What is the IMPD and why is it so relevant early in the drug development process? What to consider? What do professional medical writers do and how do you get support from them?
The Investigational Medicinal Product Dossier (IMPD) is a central piece of documents required for approval of clinical trial applications by the regulatory authorities in the EU. The IMPD contributes to the overall success of drug development programs, and, for a first-in-human clinical trial, it is the initial document to assemble all obtained research data.
In this Online Educational Forum Lecture "Critical Facts about Writing an Investigational Medicinal Product Dossier (IMPD) for Successful Clinical Trial Applications", Dr. Carola Krause, President of the European Medical Writers Association (EMWA), and Abraham F. Shevack, past-President of the EMWA, will tell us about what to consider when preparing an IMPD for clinical trial applications and how you get support from professional medical writers.
- After the online lecture, you will have insight into:
- What is the Investigational Medicinal Product Dossier (IMPD) and why is it so relevant for successful clinical trial applications in the EU?
- Why should you start with the IMPD early in the drug development process?
- What are the timelines?
- What is a professional medical writer doing?
- How does the European Medical Writers Association (EMWA) support scientists?
Carola, based in Potsdam Germany, is a workshop leader on IMPD writing and currently serves as the President of the EMWA. She has been offering a professional biomedical writing consultancy service to the pharmaceutical industry since 2016. Her multidisciplinary background in academic and pharmaceutical project management, and clinical trial coordination provides her with key insights into all phases of the drug development process and its regulatory requirements. Carola serves the European Commission as external HORIZON EUROPE and EUROSTARS expert.
Abe Shevack, based in Berlin Germany, is past-President of the EMWA (2017-2018), workshop leader, and Chair of EMWA Ambassador’s Programme. He is a Biologist with over 15 years in basic research in molecular biology in both academia and industry. Abe has been a Senior Scientific medical writer for over 20 years with Schering and Bayer, preparing documents for global regulatory submissions in the EU, Asia Pacific region, and the USA. Since 2016, Abe is a freelance Medical Writer and consultant with clients in Pharma and Biotech.
Online via Microsoft Teams ǀ Please register here!
Please note that you will receive the Microsoft Teams link the evening before the lecture and that access to last minute registrations, cannot be guaranteed.
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