The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Mar. 21 & 22, 2007
Who Should AttendThis course will be of benefit to regulatory personnel whose responsibilities require knowledge of the EU and European country regulatory environment. Administrative staff responsible for ensuring compliance with regulatory filings will also find this training highly relevant. Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit. Learning Objectives This course is designed to provide an overview of the regulatory environment throughout Europe and will provide training in: • How the EU and individual countries within Europe interact
• Which registration procedure to use
• How regulations effect product development strategies
• Pricing issues – Coordinated filing vs. Individual filing
• Understanding the concerns/issues of European Regulatory Personnel
• How to negotiate with the regulators
• Information necessary for effective submissions
• Strategies for streamlining the registration application process for faster approval
• The advantages and disadvantages of various registration procedures Course Description This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in the EU, as well as, individual European countries. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations. The current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing techniques. Common issues which have caused difficulties for pharmaceutical firms will also be discussed. Course content will also explain how the EU interacts with national regulatory agencies and how personnel can best address the conflicts that sometimes arise. This course will also be useful for sales or general management personnel who need an overview of the registration process within the EU. ________________________________________ COURSE AGENDA DAY ONE Registration Procedure(s) • Member State Procedures
• Mutual Recognition Procedure
• Centralized Procedure Abridged Applications • Similar Products & Devices
• Non-t “Similar” Products & Devices
• Request for Extensions
• Use of Expert Reports Variations • Changes Concerning Manufacturing Aspects (Product & Process)
• Labeling & Packaging Leaflet Requirements
• EU Commission Regulations
• Mutual Recognition Procedure
• Centralized Procedure Decision Making Process • Scope
• Check-in Procedure
• Internal Commission
• Consultation
• Industry’s Ability to Impact
- Involvement & Timing
• Standing Committee Participation
• Favorable Standing Committee Opinion
• Non-Favorable Opinion
- Process & Timing
DAY TWO
Review of Regulatory Authorities
• International, Regional, and Local laws applicable for each European Union Nation Member State analysis of applicable regulations at all levels with practical examples of how the regulations are applied • Legislative Process
• Objectives of the Rules Governing Medicinal Procedures
• Regulatory Framework
• New Products, Requirements, & Procedures Political implications of the regulations • Compare/Contrast EMEA and the FDA procedures How and When to Influence the Regulatory Process • Effective Monitoring Activity
• Association vs. Individual Company Involvement & Intervention
• The Regulatory Negotiation Process
• Effective Approaches
• The Do’s and Don’ts of Regulatory Involvement How to use regulations/regulatory contacts to your advantage • Check-in Procedure
• Internal Commission Interactions
• Procedures within each regulatory office, contacts, etc.
- Product Development Strategy
• Business Impact Within and Outside the EU
• Professionalism in Regulatory Lobbying Changes to Marketed Products Case Study – A review of the filing/registration procedure
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