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Q&A

What is Safety Observer ? 

“Safety Observer” is a service of regulatory review specific to Pharmacovigilance and Clinical Safety for Human Medicinal Products, including Biological Products and Vaccines. Please note that we do not cover announcements related to Medical Devices at this time. 

The newsletter provides a concise summary and direct links to all announcements regarding regulatory requirements and actions in the field of Pharmacovigilance and Clinical Drug Safety. It covers new and draft regulations and guidelines, as well as Product Alerts and more. 

Safety Observer was born in 2005 from a partnership between PV Focus and SUNNIKAN Consulting and the newsletter is received by many users around the world in a range of Pharmaceutical companies. A new company was established in 2013 to administer this service, which remains based on the expertise of the people involved at PV Focus and SUNNIKAN Consulting, two companies that are well known in France and Europe in the field of Pharmacovigilance Quality Assurance and Audits. 

What is the value of Safety Observer ?  

You are a Pharmacovigilance professional working in the industry but you do not have the time to screen alerts and websites to extract relevant regulatory information? Let us do the search for you ! This is a time-consuming exercise that needs to be done. Although some companies have dedicated headcount to provide such Regulatory Intelligence service, Safety Observer offers the possibility to mutualise the costs with other companies, thus bringing significant savings to your company.

What are the sources monitored by Safety Observer ?  

“Safety Observer” is the result of the continuous monitoring of various sources of information including ICH, CIOMS, WHO, European Commission, EMA, FDA, MHRA, ANSM, etc. 

Admittedly, the choice of the sources is influenced by language, and the review is limited to information published in either French or English. “Safety Observer” is the result of a systematic screening of information with an international impact (e.g. ICH, CIOMS, WHO), an impact on the whole of Europe (e.g. EMA, EC), or national impact for the USA, the UK or France. 

This review does not include a systematic screening of information with a national impact for other countries than those mentioned above (e.g. Germany, Spain, Italy, Canada, Australia, etc.). Such information will however be included in case we become aware of relevant announcements through the monitoring of our sources.

How/When is Safety Observer delivered ?

The newsletter is distributed in Adobe PDF format at the frequency of 11 issues a year, which includes a double issue for the months of July/August delivered in September. Every effort is made to deliver Safety Observer before the 10th of the month.

Unless specified otherwise, the delivery will start with the next issue for a new subscription, or with the next issue after your current subscription has expired for a renewal. 

In order to prevent unauthorised distribution, the pdf file includes a watermark indicating the name of the company/subscriber and the number of authorised users covered. 

For multi-user subscriptions, “Safety Observer” is delivered to a single e-mail address (+ one back-up e-mail), as specified by the client. Internal distribution to other end users is the responsibility of the client. We recommend that you set up a group mail box with automatic redirection to your authorized users.

What is the process for renewals ?  

We will get in touch with you at least a month before the end of your running subscription and ask you whether you would like to renew. You will be requested to confirm in writing that you would like to continue the service and a new invoice will be issued.

What payment methods are available ?  

We offer a secure online payment option accepting major Credit Cards (Visa, MasterCard and American Express). In addition, you can also select a payment by check or bank transfer, which must be received within 30 days of the date of your order.