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

CMC Documents: Scientific Writing for Regulatory Submission
17-10-2017

Our seminar will provide you with practical tools to help you become more comfortable writing the CTD's CMC documents.

After a short update on grammar, English standards and style, you will be better equipped to write Module 3 and the Quality Overall Summary: you will be able to present data clearly and in compliance with the regulations, and you will be able to sew a "golden thread" through your CMC documents.

In addition, English writing skills will be a part of your repertoire, enabling you to deal with the difficulties posed by the English language to both native and non-native speakers. Having applied your writing skills to practical exercises, you will be able to write the drug substance as well as the drug product sections using sophisticated English.

Last but not least you will learn to crosscheck the CMC documents prior to submission and to avoid questions from Health Authorities.

17 October 2017 in Koln