The Importance of Regulatory CMC Strategy

Events , News , News & Events
Wednesday 11 January 2023

Accelerate development using a Quality Target Product Profile

Missed our webinar?

Watch the replay

Having the right Chemistry, Manufacturing, and Controls (CMC) documentation throughout drug development is essential for avoiding pitfalls, ensuring an efficient regulatory review process, and achieving the goals for your product. The key is an early development regulatory strategy that includes CMC.

Join our regulatory CMC webinar to strengthen your knowledge of how regulatory CMC strategies can accelerate the drug development process and become familiar with strategic tools such as the Quality Target Product Profile (QTPP).

Agenda

10:00 Start and introduction by Hilde Holme

Product Development by Hilde Holme

Quality Target Product Profile by Marianne Ammitzbøll

CMC Documentation & Roadmap by Hilde Foros and Lone Dyrby

Summary by Lone Dyrby

10:30 Q&A

10:45 End

Speaker bios:

Lone Dyrby,

Regulatory Director, Denmark
Lone.Dyrby[@]linkmedical.eu

Lone has 20 years of experience within Regulatory CMC for biologics from the pharmaceutical industry and from the Danish Medicines Agency. Lone has over 10 years of leadership experience.

Hilde Holme,

Regulatory Director, Norway
Hilde.Holme[@]linkmedical.eu

Hilde has 25 years of experience in the pharmaceutical industry within research, QC, QA, and regulatory affairs, working extensively within all aspects of regulatory CMC worldwide. Hilde has over 15 years of leadership experience

Marianne Ammitzbøll,

Senior Regulatory Manager
Marianne.ammitzboll@linkmedical.eu

Marianne has over 10 years of experience within Regulatory CMC in development and lifecycle projects from various positions in the pharmaceutical industry.

Hilde Foros,

Senior Regulatory Manager
Hilde.foros[@]linkmedical.eu

Hilde has more than 20 years of experience in the pharmaceutical industry within various technical roles and regulatory CMC responsibilities, including both pre-marketing and post-marketing CMC.

Need help now?

Contact us

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-functional	1 year	The GDPR Cookie Consent plugin sets the cookie to record the user consent for the cookies in the category "Functional".
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".
cookielawinfo-checkbox-performance	1 year	Set by the GDPR Cookie Consent plugin, this cookie stores the user consent for cookies in the category "Performance".
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.
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.

Cookie	Duration	Description
li_gc	6 months	Linkedin set this cookie for storing visitor's consent regarding using cookies for non-essential purposes.
lidc	1 day	LinkedIn sets the lidc cookie to facilitate data center selection.
UserMatchHistory	1 month	LinkedIn sets this cookie for LinkedIn Ads ID syncing.
wp-wpml_current_language	session	WordPress multilingual plugin sets this cookie to store the current language/language settings.
yt-player-headers-readable	never	The yt-player-headers-readable cookie is used by YouTube to store user preferences related to video playback and interface, enhancing the user's viewing experience.
yt-remote-cast-available	session	The yt-remote-cast-available cookie is used to store the user's preferences regarding whether casting is available on their YouTube video player.
yt-remote-cast-installed	session	The yt-remote-cast-installed cookie is used to store the user's video player preferences using embedded YouTube video.
yt-remote-fast-check-period	session	The yt-remote-fast-check-period cookie is used by YouTube to store the user's video player preferences for embedded YouTube videos.
yt-remote-session-app	session	The yt-remote-session-app cookie is used by YouTube to store user preferences and information about the interface of the embedded YouTube video player.
yt-remote-session-name	session	The yt-remote-session-name cookie is used by YouTube to store the user's video player preferences using embedded YouTube video.
ytidb::LAST_RESULT_ENTRY_KEY	never	The cookie ytidb::LAST_RESULT_ENTRY_KEY is used by YouTube to store the last search result entry that was clicked by the user. This information is used to improve the user experience by providing more relevant search results in the future.

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.
_gcl_au	3 months	Google Tag Manager sets the cookie to experiment advertisement efficiency of websites using their services.
AnalyticsSyncHistory	1 month	Linkedin set this cookie to store information about the time a sync took place with the lms_analytics cookie.
CONSENT	2 years	YouTube sets this cookie via embedded YouTube videos and registers anonymous statistical data.

Cookie	Duration	Description
bcookie	1 year	LinkedIn sets this cookie from LinkedIn share buttons and ad tags to recognize browser IDs.
bscookie	1 year	LinkedIn sets this cookie to store performed actions on the website.
li_sugr	3 months	LinkedIn sets this cookie to collect user behaviour data to optimise the website and make advertisements on the website more relevant.
VISITOR_INFO1_LIVE	6 months	YouTube sets this cookie to measure bandwidth, determining whether the user gets the new or old player interface.
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.

The Importance of Regulatory CMC Strategy

Accelerate development using a Quality Target Product Profile

Agenda

Speaker bios:

Lone Dyrby,

Hilde Holme,

Marianne Ammitzbøll,

Hilde Foros,

Need help now?

More news

Don't miss out on the latest updates

Get in touch

How can we help you?