Date: 23 October 2023
Duration: 3 days
Location: Brussels, Belgium
Cost: £ 1799 - £ 2899
Organiser: Informa Connect
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.