samedan logo
 
 
spacer
home > ict > autumn 2017 > time to listen
PUBLICATIONS
International Clinical Trials

Time to Listen

The new era of 2.0 technologies has welcomed the science
of pharmacovigilance (PV) with increasing interest from
regulatory agencies, pharmaceutical companies, healthcare
providers and patients, who may be seen as the leaders of
this evolution – as consumers of health-related products, the
collective voice of patients is having a significant impact. This
is contemporary to an observed shift from evidence-based
medicine towards real world evidence and observational
studies. In these, a study’s design is more fitted to patient life
than in controlled clinical trials, where eligible participants
must adapt to study settings.

Social media platforms, like Facebook, Twitter, and
Instagram, along with health-related websites and forums,
such as PatientsLikeMe or pharma-sponsored websites,
offer large forums of expression where any health-related
idea or concern may be shared, including adverse events
attributed to medications.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
As Senior Safety Scientist at UBC, Caroline Legendre is responsible for supporting operational PV functions, including client interface, deliverables related to product safety and safety signal detection and assessment. She has 10 years of experience in the global pharmaceutical industry, with expertise in vaccines, pre- and post-marketing PV and pharmacoepidemiology.

Alexis Pinçon is Safety Physician at UBC and responsible for providing medical support to operational PV functions. He completed his medical training at the University of Lyon, France, and received his Master of Public Health from Université Besançon (Franche-Comté) in 2007. He has 10 years’ experience in PV within the pharma industry, primarily focused on vaccines in both clinical development and post-marketing.
spacer
Caroline Legendre
spacer
spacer
spacer
Alexis Pinçon
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Merck Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables


More info >>

White Papers

Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control

Berlinger & Co AG

There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
More info >>

 
Industry Events

ManuPharma 2017

6-7 December 2017, Steigenberger Frankfurter Hof, Frankfurt

Europe's first peer-led pharma event for Heads of Tech Ops, Heads of Manufacturing Ops and Site Leads.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement