Who should attend?
- 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
Why you should attend
- The course is widely accepted by both industry and regulatory agencies
- It is the most cost-effective course of its kind compared with commercial courses
- It has the widest range of international speakers and facilitators, with representatives from industry, contract houses and regulatory agencies compared to similar courses
- You will gain confidence as a regulatory affairs professional
- The opportunity to network with speakers and fellow delegates
Learning outcomes
The regulatory function and the EU environment (see more)
- 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 (see more)
- 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 (see more)
- 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 (see more)
- 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 (see more)
- An understanding of Medical Device Technology
- An understanding of Biotechnology products
- An understanding of Abridged applications including Generics
Past delegates have gone on to become...
- Senior Director, Regulatory Affairs
- Senior Regulatory Executive
- Global Regulatory Affairs Manager
- Regulatory Affairs Consultant
- Regulatory Operations Manager
What is included?
- 5 interactive days with a comprehensive range of topics and case studies
- Extensive reference pack to take away
- 4 nights/ 5 days full board accommodation
- Over 15 hours of networking opportunities
The registration fee includes accommodation for four nights from Monday 14 March and all meals from registration on Monday until the close of the course on Friday. Travel is not included.
BOOKING FOR THIS EVENT IS NOW CLOSED - PLEASE CONTACT MEETINGS@TOPRA.ORG FOR FURTHER INFORMATION ON FUTURE INTRODUCTORY COURSES
Registration fees
Member (includes accommodation and meals): £3,125 + £625.00
Non Member (includes accommodation and meals): £3,580 + £716.00
All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions
- Fee includes accommodation for the nights of 14,15,16,17 March and includes all meals from registration on Monday to the close of the course on Friday. Travel is not included.
- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £150 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.