a clinical research professional with over 25 years of experience.  She is a licensed pharmacist and was awarded a PhD in Pharmacology & Toxicology with an emphasis in drug metabolism and chemical carcinogenesis.  She has conducted/supported clinical trials in a variety of areas (oncology, cardiology, neurology, and bariatrics) with an emphasis in patient safety, quality, and regulatory compliance. She is a Certified Clinical Research Professional (CCRP-SoCRA), Project Management Professional (PMP-PMI), Agile Project Manager (PMI-ACP), and Certified in Healthcare Research Compliance (CHRC-HCCA), Certified in Healthcare Compliance (CHC-HCCA), Certified in Health Privacy Compliance (CHPC-HCCA), is a Certified Compliance & Ethics Professional (CCEP-SCCE) and is a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP/SQA).   She is a speaker at National meetings and consults in areas of clinical research operations, project management, healthcare and research compliance, and quality assurance.

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