FORUM INSTITUT SEMINAR | Updates on EMA Electronic Application Management

The variations submission for human medicines became the first form to be submitted via the PLM portal in November 2022, with other application forms to follow.

March 13, 2023

| Clinical development stage, Data Management, EU, Event, Regulatory Operations: eCTD and Submissions

📆 26 April, 2023 💻 Online course

The Product Lifecycle Management (PLM) portal, which will replace electronic application forms (eAFs) in PDF format for regulatory applications, is intended to make filling in forms and processing applications more efficient in the future.

ASPHALION experts Laura Casals, Lourdes Martín and Núria García Pazos, together with other two excellent lecturers will bring you up to date with the electronic submission form on the PLM portal and prepare you for future developments.

The online training course organized by FORUM INSTITUT will cover the following topics:

· Introduction to ISO IDMP and implementation process

· PMS rationale and implementation

· Product Lifecycle Management (PLM) portal

· Effects of IDMP implementation on the regulatory processes

· Introduction to CTIS portal management and main functionalities

Event Info

Search News & Events

NEWS | EMA PMS API Beta Release

June 12, 2026

As announced by the European Medicines Agency (EMA) during the PMS Info Day held on Tuesday, the PMS API Beta Release will be published today,

EVENT | EMA PMS INFO DAY

June 9, 2026

Today, ASPHALION expert Sonia Tejeda is participating in the Product Management Service (PMS) Information Day at the European Medicines Agency premises in Amsterdam, an important

SOLUTIONS | RegOps Systems Readiness

June 4, 2026

Are you facing challenges with regulatory software compliance or preparing for upcoming regulatory changes? At Asphalion, we support organizations with a focused audit and readiness

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

CSR

AI Ethic Code

Careers

FORUM INSTITUT SEMINAR | Updates on EMA Electronic Application Management

The variations submission for human medicines became the first form to be submitted via the PLM portal in November 2022, with other application forms to follow.

Search

Filter by category