Image

Ms Elizabeth Ronk Nelson

President, Senior Consultant
Regulatory Risk Management, LLC

Ms Elizabeth Nelson has more than 21 years of experience in the Clinical Research Industry, specialising in compliance and Quality Assurance. Elizabeth was the Compliance Director with Norton Audit in 2005 and subsequently a Quality Assurance Specialist with West Virginia University in 2008.

As the President and Senior Consultant of Regulatory Risk Management, LLC. in US, Elizabeth is specialised in FDA routine and "for cause" audit using FDA BIMO guidance with optional customized, finding-specific and risk - based training. She is also an expert in conducting independent quality systems and GCP compliance audits and assessments for Clinical Investigators, IRBs, CROs Sponsors and Monitors.

With through knowledge of cGCP (FDA and DHHS/OHRP regulations, guidance documents, and ICH GCP guidelines), Elizabeth is a highly-regarded international consultant and trainer in Africa, Europe, Asia and Caribbean. She specialise in conducting courses in GCP compliance and system audits for clinical trials, quality system regulatory risk assessment for responsible, compliant conduct for research, and developing/implementing protocol implementations, corrective and preventative actions, as well as quality systems improvement plans.

Elizabeth is trained in Biology in West Virginia University, Masters in Public Health and Doctorate in Public Policy Analysis.

 

QUALIFICATIONS

  • Masters: Public Health (2001) West Virginia University School of Medicine
  • Bachelors: Biology (1997) West Virginia University -Morgantown, WV

 

PROFESSIONAL AFFILIATIONS AND COMMITTEES

  • International Trainer, Barnett Educational Services
  • Association of Clinical Research Professionals (ACRP)
  • Drug Information Association (DIA)
  • American Public Health Association (APHA)
  • American Society for Quality (ASQ)
  • Former State Chair, March of Dimes Public Affairs Committee (WV)
  • Appointee, West Virginia Birth Defects Surveillance Advisory Council

Upcoming Courses by Ms. Elizabeth

Advanced Auditing for Good Clinical Practice

Good Clinical Practice, An Advanced View