Autumn Introductory Course 2018

Autumn Introductory Course 2018
A standalone introduction to Pharmaceutical Regulatory Affairs (also Module 0 - 7FHH1097 of the MSc Regulatory Affairs programme).

When
: 6-9 November 2018
Where: Vienna House Andel’s Prague, Stroupeznickeho 21, 15000 Prague, Czech republic



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 update their knowledge 
  • Allied professionals wishing to understand the role of regulatory affairs 

Note: This is course is also Module 0 - 7F441097 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 
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

  • Hans van Bruggen, Senior Regulatory Affairs Scientist at Qdossier/eCTDconsultancy
  • Kora Doorduyn-van der Stoep, Senior Policy Adviser, Medicines Evaluation Board (Netherlands)
  • Matthias Finkler, Regulatory Affairs Expert, Finkler GmbH
  • Steve Harston, Principal at Steve Harston Regulatory Affairs
  • Stefan Hirsch, Novartis Pharma AG
  • Vicky Jones, Director at Sapientia Regulatory Services
  • Birka Lehman, former Head of Executive Department, EU and International Affairs, at Federal Institute for Drugs and Medical Devices (BfArM) – Germany
  • Sandrine Lemaire, GlaxoSmithKline
  • Ann Lenihan, Director of Regulatory Affairs at Pfizer Pharmaceuticals
  • Marjolign van Lier, Regulatory Affairs Scientist at eCTDconsultancy
  • Ian Martin, European Regulatory Affairs Director, AstraZeneca
  • Arthur Merlin d'Estreux, Associate Director, GRA Respiratory and Oncology, Teva Pharmaceuticals
  • Ronald de Meijer, Director of Regulatory Affairs at Astellas Pharma Europe
  • Claire Onody, Global Regulatory Lead, UCB
  • Bimal Patel, Freelance Regulatory Consultant
  • Azzurra Ravizza, Director of Worldwide Regulatory Strategy at Pfizer
  • Ann Scott, Director at OA Regulatory
  • Elizabeth Soames, Nonclinical Regulatory Project Manager at GlaxoSmithKline
  • Lynda Troy, independent regulatory affairs director and former Global Regulatory Lead at AstraZeneca
  • Andrew Willis, Principal at A. Willis Consulting and forma Regulatory Affairs Specialist at Extab Corporation

 

Programme

Download the 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 Prague VAT rate of 21% 
  • The registration fee does not include accommodation 
  • Refreshments, lunch for four days and three evening meals are included in the registration fee
 

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. 

When
06/11/2018 - 09/11/2018
Where
The Autumn Introductory Course PRAGUE CZECH REPUBLIC
Your VAT country
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Our policy on photography and video

On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

However, if for any reason you do not wish TOPRA to use your image or voice please let us know

Recording and photography by delegates is not permitted.