Global Pharmaceutical Regulatory Affairs Summit

Conference Details

Date: 23 October 2023

Time: 08:00

Duration: 3 days

Location: Brussels, Belgium

Cost: £ 1799 - £ 2899

Organiser: Informa Connect

Conference Website

Conference Description

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.