Autumn Regulatory Affairs Introductory Course

TARGET THE HEART OF EUROPEAN REGULATORY AFFAIRS

Carefully researched and updated each year by practising Regulatory Affairs Professionals. Attend this course and return to your office a more confident Regulatory Affairs Professional.

Learning outcomes

• The Regulatory Function and the EU Environment
  • The role and importance of the Regulatory Affairs function and how it fits into the product development process
  • The EU regulatory environment, the organisations involved and how legislation is developed.
  • Future developments in the pharmaceutical industry
  • The importance of regulatory strategy
  • Successful interaction with authorities
• The Marketing Authorisation Application, Science, Content and Structure
• The fundamentals of chemical-pharmaceutical development and the regulatory requirements
• The importance of Good Manufacturing Practice and Good Clinical Practice
• The need for pharmacology, pharmacokinetic and toxicology data
• Clinical development and the conduct of clinical trials
• The content and structure of marketing authorisation applications in the common technical document format
• The importance of Product Information; SmPC’s, labelling and leaflets
• How to be ready for electronic submissions and eCTD
• EU Regulatory Procedures
• The theory and practical reality of the Centralised procedure
• The theory and practical reality of the decentralised and mutual recognition procedures
• How to choose and use the procedures
• The importance of scientific advice
• Post Authorisation Activities
• Aspects of a successful life-cycle management
• The requirements and procedures for variations and renewals
• The importance of pharmacovigilance and risk management
• Specialist core areas
• An understanding of Medical Device Technology
• An understanding of Biotechnology products
• An understanding of Abridged applications including Generics

The Regulatory Affairs function within the pharmaceutical industry is absolutely pivotal to the successful development and licensing of safe and effective medicines, to the benefit of patients’ health worldwide.

• Chosen by Regulatory Affairs Managers who wish to get their people up-to-speed on current EU regulatory practices
• Looks at the bigger picture, focusing not only on EU legislation and regulatory procedures, but also on the central role that Regulatory Affairs plays in a modern pharmaceutical company and in the development of new drugs from early non-clinical investigations, through human clinical trials, via manufacturing, testing and supply, to post-approval maintenance.

Key features of the course

• A winning combination of lectures and interactive case studies that afford you the opportunity to put theory into practice
• An international speaker panel with representatives from industry, contract houses and regulatory agencies
• Residential course providing plenty of time for exchanging knowledge and sharing experiences with fellow students and speakers

Overview

The Course is presented by over 30 speakers and facilitators, all respected authorities in their fields. No other course of its kind enables delegates to interact with so many leading regulatory professionals.
The Autumn Introductory Course has been running successfully for 16 years. This experience, combined with the feedback we receive from our presenters and delegates, ensures that the TOPRA Introductory Course is always up-todate and in tune with the needs of the pharmaceutical industry.

• Most comprehensive course available of its kind
• 16 years of experience
• Over 30 speakers and facilitators
• Detailed course notes
• Industry and Regulatory Agency specialists
• European perspective

Why attend?

The Course is widely accepted by both Industry and Regulatory Agencies as the most comprehensive of its kind. The Course provides new Regulatory Affairs professionals with a good understanding of the different functions involved in the product development process and their inter-dependencies. In addition, a good legislative overview will be gained, with case studies providing delegates with practical experience of working in a project team on a variety of regulatory challenges.
Over the five days, delegates will have a unique opportunity to meet their peers, network with leading Industry and Regulatory Agency specialists from Europe and experience working in a team-based environment.

• Develop their understanding of drug development and the role of Regulatory Affairs
• Gain confidence as a Regulatory Affairs professional
• See the bigger picture
• Become more proactive
• Experience working in project teams
• Interact with Regulatory Agency and Industry leaders
• Network with colleagues

Who should attend?

This residential course is essential for anyone starting a career in Regulatory Affairs whether they are new to the pharmaceutical industry or moving from other areas within the pharmaceutical field. This course is also suitable for more experienced regulatory professionals who wish to update their knowledge of European Regulatory Affairs.

• People new to Regulatory Affairs who want to acquire a comprehensive foundation
• Regulatory Professionals wishing to update their knowledge
• Allied Professionals wishing to understand the role of Regulatory Affairs

Course structure

The objectives of each part of the course are achieved by use of lectures, interaction with the lecturers and case studies. Each programme day includes a case study. These accurately tailored case studies enable delegates to turn theory into practice. In small teams you will be able to focus on subjects such as chemical-pharmaceutical development, clinical trial authorisations, choice of regulatory procedure and variations. In addition, facilitators are available to assist.
Each session is fully documented with copies of all slides so that delegates can focus on the presentations. The course notes provide an up-to-date overview of current trends in Regulatory Affairs as well as being useful reference material for future use.
In order to promote networking, the course includes welcome cocktails on the Monday evening and two further enjoyable social events. The social events are included in the course fee and include transport where applicable.

Programme

Please download our course brochure for a full course programme.