Upcoming events / Executive Training
  • September

    19

    2017

    Marketing Authorisation Outside the ICH Region

  • September

    20

    2017

    PharmaFORUM Webcast International

  • September

    25

    2017

    Masterclass EU QPPV

  • September

    28

    2017

    Regulatory Leaders FORUM

  • September

    28

    2017

    HTA Assessment in Germany, Spain, the UK and the EU

  • October

    09

    2017

    Pharmacovigilance Inspection Readiness

  • October

    17

    2017

    Advanced Pharmacovigilance Writing and Management

  • October

    17

    2017

    CMC Documents: Scientific Writing for Regulatory Submission

  • October

    24

    2017

    Marketing Authorisation in ASIA

  • October

    25

    2017

    Getting Biosimilars on the US Market

  • October

    26

    2017

    PV Requirements in Emerging Markets

  • November

    21

    2017

    Marketing Authorisation for Human Medicines in Latin America

  • November

    22

    2017

    Off-Label Use in Europe

  • November

    27

    2017

    EU Regulatory Affairs Introductory Training Course

  • November

    29

    2017

    Scientific Writing: Abstracts and Posters

  • December

    06

    2017

    The EU Regulatory Affairs Expert

  • December

    07

    2017

    Set up of a Global PV Quality & Compliance System

  • January

    23

    2018

    Toxicology Winter School

EU Regulatory Affairs Introductory Training Course
27-11-2017

This introductory training course will inform you about all the important obligations and challenges in regulatory affairs. You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory life cycle management for a product and the structure and submission of an electronic dossier.

Learning outcomes:

  • Knowledge of the regulatory affairs procedures in Europe.
  • Knowledge of the requirements and deadlines for each procedure.
  • The ability to choose the most suitable procedure for your product.
  • The ability to contribute to the submission process.
  • Familiarity with the peculiarities of generics.
  • Proficiency in compiling the necessary documents.
  • Knowledge of the structure and content of the SmPC and the package leaflet.
  • Understanding of the principles of electronic submission.
  • Knowledge of the requirements for regulatory life cycle management.