European Regulatory Procedures 2017
Course "European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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...
Why should you attend:
• What is EMA and the overall process with CP, MRP, DCP and other interactions with agencies?
• Identify the challenges to global submissions management presented by EU versus US key differences
• Understand the EU legislative environment and the key EU Directives and Regulations relating to human medicines and for strategic regulatory intelligence decision-making
• Identify and address challenges and pain points to the global submissions management process and making critical regulatory decisions based on EU versus US differences
• Demonstrate knowledge on navigating the regulatory process through EMA regulations and inspection guidelines regarding submissions
• Learn more about and how to apply the different types of procedures for authorization
• If "full/usual" authorization not possible, several options exist
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
Who Will Benefit:
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. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the EMA and regulatory process, including:
• Clinical Research Associates
• Clinical Project Managers
• Regulatory Affairs Professionals
• Clinical Investigators and Clinical Research Coordinators
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Consultants
Agenda:
Day 1 Schedule
Lecture 1: EMA and Regulatory Overview and Pathways
• 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
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...
Why should you attend:
• What is EMA and the overall process with CP, MRP, DCP and other interactions with agencies?
• Identify the challenges to global submissions management presented by EU versus US key differences
• Understand the EU legislative environment and the key EU Directives and Regulations relating to human medicines and for strategic regulatory intelligence decision-making
• Identify and address challenges and pain points to the global submissions management process and making critical regulatory decisions based on EU versus US differences
• Demonstrate knowledge on navigating the regulatory process through EMA regulations and inspection guidelines regarding submissions
• Learn more about and how to apply the different types of procedures for authorization
• If "full/usual" authorization not possible, several options exist
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
Who Will Benefit:
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. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the EMA and regulatory process, including:
• Clinical Research Associates
• Clinical Project Managers
• Regulatory Affairs Professionals
• Clinical Investigators and Clinical Research Coordinators
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Consultants
Agenda:
Day 1 Schedule
Lecture 1: EMA and Regulatory Overview and Pathways
• 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
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