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The Company SAFETY OBSERVER operates, UNDER THE TRADEMARK SAFETY OBSERVER, a monthly information bulletin of regulatory monitoring and pharmacovigilance for drug safety professionals called « SAFETY OBSERVER », available on the website
The general contractual terms and conditions apply to the visits of the present website by any users, simply accessing this website being considered as an acceptance of the terms herein concerning the use of the website, as well as all the contracts entered into by the Company SAFETY OBSERVER with other contracting parties wishing to buy one or several issues of the « SAFETY OBSERVER » information bulletin or to subscribe to the said information bulletin.
The general contractual terms and conditions herein are at the users’ disposal on the Company SAFETY OBSERVER website where they can be directly read, at any time, and may be also provided on simple request. They constitute the sole basis of the trade negotiation and prevail on the general contractual terms and conditions of the other contracting party, unless otherwise formally accepted in writing by the Company SAFETY OBSERVER. However, special conditions may be granted.
The Company SAFETY OBSERVER is free to change its general conditions of use at any time. It is advised to any users or clients to refer regularly to the last version of the general terms and conditions. In the event of any change, the applicable terms and conditions are those in force on the day of the visit of the website by the user or on the day of the order confirmation by the client.


The « SAFETY OBSERVER » information bulletin is written in English. It gathers information coming from international laws and/or regulations, issued by the European Union as well as from the United States, the United Kingdom and France aimed at drug safety professionals. This bulletin may contain information relating to laws and/or regulations of other countries if the Company SAFETY OBSERVER considers its clients should be made aware.
The « SAFETY OBSERVER » information bulletin gathers the information available in French or in English and mainly the information available on the following institutions’ websites: ICH, CIOMS, WHO, EMA, European Commission, FDA, MHRA, ANSM.
The Company SAFETY OBSERVER issues eleven issues of the « SAFETY OBSERVER » information bulletin a year, a double issue being produced in September to cover the months of July and August.


The users can buy one or several issues of « SAFETY OBSERVER » or buy a subscription to the said bulletin. Each of the options is detailed by a description of its essential characteristics.

3.1 Conclusion of the sales contract

The purchase of one or several issues or a subscription is as follows :
a- connection of the users to their personal account through the use of the username and password defined by the users when creating their account. When creating their account, the users commit to providing accurate and complete information, and to update it without delay. Assuming that the users would provide wrong, outdated or incomplete information, the Company SAFETY OBSERVER reserves the right to suspend or forbid the access to all or part of the website. Concerning the username and the password chosen by the users, they are personal and confidential. The users can modify them online at any time. The change of their username or password will invalidate their prior username or
password automatically. The users are entirely responsible for the use of their access credentials. Any connection to the website or data transfer made from the users’ account will be deemed to be done by the users. The users commit to keeping secret their access credentials and undertake not to reveal them in whatever form to any third party. If access credentials are lost, stolen or accidentally divulged, the users must change them without delay. If access credentials are lost, stolen, misused or used without authorization, the users assume the entire responsibility. If the password is forgotten, the Company SAFETY OBSERVER provides to the users a system to obtain a new password as soon as possible, by e-mail.
b- The users select one or several options.
c- The users validate their order after checking their selection, then they can see the detail of the order as well as the total amount and correct possible mistakes.
d- The users select the method of payment for their order.
e- The users confirm their order and payment. This confirmation results in the conclusion of the sales contract and acceptance of the present general contractual terms and conditions in force at the date of the order, recognition of complete comprehension and a disclaimer with regards to other contractual conditions. The Company SAFETY OBSERVER ensures the conservation and the reproduction of the general contractual terms and conditions applicable pursuant to Article 1369-4 of the Civil Code. The data collected in their entirety and the confirmation of the order are saved on a reliable and durable backup media and by the Company SAFETY OBSERVER and can be saved by the client. They stand as proof of the transaction.

3.2 Communication of the confirmation of the order

The Company SAFETY OBSERVER communicates without delay the confirmation of the stored order, via an e-mail sent to the address given by the clients when creating their personal account. This confirmation of order details the information communicated by the clients in its entirety with, if applicable, any difficulties or reservations relating thereto as well as the reference number of the order given by the Company SAFETY OBSERVER.

3.3 Modification of the order

Any change of the order made by the clients after confirming their order is subject to acceptance by the Company SAFETY OBSERVER. For any question concerning the order tracking, the client can call +33 676 23 20 48.

3.4 Subscription

The subscription is valid for a limited time. The clients will have to renew it from the website to ensure continuity of service. The client will be contacted by the Company SAFETY OBSERVER approximately one month before the end of their subscription in order to remind them that they have to renew their subscription to avoid any service interruption.


4.1 Amount

The issues of « SAFETY OBSERVER » information bulletin as well as the subscriptions to the said bulletin are sold at the price in force at the time of the order. The prices are indicated in Euros and exclude taxes. If the clients are established outside of France, the possible additional rights and taxes will be under their entire responsibility whatever the amount of the order. The Company SAFETY OBSERVER reserves the right to modify its prices at any time but commits to applying the prices in force at the date of the order.

4.2 Terms of payment

The price is payable by credit card, check or bank transfer at the choice of the customer.
Online payment is made through a secure system allowing to encrypt the banking data transmission. The clients must enter their banking details in the right place and confirm the entry. The Company SAFETY OBSERVER reserves the right to verify the data communicated by the client and adopt all the necessary measures for this verification. The Company SAFETY OBSERVER may give formal notice to the client to justify their identity. The failure by the client to answer this request within three calendar days will automatically result in the cancellation of the sale. The Company SAFETY OBSERVER won’t keep any credit card number.

4.3 Payment delays or failure

Pursuant to Article L.441-6 of the Commercial Code, any amount not paid at its due date will result automatically in the application of penalties of an amount equal to ten times the legal interest rate and a fixed allowance for recovery costs of an amount of 40 €. In the event of payment failure within a fortnight after a formal notice remained unsuccessful and sent by e-mail, fax or registered letter, the contract will be either suspended or terminated automatically without judicial intervention, if the Company SAFETY OBSERVER sees fit. The Company SAFETY OBSERVER will retain the sums already paid by the client as damages.


The bulletins bought on the website are sent to the clients by e-mail, to the address given on their personal account, in PDF format. The use of the information bulletin is strictly reserved to the number of users indicated by the client when purchasing. In case of a multi-users subscription, the client is responsible for the distribution to the authorized users. It is strictly prohibited to communicate a copy of the information bulletin « SAFETY OBSERVER », whatever the medium used, to a person other than the authorized users. Non-compliance with this prohibition by the client, within a fortnight after a formal notice remained unsuccessful, sent by e-mail, fax or registered letter, will automatically terminate the contract without judicial intervention if the Company SAFETY OBSERVER sees fit, without prejudice to the damages to which it could be entitled. The Company SAFETY OBSERVER will retain the sums already paid by the client as damages.
Concerning subscriptions, the Company SAFETY OBSERVER uses its best efforts to send the bulletin at the latest on the 10th of each month. However, this is only a mere indication and non-compliance will not in any case engage the liability of the Company SAFETY OBSERVER or justify a modification or a cancellation of an order.


The obligations of the Company SAFETY OBSERVER are obligations of means. The Company SAFETY OBSERVER commits to collecting and compiling very carefully the information object of the bulletin « SAFETY OBSERVER » but cannot be held responsible for any mistake, omission or inaccuracy contained in the documents or websites used to make this compilation.
In any event, if the contractual liability of the Company SAFETY OBSERVER would be engaged, this liability would be limited to the amount due or paid by the client to the Company SAFETY OBSERVER under the sale contract. This amount is deemed to repair all the damages suffered by the client regardless of their nature.


7.1 Website Access

The website is accessible free of charge to any user having internet access. The costs arising from the equipment (computer, telephone, software, means of telecommunication ...) allowing the website access are payable only by the user, as well as the telecommunication costs arising from their use. The users are solely responsible for the good functioning of their computer equipment as well as their internet access.

7.2 Website Operation

The Company SAFETY OBSERVER has an obligation of means concerning the functioning of the website. As a result, it commits to implementing all the reasonable means at its disposal to secure the access, the consultation and use of the website according to the rules of internet usage.
The website is accessible 24 hours a day, on a 7 days basis except in case of force majeure or in case of an event outside the Company’s control and subject to any breakdowns maintenance operations necessary to the good functioning of the website. The maintenance operations may be made without prior notice to the users. The users have to take all appropriate and useful measures in order to protect their own data and/or software and/or hardware from a risk of contamination by any viruses or other computer infections circulating on the internet, the publisher cannot be held responsible for a possible contamination. Any material downloaded by the users or obtained in any other manner when using the website is at their own risk; the users are solely responsible for any damage suffered by their computer or any loss of data following the download of this material or after visiting the website.

7.3 Cookies

Cookies are small files that a website can place on your computer’s hard disk to subsequently track you through the website. Some personalized services of the website use, for their good functioning, temporary cookies. The time-limit for storing such data in the user’s computer is twelve months from their placement. The users can disable the cookies or delete them by using their browser options. Each browser being different, the users are invited to consult their browser’s operating instructions to set it at their convenience. If their computer is configured to refuse them, access to those services can be difficult, if not impossible.

7.4 Hypertext links

« SAFETY OBSERVER » information bulletin offers hypertext links to other websites. To the extent the Company SAFETY OBSERVER has no influence on the content of these websites, it cannot be held liable for the availability of these resources, neither for their accessibility or their content.


When creating a personal account, the personal data directly or indirectly personal are collected in order to manage the orders and carry out customer loyalty programmes. The personal data processing is essential for processing orders.
In accordance with the French law « informatique et libertés » dated January 6th 1978, as amended, users are entitled to a right to access, change and delete personal data (article 40 of the modified French law « Informatique et Libertés »). In order to exercise that right, users are invited to send an e-mail to the following address : The personal information collected for the website is stored according to the rules provided for by the French law« Informatique et Libertés », and during a period of time justified by the end of its processing. The website is registered with the CNIL under the file n°1761025.


All the elements reproduced or used on the website (trademarks, computer applications, photographs, texts, illustrations, moving images or not, vidéo sequences, sounds, etc.) as well as the information bulletin « SAFETY OBSERVER » are protected under intellectual property. Any reproduction, exploitation, editing or use in any way whatsoever, even partially, of any of these elements is strictly prohibited and exposes its author to legal actions, exclusive of contributions sent by website users (testimonies...), unless prior and express authorization has been obtained from the Company SAFETY OBSERVER.


Throughout the term of the contract concluded with the Company SAFETY OBSERVER, the clients expressly authorizes the Company to show their name and/or their trademark with its logo on the website pages as well as on its commercial documents in order to identify them as clients of « SAFETY OBSERVER ».


Any dispute which may arise between the parties concerning the use of the Company SAFETY OBSERVER website or any contract made and entered into through this website, whether it concerns the validity, the interpretation, the performance or the termination of the said contract, will be under the jurisdiction of the Court where the head office of the Company SAFETY OBSERVER is located. Any dispute will be governed by the French law, excluding the provisions of the Vienna Convention.