Taking Advantage of the EU MDR Delay in Uncertain Times – Webinar
Overview
Where
Online
When
10:00 AM ET
Helping you prepare for 2025’s regulatory developments
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 experts Maurice Bancsi and Kosta Uzelac, 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.
Who Should Attend?
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
What You Will Learn
What You Will Learn
- 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.
Webinar Speakers
Principal SME & Head RA, Celegence
Maurice Bancsi
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.
Product Owner
Kosta Uzelac
With over 12 years of experience in pharma IT, Kosta leads product development at Celegence. His expertise spans RIMS, submissions, publishing, and DMS systems, with a strong focus on translating regulatory needs into agile, high-impact software solutions for the life sciences industry.
Gain a Competitive Advantage – Register Today
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.
For more information on how Celegence can help improve your regulatory compliance, reach out to us at info@celegence.com, contact us online or read more about Celegence’s services.
Authored By
Celegence Admin
Where
Online
When
10:00 AM ET
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25 Apr, 2025
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