Safety Observer

Clinical Safety & Pharmacovigilance Intelligence Review

PV Focus is partnering with SUNNIKAN Consulting to provide “Safety Observer”, a service of regulatory review specifically for Pharmacovigilance and Clinical Safety: “Safety Observer” is a Pharmacovigilance regulatory newsletter which is distributed on a monthly basis to provide direct access to all new regulatory requirements and announcements of regulatory actions in the field of Pharmacovigilance and Clinical Drug Safety. This service was launched in March 2005 and it is now used by several hundred Pharmacovigilance professionals world-wide to monitor the constantly changing regulatory requirements.

The purpose of this Regulatory Review service is to capture and communicate information relevant to the management of Pharmacovigilance Systems, and to make it available to our clients through web links to the source of information. Our Regulatory Review covers new and draft regulations or regulatory requirements for Pharmacovigilance and Clinical Drug Safety, as well as other news related to Drug Safety.

“Safety Observer” is the result of the periodic monitoring of various sources of information including, without limitation:

  • ICH
  • CIOMS
  • WHO
  • European Commission
  • EMA
  • FDA
  • MHRA
  • Afssaps

Downloads

A free sample of “Safety Observer” is available for consultation here:

Download (pdf)

Upon request, we will be happy to send you more recent examples of Safety Observer so that you can fully evaluate the value of this service to your organization.

For more information about “Safety Observer”, including pricing, please read the Subscription Form:

Subscription Form (pdf)

To subscribe, please complete the Subscription Form and follow the instructions included.
For queries or further information, please use our Contact Form

Safety Observer “Lite”: The free Pharmacovigilance regulatory newsletter

Based on the Full Edition of Safety Observer, we have prepared this version, which is available to all as a free subscription.

More about Safety Observer “Lite”