FDA’s quality system requirements and EU CTR

With new regulatory developments in the EU and the US, impacting pharmaceutical products as well as medical devices, it is becoming increasingly challenging for industry to stay abreast of change. Conferences, webinars, articles, blogs, and other forums are invaluable ways to gain those key insights. Read the March PharmaLex newsletter to learn more.??

FDA takes steps to harmonize medical device quality system requirements?

The Food and Drug Administration has issued a final rule amending the medical device cGMP requirements of its Quality System regulation to align more closely with other regulatory authorities. The agency is amending 21 CFR part 80 by incorporating by reference the quality management system requirements of ISO 13485. While the ISO requirements are largely similar to the requirements of the QS regulation there are changes that industry will need to observe. Learn more about what the changes mean for industry.?

What transparency rule updates mean for the CTR?

Since the Clinical Trial Regulation (CTR) became applicable at the end of January 2022, there has been extensive guidance and other information issued by various official sources. Among the more recent developments is an update to the transparency rules, which removes some of the unnecessarily complexity from the previous rules. However, staying on top of all the relevant new information can be a challenge for companies conducting clinical trials in the EU or transitioning clinical trials authorized under the Clinical Trial Directive (CTD). Learn more about the new transparency rules and what these mean for industry.?

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Webinar: Exploring productivity gains from a digital transformation journey?

Building standardized digital workflows has been shown to improve productivity and reduce development timelines. In a recent webinar, experts draw on a Sanofi case study to discuss the successes and pain points of a digital transformation journey in process development. Listen to the webinar with Sanofi’s global head of data sciences, CMC, Christian Airiau and Cencora PharmaLex’s statistics and informatics experts, Pierre Lebrun and Arne Balzer.?

Join PharmaLex at DIA to explore industry innovations?

One of the most important events on the industry calendar, DIA Europe 2024, brings together thought leaders from across the life sciences to discuss cutting-edge developments. Representatives from Cencora PharmaLex will join colleagues across the industry during the 3-day conference, held in Brussels from 12-14 March. Visit us at Booth C2 where our team members will be happy to explore industry trends and developments with you.??

Understanding EU requirements for promoting pharmaceutical products?

Promotional compliance in the EU is a highly complex area for pharmaceutical companies. For companies headquartered in the US, these differences can present significant hurdles. The DIA Advertising & Promotion Regulatory Affairs Conference in Arlington, Virginia, which is held from 12-13 March, will delve into this complex field. Join Audrey Athlani Jorno, Cencora PharmaLex’s? promotional materials and compliance expert, to better understand what is required and the importance of planning EU launch campaigns.?