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Navigate the European Pharmaceutical Regulatory Maze

ACI's European Pharmaceutical Regulatory Boot Camp | March 26, 2020

ACI's European Pharmaceutical Regulatory Law Boot Camp is designed to provide you with critical knowledge of core competencies of pharma regulation in Europe.

NEW YORK CITY, NEW YORK, UNITED STATES, February 13, 2020 / -- Did you know that 9 out of 10 U.S. regulatory 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?

Yes, it’s true --- and dangerous as we live in a time when most biopharmaceutical companies are multinational. This information is critical to advance not only your products, but your career.

In light of this startling statistic, ACI has developed our inaugural Boot Camp on European Pharmaceutical Regulatory Law. This conference has been designed to provide you with a critical working knowledge of core competencies of pharmaceutical regulation in Europe.

A distinguished faculty of top European pharmaceutical regulatory experts will share their knowledge and 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 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

- Comparative effectiveness and therapeutic evaluation studies

- 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.

Seats at this event are sure to go quickly.

Register today!

Andrea Sachs
American Conference Institute
+1 212-352-3220
email us here