Changes with the report to the art 57 database

The EMA management board has released a communication that from 1 February 2016

December 21, 2015

The EMA management board has released a communication that from 1
February 2016, any changes to the location of the Pharmacovigilance System
Master File (PSMF) and details of the Qualified Person Responsible for
Pharmacovigilance (QPPV) can be reported to the art 57 database and separate
type IA variations do not have to be submitted.

The full announcement can be found by following below link:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/12/news_detail_002451.jsp&mid=WC0b01ac058004d5c1

If you have any question about the art 57 database, or are interested in
the services that Asphalion provides for maintenance, installation and training
of IT tools, or preparation for ISO IDMP, please contact us at [email protected]

Search News & Events

Brexit updates for human use medicinal products approved via MRP/DCP

December 21, 2020

As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.

Javier Febrero Alija – New Regulatory Information Manager

December 17, 2020

Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.

Season’s Greetings

December 17, 2020

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.

Necessary

Always Enabled

Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.

Cookie	Duration	Description
cookielawinfo-checkbox-advertisement	1 year	Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Advertisement" category.
cookielawinfo-checkbox-analytics	1 year	Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Analytics" category.
cookielawinfo-checkbox-necessary	1 year	Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Necessary" category.
cookielawinfo-checkbox-others	1 year	Set by the GDPR Cookie Consent plugin, this cookie stores user consent for cookies in the category "Others".
CookieLawInfoConsent	1 year	CookieYes sets this cookie to record the default button state of the corresponding category and the status of CCPA. It works only in coordination with the primary cookie.
elementor	never	The website's WordPress theme uses this cookie. It allows the website owner to implement or change the website's content in real-time.
viewed_cookie_policy	1 year	The GDPR Cookie Consent plugin sets the cookie to store whether or not the user has consented to use cookies. It does not store any personal data.
wpEmojiSettingsSupports	session	WordPress sets this cookie when a user interacts with emojis on a WordPress site. It helps determine if the user's browser can display emojis properly.

Analytics

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.

Cookie	Duration	Description
_ga	1 year 1 month 4 days	Google Analytics sets this cookie to calculate visitor, session and campaign data and track site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognise unique visitors.
_ga_*	1 year 1 month 4 days	Google Analytics sets this cookie to store and count page views.
_gat_gtag_UA_*	1 minute	Google Analytics sets this cookie to store a unique user ID.
_gid	1 day	Google Analytics sets this cookie to store information on how visitors use a website while also creating an analytics report of the website's performance. Some of the collected data includes the number of visitors, their source, and the pages they visit anonymously.

Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.

Cookie	Duration	Description
VISITOR_INFO1_LIVE	6 months	YouTube sets this cookie to measure bandwidth, determining whether the user gets the new or old player interface.
VISITOR_PRIVACY_METADATA	6 months	YouTube sets this cookie to store the user's cookie consent state for the current domain.
YSC	session	Youtube sets this cookie to track the views of embedded videos on Youtube pages.
yt-remote-connected-devices	never	YouTube sets this cookie to store the user's video preferences using embedded YouTube videos.
yt-remote-device-id	never	YouTube sets this cookie to store the user's video preferences using embedded YouTube videos.
yt.innertube::nextId	never	YouTube sets this cookie to register a unique ID to store data on what videos from YouTube the user has seen.
yt.innertube::requests	never	YouTube sets this cookie to register a unique ID to store data on what videos from YouTube the user has seen.

Others

Functional

About

Team

Partners

CSR

AI Ethic Code

Careers

Changes with the report to the art 57 database

The EMA management board has released a communication that from 1 February 2016

Search

Filter by category

Related news and events

Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

About

Team

Partners

CSR

AI Ethic Code

Careers

Changes with the report to the art 57 database

The EMA management board has released a communication that from 1 February 2016

Search

Filter by category

Related news and events

Brexit updates for human use medicinal products approved via MRP/DCP

Javier Febrero Alija – New Regulatory Information Manager

Season’s Greetings

Schedule a Free Meeting