FORUM INSTITUT- DDC Products: Taking hurdles efficiently

ASPHALION expert Dr Dominique Monferrer, together with other four excellent lecturers will share their in-depth knowledge with you and will address the new regulatory framework for drug-device combination products, the impact they will have on our products and how to implement the requirements.

ASPHALION expert Dr Dominique Monferrer, together with other four excellent lecturers will share their in-depth knowledge with you and will address the new regulatory framework for drug-device combination products, the impact they will have on our products and how to implement the requirements.

October 15, 2021

| Drugs, Medical Devices

📆 9- 10 November, 2021

💻 Online course

The online training course will cover the following topics:

· Current and future regulatory framework

· Submission and quality requirements

· Article 117 MDR and its impact on drug-device combination (DDCs) products

· Clinical considerations and vigilance obligations

· Digital health and DDCs in the light of the new MDR

AIMS AND OBJECTIVES:

The regulatory requirements in the drug and medical-device sector pose numerous challenges to your products. Especially the Article 117 MDR and the draft guideline on quality requirements for DDCs will impact the industry regarding regulatory and quality-related issues, among others.

Search News & Events

NEWS | High-risk medical devices pilot

April 17, 2024

EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices.

NEWS | New Insight on the Implementation of MDR Article 17

April 12, 2024

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

The European Union’s AI Act & its Impact on Medical Devices

April 2, 2024

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

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

FORUM INSTITUT- DDC Products: Taking hurdles efficiently

ASPHALION expert Dr Dominique Monferrer, together with other four excellent lecturers will share their in-depth knowledge with you and will address the new regulatory framework for drug-device combination products, the impact they will have on our products and how to implement the requirements.

Search

Filter by category

Related news and events

NEWS | High-risk medical devices pilot

NEWS | New Insight on the Implementation of MDR Article 17

The European Union’s AI Act & its Impact on Medical Devices

FORUM INSTITUT- DDC Products: Taking hurdles efficiently

ASPHALION expert Dr Dominique Monferrer, together with other four excellent lecturers will share their in-depth knowledge with you and will address the new regulatory framework for drug-device combination products, the impact they will have on our products and how to implement the requirements.

Search

Filter by category

Related news and events

NEWS | High-risk medical devices pilot

NEWS | New Insight on the Implementation of MDR Article 17

The European Union’s AI Act & its Impact on Medical Devices

Schedule a Free Meeting