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Gary Saner

Information Solutions at Reed Tech Life Sciences

Gary Saner is a leading FDA and EMA submissions pro with 30+ years’ experience. Gary is Sr. Manager of Information Solutions at Reed Tech and co-chair of the HL7 SPL Technical Team. Ask him about:
– Device Regulatory submissions, specializing in Unique Device Identifier (UDI)
– Drug Labeling/Listing submissions and Drug Facility registrations (SPL)
– EMA Product submissions (XEVMPD)
– Document Composition and Publishing using XML

Gary is actively investigating support of IDMP, building on his SPL expertise and experience in creating the Reed Tech XEVMPD Team which prepared and submitted over 6,000 products to EMA’s Extended EudraVigilance Medical Product Dictionary.

He guided the successful launch of Reed Tech’s SaaS product and outsourced service for validating, managing, and submitting Medical Device UDI data in HL7 Structured Product Labeling (SPL) format to the FDA. He continues to provide regulatory and technical support to the sales/marketing, software development, and operations groups. This business activity has submitted over 150,000 SPL documents for over 150 global life sciences customers.

Previously, Gary led the successful launch of Reed Tech’s service for preparation of SPL documents for U.S. Drug Labeling and Listing. He is involved in providing regulatory and technical updates to the software development and operations groups. This business activity has created over 75,000 SPL documents for over 850 global life sciences customers of all types: Human Health Rx and OTC, Biologics/Vaccines, Animal Health, medical gases, homeopathic products, and APIs.

Gary also guided the introduction of additional services related to drug regulatory content including: SPL Submission Service to the FDA via the Electronic Submission Gateway (ESG), Composition and Publishing Service that reuses SPL XML labeling content for manufacturing package inserts and marketing advertisement and promotional material, and SPL-PLR Restructuring Service that migrates/recomposes labeling content to the Physicians Labeling Rule format. He was instrumental in creating a Reed Tech service that repurposes sponsor SPL labeling into a published industry reference manual and introducing two online drug databases based on SPLs downloaded from the NLM DailyMed website. Gary also assisted in creating a Drug Sample Distribution (ACA6004) Service that builds FDA production reports for biologic/vaccine manufacturers.