Introductory Courses
If you want to build a solid and comprehensive foundation in regulatory affairs, our Introductory Courses are for you.
These popular courses have been established for 35 years and are presented by over 50 speakers and facilitators from industry and agencies, all respected authorities in their fields.
Each five-day residential course covers all aspects of the product development process and provides a sound overview of EU legislation and regulatory procedures. We look at the central role regulatory affairs plays in a modern pharmaceutical company and the development cycle of new drugs.
Autumn Introductory Course
3-7 November 2013
Leonardo Royal Hotel, Berlin, Germany
Medical Devices Introductory Course
3-5 June 2013
TOPRA offices, London, UK
Who are the courses for?
- People new to regulatory affairs
- Professionals wishing to update and refresh their knowledge
- Allied professionals wishing to understand the role of regulatory affairs.
We suggest that you have at least six months’ regulatory experience before attending these courses.
Why should I attend?
The TOPRA Introductory Courses are recognised as the most comprehensive of their kind. The content for each course is up to date and researched by practising regulatory professionals.
The intensive, five-day residential course provides a unique opportunity to exchange knowledge and experiences with your peers and build a personal network. You will also have access to international experts from industry and regulatory authorities.
You can expect to gain in confidence as a regulatory professional. The course proves your commitment to regulatory affairs and demonstrates that you have the foundation knowledge to progress your career.
This course has been supplied to UK delegates seeking employment via Job Centre Plus, part of the Department for Work and Pensions.
What will I learn?
The courses look at the big picture, covering not only EU legislation and regulatory procedures but also the central role regulatory affairs plays in a modern pharmaceutical company and developing drugs: from early non-clinical investigations, through human clinical trials, manufacturing, testing and supply, to post-approval maintenance and promotional activities.
For a more information on the course content, see the learning outcomes
How will I learn?
Lectures are given by experts from the regulatory industry, contract houses and EU regulatory agencies. The formal presentations are combined with interactive workshops and breakout sessions.
At the end of each day we turn theory into practice by looking at a tailored case study, tackling realistic regulatory challenges. You will work in a team and develop your communication skills.
With a high facilitator-to-delegate ratio, there is always someone available to answer questions.
Participant feedback
Over 34 years more than 1500 people have completed the courses. Here are just a few of their comments:
'Highly recommended! I now feel I have an excellent overview of ALL aspects of Regulatory Affairs. It was a great opportunity to hear lectures/talks on topics presented by highly respected key leaders in the area and to interact with all levels of Regulatory Affairs Professionals.'
'Fantastic – the quality of speakers has been outstanding. I have learned so much and have thoroughly enjoyed the course.'
'Presentations were extremely good and helpful. This course totally met all expectations and provided just the right information needed as an introduction to Regulatory Affairs.'
'This training will be my core reference to all my future regulatory activities in the EU.'
'I am new to healthcare and this course has given me a complete overview of the whole industry and its regulations.'