The Regulatory Landscape in 2025: What you need to know

When: May 7, 2025 | 10:00 AM ET
Where: Online Webinar
How to Register: Sign up here

As innovations, such as data exchange, AI integration, and product complexity evolve, regulatory expectations continue to shift. Keeping up with these changes is essential for pharmaceutical organizations.

Join Celegence on May 7, 2025, for a webinar with industry expert Maurice Bancsi, who will discuss the most significant trends and challenges shaping the regulatory space. This session will provide a clear overview of upcoming developments and will set the scene for Celengence’s deeper, strategy-focused webinars throughout the rest of the year.

• Publishing & Submission Trends: Hear the latest on eCTD 4.0 implementation and its anticipated benefits, as well as how ICH M4Q and FDA KASA are influencing submission strategy and content structure.
• Regulatory Data Management: Explore how FHIR is facilitating more efficient data exchange and how ontologies are enabling better standardization and integration of regulatory information.
• Cell & Gene Therapy Regulation: Get clarity on the regulatory challenges in CMC and how to streamline submissions for Advanced Therapy Medicinal Products (ATMPs).
• AI in Regulatory Operations: See how artificial intelligence is being applied across submission planning, data analytics, and compliance documentation.
• Platform Technologies: Learn about regulatory approaches to emerging technologies that span multiple therapeutic areas or product types.

This session is ideal for professionals across pharmaceutical R&D, Manufacturing, and Regulatory Affairs – including:

• Regulatory Affairs and CMC professionals preparing for submission changes
• R&D and manufacturing leaders seeking to understand cross-functional compliance trends
• Decision-makers looking to adopt forward-thinking strategies in regulatory operations

• Maurice Bancsi, Principal SME & Head RA, Celegence
  With more than 28 years of global regulatory experience, Maurice leads pharmaceutical regulatory strategy at Celegence. His expertise spans oncology, pulmonary, and cardiovascular indications, with deep involvement in pre-approval drugs, regulatory intelligence, and major submission types such as MAAs, INDs, CTAs, and Orphan Drug Applications.

Whether you’re planning your 2025 regulatory roadmap or supporting upcoming submissions, this session offers essential insights to align your strategies with Health Authority priorities.

All registrants will receive a recording of the webinar post-event.

Stay current, stay compliant – join us on May 7th.