FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov

Kathie Clark | November 13, 2020 | Clinical

Our Speakers

Clinical expert

Kathie is an expert in content management for the pharmaceutical industry, with over 20 years of experience implementing enterprise-level, validated solutions for major life sciences companies in the US, Europe, Japan and Israel. In her prior positions, Kathie was responsible for the design and development of a number of document management products. She is the author of many white papers and blog postings and is a regular presenter at industry conferences. Kathie is also a member of the DIA TMF Reference Model steering committee.

Phillip Strickland

Phillip Strickland is a Clinical Solutions Consultant with Ennov, based in North Carolina, USA. He has over 16 years of experience with the validation/testing, project management and project implementation of various eClinical technologies (EDC, CTMS, ePRO, eTMF, RTSM). You can contact Phillip at pstrickland@ennov.com.

Pharmacovigilance expert


Kristen is a pharmacovigilance expert and holds a Doctorate of Veterinary Medicine, serving as our Executive Sales Consultant. As the Head of the Global PV team for Merial Animal Health, she developed innovative statistical signal detection tools and risk management strategies to support marketed pharmaceutical and biological products worldwide. Kristen brings more than a decade of global PV experience, and is committed to working with customers to develop innovative solutions to meet their compliance and surveillance needs. In her free time, Kristen enjoys spending time with family, training for long-distance races, exploring new recipes,and networking at every opportunity.

Nic Pillinger

Nic has 18 years of experience with pharmacovigilance systems, in the UK and the USA, managing the product range and working with customers to implement and improve operations. As the director of pharmacovigilance products, he ensures that Ennov’s pharmacovigilance offer meets the highest international standards.

Regulatory expert

Josh Keliher has more than 20 years of experience as an expert in Life Science Regulatory, Quality and Clinical (eTMF, CTMS) IT solutions. He has worked for renowned Software Vendors and is currently a senior presales consultant at Ennov.

Sean has over 20 years of experience in delivering Regulatory and Pharmaceutical Record Management solutions for a wide array of large and small Life Science companies. He has experience as a consultant, product owner, business analyst and director of IT for software and services companies, from small start-ups to global multi-national organisations.

Marketing VP

Headquartered in Paris, with offices in Greensboro, NC, Durham, NC and Cambridge, UK, Ennov makes the most cost effective, comprehensive, and user-friendly solutions for regulated content management. We’re proud to serve over 500 customers with a total of 250,000 users, ranging from leading pharmaceutical companies to emerging biotechnology companies throughout the Life Sciences industry.

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