Spring Regulatory Affairs Introductory Course

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 with a clear understanding of:

• European Union Regulatory Institutions and how Medicines Legislation
  is developed
• European routes to obtaining Marketing Authorisations
• Data Requirements for Marketing Authorisation Applications
• Clinical Trial Approval procedures in the European Union
• Maintenance of Marketing Authorisations and Life Cycle Management

The Regulatory Affairs function within the pharmaceutical industry is absolutely pivotal to the successful development and licensing of safe and effective medicines, to the benefi t 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 and promotional activities.

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 50 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 Spring Introductory Course has been running successfully for over 30 years. This experience, combined with the feedback we receive from our presenters and delegates, ensures that the TOPRA Introductory Course is always up-to-date and in tune with the needs of the pharmaceutical industry.

• Most comprehensive course available of its kind
• Over 30 years of experience
• Over 50 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 six days, delegateswill have a unique opportunity tomeet 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?

Delegates should ideally have a minimum of six months professional regulatory experience to gain maximum benefit from the Course. The Course is also suitable for those wishing to refresh their regulatory knowledge and for allied professionals who want to understand drug development and its interface with 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.
The TOPRA Introductory Course combines formal presentations with highly interactive workshops and breakout sessions. At the end of each day (Monday to Thursday) a tailored case study enables delegates to turn the theory into practice. Delegates are encouraged to work within a project team environment and to develop their communication skills. With a high facilitator to delegate ratio, there is always someone available to provide assistance.
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 the evenings there are further opportunities to network, have some fun, or simply relax.

Key Speakers

Course content is delivered by speakers with experience from key EU Regulatory Authorities, Companies and Industry Associations and may include:

• Amgen
• BfArM
• Biogen Idec
• Bristol Myers Squibb
• CHMP
• GlaxoSmithKline
• Johnson & Johnson
• MHRA
• Organon
• PMCPA
• Pfizer

Please note that all programmes covered in this brochure could be subject to changes.

Learning outcomes for TOPRA IC courses

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 and pharmaceutical development and the regulatory requirements
• The importance of Good Manufacturing and 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
• How to be ready for electronic submissions and eCTD
• The importance of Product Information; SmPC’s, labelling and leaflets

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

Post Authorisation Activities

• Aspects of successful life-cycle management
• The requirements and procedures for variations and renewals
• The importance of pharmacovigilance and risk management

Specialist areas

• An understanding of Medical Device Technology
• An understanding of Biotechnology products
• An understanding of Abridged applications including Generics
• Advertising
• Paediatric Development
• The importance of scientific advice

Important course information

Course Timings
The Introductory Course begins with registration on Sunday 25th April from 15.00. The first lecture starts at 16.00 on Sunday and the Course ends with lunch on Friday 30th April at 13.00.

Contact TOPRA
If you have any enquiries, or require more information, please contact the Meetings Coordinator at the TOPRA office. See details below.

TOPRA, Bellerive House, 3 Muirfield Crescent, London E14 9SZ
Tel: +44 (0) 20 7510 2560 Fax: +44 (0)20 7537 2003
E-mail: meetings@topra.org

Venue
Selsdon Park, Addington Road, Sanderstead,
South Croydon, Surrey CR2 8YA, UK
Tel: +44 (0) 20 8657 8811
Fax: +44 (0) 20 8651 6171
Email: claire.ashton@principal-hotels.com
Website: www.principal-hotels.com