Areas of expertise: Health Canada clinical trial regulatory submissions (drugs, biologics & radiopharmaceuticals, devices, natural health products)
Current role: President, LCOA Consulting, LLC
Lori is the President of LCOA Consulting, LLC, a small owner-operator regulatory affairs company and has over 16 years of experience reviewing, and completing, investigator-initiated, industry-sponsored, and third-party Health Canada applications. Lori's regulatory career features collaborations with a number of researchers, large academic institutions, national/international collaborative groups and industry, to assist in filing their regulatory applications in a timely and efficient manner. Over the years, Lori has had outstanding success in obtaining approvals and have established excellent relationships within each of the directorates at Health Canada. That knowledge extends beyond clinical trial applications (CTA) and investigational testing authorizations (ITA), to include the completion of screening clarification requests (SCR), information requests (IR), amendments and notifications, controlled substance applications, single patient CTAs, investigational status assessments (ISA) and basic research applications (BRAP).
In addition, Lori has 10 years of experience as a clinical research associate in the field Cardiology, resulting in a depth of knowledge and expertise in the area of clinical trial design, regulations, and conduct. Lori is enthusiatic about for clinical clincal trial development and regulatory filings, and is looking forward to helping collaborators achieve success in their product development endeavors.