Falmouth, Maine April 9, 2015
Smithers Rapra are pleased to announce that the US Food and Drug Administration (FDA) has confirmed their involvement at Extractables and Leachables USA 2015 (E&L USA). Dr Timothy McGovern, ODE Senior Pharmacologist/Toxicologist, FDA will be providing the opening keynote address and providing attendees with the FDA perspective on safety qualification of E&Ls.
Dr McGovern has worked as ODE Senior Pharmacologist/Toxicologist at FDA since December 2013 and prior to five years at Scilucent LLC he was a Supervisory Pharmacologist for 11 years in the Divisions of Pulmonary and Allergy Products, and Anesthetic, Critical Care and Addiction Products at FDA. His presentation will open the 2 day conference program alongside presentations from E&L veteran Dr Daniel Norwood, presenting the USP Strategic Plan, and Diane Paskiet of West Pharmaceuticals on the consideration of materials in early stages of drug product development.
Also confirmed to present on the scientific agenda include GE Healthcare, Leo Pharma, Intertek, Novo Nordisk, Toxikon, Baxter, Leadscope and more. The three day event will feature a pre-conference workshop, poster sessions and 17 individual presentations covering case studies on E&Ls in combination and topical product development, large volume parenteral products, migration modelling and assessment methodologies for E&L strategies.
Smithers Rapra’s annual Extractables and Leachables conferences attract a wide range of delegates and this year’s event is set to be the largest edition of the US event yet, with over 110 delegates anticipated to attend. Already confirmed to attend include representatives from leading pharmaceutical companies Teva Pharmaceuticals, Bristol-Myers Squibb Co, Medtronic, and Eli Lilly & Co, who will also benefit from visiting over 15 exhibitors alongside the educational program, providing services to the pharmaceutical and medical device industry. Exhibiting companies include Waters, SGS, ThermoFisher Scientific, Romar, Toxikon and more.
Dr. Feilden, Director of Chemistry Operations at Smithers Rapra, is also our esteemed workshop leader who will cover an introduction to extractables and leachables, material selection, risk based analysis and extractable and leachable testing on the pre-conference day. Places to this workshop are limited, so organizers recommend securing your place well in advance of the event.
Smithers Rapra is the global leader in rubber, plastics, polymer and composites testing, consulting services, and conferences, training, publications and market reports, focused mainly on the tire, industrial, transportation, consumer and medical industries.
Read more about Smithers Rapra by visiting www.smithersrapra.com
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