9 out of 10 U.S. life sciences attorneys and professionals surveyed – despite their knowledge of FDA law – are not well versed in the essentials of the European regulatory schematic for drugs and biologics.
The Complete Agenda and Speaker Faculty are now available.
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It is no longer enough to rely on European regulatory advisors and counsel. Now is the time to boost your European pharmaceutical regulatory IQ!
ACI has developed this European Pharmaceutical Regulatory Law Boot Camp to give FDA lawyers and U.S. regulatory affairs professionals – as well as other professionals who need to understand the regulatory backdrop of the pharmaceutical industry – a critical working knowledge of core regulatory competencies necessary for working within the established protocols of the EMA and other European regulatory bodies responsible for the regulation of pharmaceutical products.
Get Critical Insights into the European Approval and Post-Approval Processes for Drugs and Biologics. Gain an in-depth understanding of pharmaceutical regulatory protocols in the EU.
A distinguished faculty of top European pharmaceutical regulatory experts will guide you through the complex intricacies of:
- The organization, jurisdiction and function of the EMA and other European regulatory bodies responsible for pharmaceutical regulation
- The impact of Brexit on European pharmaceutical regulation
- The essentials of the three methods of drug approval in the EU
- EU clinical trials protocols and related Directives
- The interplay between the patent and approval processes for drugs and biologics in the EU
- The EU’s approval pathway for biosimilars
- The EU pharmacovigilance system and adverse events monitoring processes
- European cGMP requirements
- Recall standards and guidances
Attend this conference and learn to navigate the European regulatory maze that plays such an essential part in the successful commercialization of pharmaceutical and biological products.
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ACI’s Global Series of Life Sciences conferences bring together key sector stakeholders from around the globe to explore the most important trends impacting the many industries including pharmaceutical, biotechnology, medical device/diagnostics, and FDA-regulated consumer products. Our events cover every facet of legal and business relevance as well as controversy. Learn More