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About

This course provides grounding in the principles of Good Manufacturing Practice, specifically related to the manufacture of Investigational Medicinal Products (Annex 13). Applying GMP to IMPs provides assurance that the results of clinical trials are not compromised by inadequate safety, quality, or efficacy arising from unsatisfactory manufacture of the product. It has many other benefits, including ensuring that results are comparable across different batches of Investigational Medicinal Products. For the process to work, personnel must have adequate training in requirements specific to Investigational Medicinal Products.

This course is designed for those working with IMPs in clinical trials, offering an interactive and visually appealing format. It provides valuable insights into GMP applications based on the author’s professional experience and allows participants to earn three CPD points.

Course Syllabus

  1. Definition of an IMP
  2. How does Annex 13 affect me?
  3. Why do we need Annex 13 when we already have GMP?
  4. Application of Annex 13

  1. The Sponsor
  2. The Manufacturer and Packager
  3. The Qualified Person
  4. Shipping
  5. Receipt of the IMP at the clinical trial site (Step 1 – Check the packaging)
  6. Receipt of the IMP at the clinical trial site (Step 2 – Check the labelling)
  7. Receipt of the IMP at the clinical trial site (Step 3 – Check the study or trial number)
  8. Receipt of the IMP at the clinical trial site (Step 4 – Check the expiry/use-by date)
  9. Receipt of the IMP at the clinical trial site (Step 5 – Check the patient ID and dosage)
  10. Receipt of the IMP at the clinical trial site (Step 6 – Check the storage conditions)
  11. Receipt of the IMP at the clinical trial site (Step 7 – Check the batch certification, temperature, and humidity results)
  12. Receipt of the IMP at the clinical trial site (Step 8 – Quarantine if not assured)
  13. Storage of the IMP
  14. Dispensing
  15. Handling the subject in a clinical trial
  16. End of the study

  1. Handling Complaints
  2. Recalls

  1. Final Conclusion

Course Benefits

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Fully compliant

This course follows the guidance of Annex 13 of the European Commission's GMP guidelines

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Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.

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Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.

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Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.

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Reliable and trustworthy

This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...