Admission requirements
Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report and Oral presentation. Only available to students of the Industrial Pharmacy specialisation. The course Good Manufacturing Practice (GMP) for Middle Management has to be completed.
Description
This two-day training provides insight into the regulatory requirements for drug development from both the viewpoint of regulatory authorities as well as inspection bodies. Following the journey of product development from drug discovery to non-clinical and clinical studies, the course touches upon the Registration Dossier and will discuss the GLP, GCP and GMP requirements and guidelines. Understanding regulatory expectations will ensure professionals minimize delays and clarify the decisions made along the way.
After having followed this course, you will be able to:
To enhance knowledge of regulatory requirements and best practices for the development of a pharmaceutical product and its quality to be able to comprehend the regulatory landscape and apply that knowledge to ensure product quality, patient safety and compliance with standards.
To create an understanding of concepts and principles in pharmaceutical development to understand the risks, manage and mitigate them in the different stages of development.
To be able to apply tools and strategies for the development and testing of a product.
A basic understanding of the clinical and non-clinical studies to understand their impact on product development, the risks and to manage and mitigate them in relation to product quality.
To be able to assess the right and relevant information about the product to be able to release it for its use in a non-clinical or clinical study.
Course objectives
Awareness of the difference between the GxPs and regulatory expectations.
Understanding of your role in the drug product development.
Knowledge on how to identify gaps in the data package to be submitted for regulatory approval.
Timetable
This course will take place on 3 & 4 June 2025.
Mode of instruction
Lectures, self-tuition, discussion.
Assessment method
This course will be concluded by a written exam and an assignment. Each counting for 50% of the final grade.
For each individual exam, the grade is expressed by using a decimal integer between 1.0 and 10.0 that should be ≥ 5.5. The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0. The final grade should be 5.5 to successfully complete this course.
Reading list
Required reading:
We expect you to have read the following guidelines, in order to understand and follow the
content of the lectures and workshops.
EU GMP Directives
➢ Commission Directive (EU) 2017/1572 supplementing Directive 2001/83/EC of the
European Parliament and of the Council as regards the principles and guidelines of
good manufacturing practice for medicinal products for human use.
o https://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32017L1572&rid=7
➢ Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
o https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536
➢ EU-GMP EudraLex Vol. 4, Part I - Chapters 1 - 9, Annex 13
o https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume4_en
➢ Detailed Commission guidelines on good manufacturing practice for investigational
medicinal products for human use, pursuant to the second subparagraph of Article
63(1) of Regulation (EU) No 536/2014
o https://health.ec.europa.eu/document/download/a0b206a0-5788-406b-9e20-
e0525b16e712_en?filename=guideline_adopted_1_en_act_part1_v3.pdf
Organisation for Economic Co-operation and Development (OECD)
➢ OECD Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
o https://one.oecd.org/document/env/mc/chem(98)17/en/pdf
International Council of Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH)
➢ ICH Q2 Analytical Validation
o https://database.ich.org/sites/default/files/ICH_Q2-
R2_Document_Step2_Guideline_2022_0324.pdf
➢ ICH Q7 Good Manufacturing Practice (GMP)
o https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
➢ ICH Q8(R2) Pharmaceutical development
o https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf
➢ ICH Q14 (2b) Analytical Procedure Development
o https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guidelineq14-analytical-procedure-development-step-2b_en.pdf
Suggested reading:
We suggest you to read the headlines of (or at least look over) the following guidelines.
Knowing these (exist) could be useful during the course.
➢ ICH Q6A(R2) Specifications Drug Substance
o https://database.ich.org/sites/default/files/Q6A%20Guideline.pdf
o https://database.ich.org/sites/default/files/Q6A%20Decision%20Tree.pdf
➢ ICH Q9 Quality Risk Management
o https://www.ema.europa.eu/en/documents/scientificguideline/international-conference-harmonisation-technicalrequirements-registration-pharmaceuticals-human-use_en-3.pdf
➢ ICH M3(R2) Nonclinical development
o https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf
➢ ICH E6(R2) Good Clinical Practice (GCP)
o https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Registration
Enrollment via MyStudymap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).
Contact
Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen, studyadvisorBPS@lacdr.leidenuniv.nl.
Remarks
This course is only available for students of the Industrial Pharmacy specialisation.
This information is without prejudice. Alterations can be made for next year.