When: 17 - 20 November 2020
Where: Online
TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please meetings@topra.org.
Course information
TOPRA's Introductory Courses have been designed to provide a firm foundation to your career in regulatory affairs. It is the most comprehensive of its kind and is presented by speakers and facilitators from industry and agencies, all respected authorities in their field.
Our four-day 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. This course is essential for:
- 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
Note: This course is also Module 0 of the MSc Regulatory Affairs.
Benefits for delegates
- 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
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.
Presenters
All TOPRA courses are taught by experts with real-life practical knowledge and experience. Confirmed speakers for this course include:
- Birka Lehmann - formerly of Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany
- Andrew Willis - A. Willis Consulting, UK
- Elizabeth Soames - DLRC Regulatory Consultancy, UK
- Tomas Radimersky - State Institute for Drug Control (SUKL) Czech Republic
- Azzurra Ravizza - Pfizer, UK
- Arthur Merlin d’Estreux – Jazz Pharmaceuticals, USA
- Pauline Gerritsen - Gerritsen Pharmacovigilance Consulting, France
- Andrew Modley – TEVA
- Stefan Hirsch - Novartis Pharma AG, Switzerland
- Sandrine Lemaire - GlaxoSmithKline, Belgium
- Kora Doorduyn-van der Stoep - Medicines Evaluation Board in The Netherlands, Vice chair of CMDh
- Claire Onody - UCB, UK
- Vicky Abbott - Sapientia Regulatory Services Ltd, UK
- Julia Anne Lenihan - Pfizer, UK
- Ann Scott - O A Regulatory
- Marloes van der Geer - Qdossier, Switzerland
- Hans van Bruggen - Qdossier, Switzerland
- Bimal Patel - Regulatory Affairs Consultant, UK
Suitable for
This course is most useful 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
Programme
Download a copy of the programme here (subject to change)
Pricing
Course fees:
| Type |
Member |
Non-member |
| Standard |
£2,690+VAT |
£3,010+VAT |
Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.
|
Those working for regulatory agencies, government agencies or academic institutions
|
£2,017.50+VAT
|
£2,257.50+VAT
|
Those working for charities, patient groups or are in full-time education
|
£1,345+VAT |
£1,505+VAT |
|
*VAT, if applicable, is charged at the rate of 20%
Next steps
CRED European Regulatory Procedures
CRED Practical Document Writing and Management
7-29 March 2017, UK
Establishing a firm foundation to your career in regulatory affairs is essential from the outset, and TOPRA is dedicated in playing its part in enabling you to become a regulatory professional with our introductory courses.
The spring edition of our popular three-day course will help you to become a more confident and proactive regulatory affairs professional.
Why should you attend?
- Three interactive days with a comprehensive range of topics and case studies
- Networking opportunities with peers and industry professionals
- An international speaker panel from agencies, industry and contract houses
- High quality course materials
- All inclusive meals
Speakers will include highly respected regulatory professionals from across the industry.
Our introductory course is chosen by regulatory affairs managers for their staff as the most comprehensive course of its kind, reflecting the latest developments in European legislation and best practices.
The course has been completely updated in a three-day format that recognises the time and budgetary restraints of the modern regulatory affairs professional.
Past delegates have gone on to become:
What is included?
- 3 interactive days with a comprehensive range of topics and case studies
- Over 8 hours of networking opportunities
Before booking this course, please read the
training terms and conditions.
By booking a place on this course you are agreeing to the
training terms and conditions.
Registration fees:
Member: £2,295 + VAT
Non Member: £2,675 + VAT
- All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions
- Please note the registration fee excludes accommodation. Further details on how to book accommodation will be sent with the detailed confirmation letter.
- Refreshment breaks, lunch for three days and two evening meals are included in the registration fee.
- 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.
27-29 March 2017, UK
Establishing a firm foundation to your career in regulatory affairs is essential from the outset, and TOPRA is dedicated in playing its part in enabling you to become a regulatory professional with our introductory courses.
The spring edition of our popular three-day course will help you to become a more confident and proactive regulatory affairs professional.
Why should you attend?
- Three interactive days with a comprehensive range of topics and case studies
- Networking opportunities with peers and industry professionals
- An international speaker panel from agencies, industry and contract houses
- High quality course materials
- All inclusive meals
Speakers will include highly respected regulatory professionals from across the industry.
Our introductory course is chosen by regulatory affairs managers for their staff as the most comprehensive course of its kind, reflecting the latest developments in European legislation and best practices.
The course has been completely updated in a three-day format that recognises the time and budgetary restraints of the modern regulatory affairs professional.
Past delegates have gone on to become:
What is included?
- 3 interactive days with a comprehensive range of topics and case studies
- Over 8 hours of networking opportunities
Before booking this course, please read the
training terms and conditions.
By booking a place on this course you are agreeing to the
training terms and conditions.
Registration fees:
Member: £2,295 + VAT
Non Member: £2,675 + VAT
- All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions
- Please note the registration fee excludes accommodation. Further details on how to book accommodation will be sent with the detailed confirmation letter.
- Refreshment breaks, lunch for three days and two evening meals are included in the registration fee.
- 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.
Book now
Simply log in or create an account and register below.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions