Updated EU filing and registration procedures (including the new variation rules coming in to force)

Why Should You Attend:

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 and individual European countries. Content will 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 be discussed. Course content will 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.

Learning Objectives:

• 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.

Detailed Agenda of the Session:

• EU Agency Regulatory Structure.
• Registration Options.
• Company Strategy- Linking Clinical Trials & Marketing Authorization Applications.
• Balancing Strategy and Long Term Regulatory Cost & Maintenance.
• 2007 Pediatric Legislation.
• IMP Dossier- EU Expectations and Comparison of CTA to IND Applications.
• Registration Procedures ( Member State Procedures, Mutual Recognition Procedure, Centralized Procedure EMEA).
• 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 and 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
• 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 EMA 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
• Maintaining Your License: Renewals

Who Will Benefit:

This 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. This webinar will be of great value to clinical research professionals and those working with them involved in carrying out clinical trials. It is primarily designed to benefit the following disciplines:

• Clinical research and medical operations
• Researchers managing combined IMP’s/Medical Devices that also deliver Therapeutics (e.g. medicinal coated stents)
• Quality Assurance such as GCP Auditors
• Regulatory affairs
• Clinical trial supply
• Personnel at the study site
• CRO personnel
• All personnel who need to understand the impact of the EU Clinical Trials Directive

Instructor Profile:

Robert J. Russell (Bob), is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.

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