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Overview What You Will Learn Webinar Speakers Who Should Watch?

Watch Now: The Regulatory Landscape in 2025 – What You Need to Know

Pharmaceutical companies today are navigating an increasingly dynamic and complex regulatory environment. As we move through 2025, staying informed about regulatory changes and preparing for what lies ahead is essential for maintaining compliance and accelerating market access.

In this exclusive on-demand webinar, our experts explore key regulatory trends, submission challenges, and global authority expectations that will define the pharmaceutical regulatory landscape. Don’t miss this opportunity to gain strategic insights and practical knowledge from seasoned regulatory affairs experts.

 

Where

Online Webinar

When

March 12, 2025 | 10:00 AM ET

What You Will Learn

  • eCTD 4.0 Update – Hear the latest on eCTD 4.0 implementation and its anticipated benefits for regulatory submission strategy and content structure
  • AI & Automation – Explore practical applications of AI in regulatory planning, document generation, and submission management
  • AI Regulatory Update – See how artificial intelligence is being applied across submission planning, data analytics, and compliance documentation
  • ATMPs 2025 – Get clarity on the regulatory challenges in CMC and how to streamline submissions for Advanced Therapy Medicinal Products (ATMPs).

Webinar Speakers

speaker-profile

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.

speaker-profile

Product Owner, Celegence

Kosta Uzelac

With over 12 years of experience in pharma IT, Kosta leads product development at Celegence. His expertise spans RIMS, submissions, publishing, and document management systems, with a strong focus on translating regulatory needs into agile, high-impact software solutions for the life sciences industry.

Who Should Watch?

  • Regulatory Affairs Professionals preparing for 2025 submissions
  • Quality Assurance teams focused on compliance and documentation
  • Global Regulatory Strategy Leads and Project Managers
  • Pharma companies seeking to align with upcoming regulatory expectations

Stay Ahead of 2025 Regulatory Shifts!

Gain the insights you need to proactively adapt your global regulatory strategy. Watch the webinar now and equip your team for regulatory success in 2025.

Authored By

Shilpam Rajput

More by Shilpam Rajput