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European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies
Aug 28, 2017 - 09:00 AM - Aug 29, 06:00 PM
Link to Website
Hilton Zurich AirportHohenbühlstrasse 10, 8152 Opfikon, Switzerland,
Phone: 1 929 900 1853
Day 1 Schedule
Introductions and Background
Legal Basis for the European Regulation of Medicinal Products
EU Pharmaceutical Legislation Overview
Review of the key EU Directives and Regulations
Legal and Regulatory basis of marketing authorization applications
Main features of the EU Marketing Authorization (MA) process and next steps
How the EMA, EU institutions and individual national health authorities interact
Identify and describe the scope, operation and management of the Centralized Procedure (CP) and other aspects of the CP
Mutual Recognition (MRP) and Decentralized Procedure (DCP) and factors directly influencing the choice of procedure and your regulatory pathway
MRP is based on the mutual recognition by CMSs of a national MA granted by a RMS
DCP is available for new products which have not yet been authorized in any EEA country and do not fall within the mandatory scope of the CP
Review and navigation of key EU regulatory websites
European Commission (EC), EMA and interrelationship with European Directorate for the Quality of Medicines (EDQM)
National Competent Authorities and interactions with other regulatory bodies
Regulatory Pathways to consider regarding the Centralized Procedure
Prepare and handle effective Consultations with EMA and your pre-submission activities
Managing your procedural phases up to acceptance of the final CHMP opinion and preparing for next steps in the regulatory process
Review of Regulatory Documents
Day 2 Schedule
Reviewing and addressing Decentralized and Mutual Recognition Procedures
Main features and attributes as well as differences of DCP and MRP
Addressing Variations to the EU Marketing Authorization and Post-Approval Changes
Overview and vital elements of the variations procedure and dealing with implementing guidelines and other materials
EU Regulatory Innovations for Specific Groups of Products and having a viable regulatory pathway for Orphan Drugs, Herbal Medicinal products and others
Developing trends and the short and long-term impact on the EU pharmaceutical registration process
Accelerated Assessments and Conditional Approvals and other Considerations
Review of Regulatory Documents
FAQs and latest trends
David R. Dills
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