The Autumn Introductory Course

The Autumn Introductory Course
Our annual Autumn Introductory course is a comprehensive 4-day introduction to EU Pharmaceutical Regulatory Affairs (also Module 0 of the MSc Regulatory Affairs programme).





When
: 5-8 November 2019
Where: IntercityHotel Berlin Hauptbahnhof, Katharina-Paulus-Straße 5, 10557 Berlin, Germany
Start time (First day):  08:00
End time (Last day):  16:00 

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 
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 in the past have included 

All courses are taught by experts with real-life practical knowledge and experience. Past presenters have included experts from Medicines Evaluation Board (MEB), Novartis Pharma AG, Sapientia Regulatory Services, Federal Institute for Drugs and Medical Devices (BfArM). GlaxoSmithKline, Pfizer Pharmaceuticals, eCTDconsultancy, AstraZeneca, Teva Pharmaceuticals, Astellas Pharma Europe and The State Institute for Drug Control. 

Programme

Download a copy of the latest course programme    
 

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.

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 Germany VAT rate of 19% 
  • The registration fee does not include accommodation 
  • Refreshments, lunch for four days and three evening meals are included in the registration fee

 
Related courses

Course: Spring Introductory Course
Course: Essentials of European Pharmaceutical Regulatory Affairs 
Online course: Essentials of European Regulatory Affairs
On-demand webinar: Your Career in Regulatory Affairs - Your First Steps

 

Next steps

CRED European Regulatory Procedures | 2019 date to be announced 
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

When
05/11/2019 - 08/11/2019
Where
The Autumn Introductory Course BERLIN GERMANY
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