DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies" conference to their offering.
This seminar will provide an overview and in-depth snapshot of the regulatory process with EMA and other regulatory authorities. Individuals desiring a comprehensive overview of the regulatory filing requirements in Europe, including personnel within Regulatory Affairs in the pharmaceutical, biopharmaceutical and generic drug industries, as well as experienced professionals requiring a "refresh" will find this seminar beneficial.
Overview:
- EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.
- In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
- EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation.
- Today, seven EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool of several thousand European scientific experts from the network.
- And Much More...
Areas Covered in the Session:
- EMA and many NCAs are involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP
- The legal basis and main features of the various types of authorizations
- Evaluate the various options for the submission of a marketing authorization application for regulatory strategy for the compound in the EU
- As a bonus, identify the necessary steps needed to prepare for, and survive, an EMA inspection
For more information about this conference visit http://www.researchandmarkets.com/research/wnz796/european
