This European regulation Seminar provides a comprehensive overview of EMA and National Requirements and other Agencies. This seminar will provide an in-depth snapshot of the regulatory process with EMA and other regulatory authorities. Individuals who are seeking 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.
“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.
2 day European Regulation Conference 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
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
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 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
Lecture 1: EMA and Agencies
• 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
Lecture 2: Exercise and Recap of Day 2
• Interactive Discussions
• Review of Regulatory Documents
Lecture 3: Debrief/Adjourn
• Recap of topics and key discussion points and take away message
• FAQs and latest trends
Speaker: David R. Dills
Global Regulatory Affairs & Compliance Consultant
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.
Zurich, Switzerland Date: August 28th & 29th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50