FDA eCTD-Related News

At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months.  Our users appreciated

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Authors

Kathie Clark

Kathie Clark

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.

kclark@ennov.com

Sean Carpenter

Sean Carpenter

Regulatory expert

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.

Josh Keliher

Josh Keliher

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.

Nic Pillinger

Nic Pillinger

Pharmacovigilance expert

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.

Chet Shemanski

Chet Shemanski

Marketing VP

Chet Shemanski is a proven business and information technology professional with extensive experience serving the healthcare and global life sciences industries.

He has specific expertise in software product commercialization including product management, product marketing, solution strategy, and alliance management.

Chet is a subject matter expert in eClinical and eRegulatory technologies, the author of industry journal articles and a speaker at industry conferences.

Steve Clark

Steve Clark

Regulatory expert

Steve has a Master’s Degree in Immunology from the University of Essex, UK and over 25 years of experience serving in various senior Regulatory Affairs and Regulatory Operations roles for companies including Gilead, Amgen, Merck, Baxter and Parexel.

He is responsible for the implementation of Ennov Regulatory systems and assisting the development of the Ennov Regulatory product suite.