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Key Documents in Drug Life Cycle

Categories: Medical writing
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About course

This training is designed to provide an overview of the key documents required during the drug development process.
The learning objectives of this training are:

1) list the key documents in the drug lifecycle,
2) define the key documents and their purpose,
3) categorize the key documents per development phase

What will you learn?

  • Introduction Key Documents in drug life cycle: In the introduction, the journey of a new medicine from the laboratory to the patient is shortly explained and a summarized overview of key documents to be developed during the drug life cycle is given.
  • Key Documents before start of clinical trial: This chapter elaborates on the purpose and content of key documents written before the start of a clinical trial, including the Clinical Development Plan, Clinical Trial Application (EU)/Investigational New Drug (US), Investigator's Brochure, Clinical Study Protocol, Informed Consent Form, Pediatric Investigation Plan (EU)/Pediatric Study Plan (US), and Briefing Document.
  • Key Documents during conduct of clinical trial: This chapter elaborates on the purpose and content of key documents written during the conduct of a clinical trial, including the Development Safety Update Report and Statistical Analysis Plan.
  • Key Documents after completion of clinical trial: This chapter elaborates on the purpose and content of key documents written after the completion of a clinical trial, including the Clinical Study Report, Summary of Results, and Lay Summary of Results.
  • Key Documents to apply for marketing authorization: This chapter elaborates on the purpose and content of key documents written to apply for marketing authorization, including the Clinical Overview and Clinical Summary as part of the Common Technical Document, as well as the Risk Management Plan, Risk Evaluation and Mitigation Strategies, Pharmacovigilance Plan, and Response to Questions.
  • Key Documents during marketing: This chapter elaborates on the purpose and content of key documents written during marketing, including documents for marketing and patient communication and the Periodic Benefit-Risk Evaluation Report.

Course content

Key Documents in drug life cycle
This training is designed to provide an overview of the key documents required during the drug development process.

  • Introduction Key Documents in Drug Life Cycle
    04:13
  • Key Documents before start of Clinical Trial
    11:46
  • Key Documents during conduct of Clinical Trial
    02:35
  • Key Documents after completion of Clinical Trial
    05:29
  • Key Documents to apply for Marketing Authorization
    06:56
  • Key Documents during Marketing
    03:44

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Matthias Franssen
Matthias Franssen
1 month ago
Good training for people involved in writing, reviewing and/or developing clinical trial documents.

A course by

Thary Jacob
Thary Jacob

Currently, I’m a motivated specialist medial writer at Emtex Life Science.

I studied biomedical sciences at the University of Ghent, mastered in immunology and did a PhD at the laboratory for veterinary animal sciences in Merelbeke on alphaherpesviral spread, triggered by interesting research along my path.

While I enjoyed doing this, I wanted to be closer to patients in my career path, which is why I chose to go to the industry. I wanted to be near the end, the patient, the finalized stage - to contribute to telling the story. Medical writer seemed the perfect job for me, and I haven’t had any regrets during the past 8 years that I’m a medical writer at Emtex.

Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.

With over 20 years of experience in the field, we guarantee the best possible medical writing and related services.