Can Product-Container Interactions Be Reduced? FDA Expert Review Scientist to Discuss at Pharma IQ Conference
On 8th March 2011, FDA Expert Review Scientist, Ingrid Markovic, will discuss how product-container interactions can be reduced when developing new formulation at the Innovation in Pre-Filled Syringes and Injectable Technologies conference.
LONDON, ENGLAND, December 15, 2010
In an article by Direct News, it was stated that: "Focusing on improving pre-filled syringes and single use products is one of the way that the pharmaceutical industry is working to improve their ability to deliver patient safety, but cost of testing continues to be one of the greatest deterrents for developing new products."This clearly marks the timeliness of Ingrid Markovic's session, entitled " Extractables & Leachables In Pre-Filled Syringes," which focuses on regulatory issues from FDA perspective. Attendees are invited to participate in an open discussion with the FDA Expert Review Scientist, with the benefits of getting a comprehensive insight into the different regulatory requirements for pre-filled syringe approval for both new and existing products
The conference, which takes place from 8th-9th March 2011 in Munich, Germany, also offers an interactive panel on achieving patient compliance, featuring Laurence Huxham, Global Head Device Development from Novartis, and Phil Lever, Director from Cambridge Consultants. This ties into several other sessions led by representatives from the pre-filled syringes industry, including:
-A discussion on gaining first time regulatory approval through adequate preparation and understanding regulatory requirements for pre and post registration submissions, led by the Swedish Orphan Biovitrum
-AstraZeneca's perspective on avoiding costly delays and increased toxicity by ensuring the composition of the syringe is compatible with the formulation
-Understanding how to minimise time and cost of development through the application of QbD principles, presented by Francis BioPharma
-Pfizer's session on optimising the fill and finish process for pre-filled syringes
The full agenda, podcast, articles and interviews, are available on http://www.prefilledsyringes.co.uk. The Pre-Filled Syringes event group is open for membership at http://events.linkedin.com/Innovation-Pre-Filled-Syringes/pub/476203
Visit http://www.pharmaiq.com for additional and related content.