Sheraton Brussels Airport, Brussels,
Hybrid Event
Ensure Adherence to Regulatory Requirements and Bolster Pharmaceutical Compliance with Comprehensive Updates on IDMP, RIM, Global E-Submissions, Legislation and Global Markets
Unlock the blueprints to successfully structure your common technical document guided by direct feedback from the EMA, Competent Authorities and seasoned industry experts
2024 Agenda Line-Up
As a hybrid event, attendees will have the option to attend either in-person or digitally:
In-Person attendees: Join your peers in Brussels with access to all in-person sessions in tracks 1 & 2 plus live stream access to the digital only Global Markets sessions from the Summit in Brussels.
Digital attendees: Join your peers virtually for the Global Markets track. Interested in other sessions? Access all of the session recordings from the in-person Summit in Brussels post-event.
UNLOCK CUTTING-EDGE REGULATORY UPDATES AND EXCEL TOWARDS REGULATORY COMPLIANCE
Brand New for 2023: Regulatory Guidance and Legislative Landscape
· Align your regulatory operations and affairs teams
· Hear the latest on the EU Commission’s Pharmaceutical Strategy for Europe
· Dive into the Revision of the EU General Pharmaceuticals Legislation
· Successfully implement the new Clinical Trials Regulation (CTR)
Regulatory Information Management and Data Initiatives
· Take a closer look at the EMA’s Agile Transformation
· Receive working Group Updates including UNICOM, CTADHL, & ICH MQ4
· Disucss the latest Data Initiative Case Studies including DADI, PQ/CMC, CTIS, PLM, & G-SRS
Exclusively Virtual Track: Regulatory Affairs in Global Markets
· Get to grips with convergence and reliance across all emerging markets
· Tune into the The current status of ICH adoption globally
· Hear the latest eLabelling initiatives in global markets
· Keep up-to-date with Biosimilar regulations in LATAM, APAC and EMEA
Global eSubmissions: What's Next for eCTD 4.0?
· Current status of eCTD implementation across Europe and industry’s current experiences
· eCTD regional updates including Brazil, China and EAEU
· Unpick the the intersection of eCTD and IDMP
· Essential updates from projects including Accumulus Synergy and Orbis
Are You Interested in Sharing Your Expertise at GPRAS 2024?
CONNECT WITH KEY BUYERS AT GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT 2024
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact Hanieh Ahmadian: HAhmadian@informaconnectls.com