🔑 𝐄𝐱𝐜𝐢𝐭𝐢𝐧𝐠 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐨𝐥𝐥𝐨𝐰𝐢𝐧𝐠 #𝐑𝐒𝐈𝐃𝐌 2024!
It was invigorating to immerse ourselves in the dynamic discussions at DIA's #RSIDM Forum 2024, held in North Bethesda, Maryland, USA!
This year's event brought together a vibrant community of industry experts, speakers, exhibitors, sponsors, and delegates, fostering invaluable exchanges on the latest trends, innovations, and best practices in #regulatory submissions, information, and document management.
Among the plethora of enlightening presentations, several key takeaways emerged:
👉🏻 𝐄𝐧𝐡𝐚𝐧𝐜𝐢𝐧𝐠 𝐅𝐃𝐀 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲:
With over 270,000 drug applications annually, improving data quality remains paramount for the #FDA. Efforts towards standardization and leveraging technology, such as the upcoming ESG Next Generation aim to streamline processes and enhance user experience.
👉🏻 𝐌𝐨𝐝𝐞𝐫𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐄𝐟𝐟𝐨𝐫𝐭𝐬 𝐚𝐭 𝐂𝐁𝐄𝐑 𝐚𝐧𝐝 𝐂𝐃𝐄𝐑:
Initiatives like accepting #eCTD 4.0 and leveraging #AI underscore CBER's commitment to innovation. Similarly, CDER's focus on reducing technical validation issues through modernized submission processing is commendable.
👉🏻 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞:
Embracing standards like the #RIM Reference Model and open APIs fosters consistent information flow, crucial for achieving operational excellence across regulatory domains.
👉🏻 𝐆𝐥𝐨𝐛𝐚𝐥 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐂𝐨𝐧𝐯𝐞𝐫𝐠𝐞𝐧𝐜𝐞:
Understanding the vision for a global #dossier and convergence of regulatory requirements can significantly reduce review timelines and facilitate collaboration, simplifying complex filing strategies.
👉🏻 𝐃𝐢𝐠𝐢𝐭𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 #𝐀𝐮𝐭𝐨𝐦𝐚𝐭𝐢𝐨𝐧:
Success in digitizing regulatory content operations hinges on adopting software-agnostic content standards. Prioritizing these standards ensures that people and processes remain central to technological advancements.
A heartfelt thank you to DIA for curating this enriching conference. We're already eagerly anticipating next year's event!
#keytakeaways #lifesciences #compliance #IDMP #regulatorycompliance #regulatoryaffairs #pharma #pharmaceuticals #biotech #regulatorydata #ArtificialIntelligence #datagovernance
Matt Tyler, Hans van Bruggen, Michiel Stam and Matthias Sijtstra
C-Suite Executive | Marketing Strategist | Biotech | Regenerative Aesthetics | Women's Health | Beauty | Working Mom Advocate | Investor | Entrepreneur
2moLooking forward to it!