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PHARMACEUTICAL INDUSTRY EVENTS CALENDAR

10th Annual Summit for Clinical Ops Executives

SCOPE Summit 2019

18-21 February 2019
Hyatt Regency Orlando, Florida

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Artificial Intelligence (AI), Sensors and Wearables, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Biomarker Strategy, Clinical Supply Chain, Precision Medicine, and Biospecimens and Central Lab Solutions.

SCOPE attracted 1,700 leaders in clinical operations and research in 2018 and each of our conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field. www.scopesummit.com

phone 781.972.5400
email chi@healthtech.com
web www.scopesummit.com
email Cambridge Healthtech Institute, 250 First Avenue, Suite 300 Needham, MA 02494
 
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Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test

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Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
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