Overview of EU Pharmaceutical Regulatory Affairs

Overview of EU Pharmaceutical Regulatory Affairs
Module 0 of the MSc: This course covers all aspects of the product development process, and provides a sound overview of EU legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.

When: 12-15 November 2024
Where: Ramada Wyndham Hotel, Avenida  Engelheiro, 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



    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


    Andrew Modley, Teva



    Kora Doorduyn-van der Stoep    , MEB



    Vicky Abbott    , Sapienta Regulatory Services Ltd



    Jan Ohotski    , Medpace



    Elizabeth Soames,     ProPharma Group


    Esther Nougier, Boehringer Ingelheim

     

    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.
    When
    12/11/2024 - 15/11/2024
    Where
    Ramada Avenida Engenheiro Arantes E Oliveira Numero 9 LISBON PORTUGAL
    Registration is closed.
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    Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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