When: 12-15 November 2024
Where: Ramada, Avenida Engenheiro, Arantes e Oliveria 9, Lisbon, Portugal
This course is essential for:
People new to Regulatory Affairs who want to acquire a comprehensive foundation
Regulatory professionals wishing to update their knowledge
Allied professionals wanting to understand the role of Regulatory Affairs
Justin Hayzen (Regulatory Affairs Manager, Porton Biopharma Ltd.) has recently made the switch to working in regulatory affairs after working in a series of technical roles. In the short video below, he explains how he benefitted from attending this training course.
Course information
TOPRA's Introductory Courses have been designed to provide a firm foundation to your career in regulatory affairs. They are the most comprehensive of their kind and are presented by speakers and facilitators from industry and agencies, all respected authorities in their field. Our four-day Overview of EU Pharmaceutical Regulatory Affairs course (formerly known as The Autumn Introductory Course) covers all aspects of the product development process and provides a sound overview of EU legislation and regulatory procedures, plus explores the central role regulatory affairs plays in modern healthcare companies and the development cycle of new drugs.
Note: This course is also Module 0 of the MSc Regulatory Affairs.
Benefits for delegates
CPD: This course provides 30 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
People new to regulatory affairs who want to acquire a strong foundation
Regulatory professionals wishing to broaden or update their knowledge
Allied professionals moving into regulatory affairs
Four interactive days with comprehensive range of topics and case studies
Develop a network to support the rest of your career
Meet and learn from an international speaker panel from agencies, industry and contract houses
High quality course materials
Gain the practical skills to be a highly effective regulatory professional
Industry-wide recognised programme will be an excellent start to your career
Programme
You can view and download the draft agenda here.
Module Leaders
Sacha Lynch, Principal Consultant, DLRC
Grzegorz Kojro, CDM Manager, Pfizer
Presenters
All courses are taught by experts with real-life practical knowledge and experience. Presenters have included experts from Medicines Evaluation Board (MEB), The State Institute for Drug Control (SUKL), Novartis Pharma AG, Sapientia Regulatory Services, GlaxoSmithKline, Gilead, Pfizer Pharmaceuticals, eCTDconsultancy, Teva Pharmaceuticals, Jazz Pharmaceuticals, DLRC and Astellas Pharma Europe.
Hans van Bruggen, Celegence
Pricing
Standard
- Member: £2,775 + VAT*
- Non-member: £3,165 + VAT*
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
Discount prices:
- Those working for regulatory agencies, government agencies or academic institutions:
- Members: £2,081.25 + VAT*
- Non-members: £2,373.75 + VAT*
- Those working for charities, patient groups or in full-time education:
- Members: £1,387.50 + VAT*
- Non-members: £1,582.50 + VAT*
*VAT, if applicable, is charged at the local rate of of 23%.
Hotel
If you wish to book accommodation at the hotel please email kay@topra.org for a booking form.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.