Advanced Therapy Medicinal Products (ATMP) Development and Manufacturing

Certificate

Course Details

Course Code	SG_SNBMA_S09
Level	9
Duration	1 semester
Credits	5
Method of Delivery	Online
Campus Locations	Sligo
Mode of Delivery	Part Time

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Advanced Therapy Medicinal Products (ATMP) Development and Manufacturing

Apply Now How to Apply

Course Overview

This module aims to equip the learners with a well-rounded understanding of ATMP development and manufacturing. This blended course of 5 days of theory and NIBRT onsite practicals combines theoretical sessions blending comprehensive regulatory knowledge with hands-on technical experience, to ensure it equips the attendees with the skills and insights required to excel in ATMP production and compliance.

The course emphasises regulatory frameworks, quality systems, risk management and cleanroom operations, ensuring learners gain both theoretical and practical expertise.

NIBRT Global Qualification (NGQ)

The NIBRT Global Qualifications (NGQs) are internationally recognised training qualifications setting a new benchmark for biopharmaceutical education and workforce development.

Earn your NGQ by completing a micro-credential accredited by ATU – a short, flexible and accredited way to upskill and advance your biopharma career.

Step 1 – Complete an upstream practical training course at the NIBRT facility or at an affiliated NIBRT Global Partner site.
The upstream practical training module provides students with a fundamental understanding of both the theoretical and practical aspects of cell culture processing as it relates to the manufacture of modern biopharmaceutical products.

Step 2 – Register for the corresponding NGQ below for €500. To earn the qualification, you will complete a multiple-choice quiz, a 2,000-word lab report, and a 1,500-word reflective assessment. Upon successful completion, you will receive your accredited NGQ certificate (5 ECTS). NGQs are stackable, leading to a Special Purpose Award (30 ECTS).

Fee Payment: €500 fee is paid directly to NIBRT via a payment link that will be sent post registration. If you have received a funding subsidy, you will be sent a payment link for the adjusted amount owed.

Course Details

Year 1

Semester	Module Details	Credits	Mandatory / Elective
1	Advanced Therapy Medicinal Products (ATMP) Development and Manufacturing This module aims to equip the learners with a well-rounded understanding of ATMP development and manufacturing. This blended course of 5 days of theory and NIBRT onsite practicals combines theoretical sessions blending comprehensive regulatory knowledge with hands-on technical experience, to ensure it equips the attendees with the skills and insights required to excel in ATMP production and compliance. The course emphasises regulatory frameworks, quality systems, risk management and cleanroom operations, ensuring learners gain both theoretical and practical expertise. Learning Outcomes 1. Critically evaluate and apply ATMP manufacturing principles in compliance with relevant regulatory frameworks, including EU GMP Annex 1, FDA guidelines, and ATMP-specific regulations. 2. Implement GxP principles, draft and evaluate GMP compliant SOPs and conduct risk assessments effectively. 3. Critically apply contamination control strategies and advanced aseptic techniques within cleanroom environments, demonstrating mastery of industry best practices. 4. Assess and implement appropriate QC techniques, including sterility, endotoxin testing, and flow cytometry, to ensure product integrity and regulatory compliance. 5. Troubleshoot issues within manufacturing processes with confidence and develop teamwork, critical thinking, problem-solving and troubleshooting skills in real-world scenarios.	05	Mandatory

Recommended Study Hours per week

3 hours per week

Examination and Assessment

Theory: 30%
Lab Report: 40%
Reflective Report on Learning Applied to own employment (1500 words): 30%

On-Campus Attendance Requirement

For this special purpose award, students are required to attend five days in NIBRT at their state-of-the-art
facilities in Dublin. This represents week one. A time limit of 12 months is applied from NIBRT mandatory
attendance until completion of additional learning online via ATU for the special purpose award. Students can
access this SPA any time in either semester 1 or semester 2 and the results will be brought to the next
available exam board.

Progression

Student could progress by completing another special purpose award or Level 9 major award in a related area

Download a prospectus

Postgraduate Prospectus Online, Flexible & Professional Development Prospectus

Entry Requirements

To be eligible, applicants must have completed the Mandatory Practical attendance for this module with NIBRT within the previous 12 months.

Fees

Total Fees EU: €500

€500 fee is paid directly to NIBRT via a payment link that will be sent post registration. If you have received a funding subsidy, you will be sent a payment link for the adjusted amount owed.

Further information on fees

Careers

Operators, Technical Staff, New hires, Jobseekers, Sales staff and Managers and industry employees wishing to enhance their employment opportunities by increasing their understanding of ATMP development and manufacturing who complete this programme have great employment opportunities based on EGFSN recent report.

A new report from the Expert Group on Future Skills Needs forecasts that 21,000 additional jobs are likely to be created in the Biopharma sector in Ireland by 2027. The report, entitled Skills for Biopharma – Researching and forecasting the current and future skills needs of the Biopharma sector in Ireland to 2027 shows the strong growth in employment in the Biopharma sector in both manufacturing and services subsectors in Ireland since 2016, and highlights the specific skills needed to support this dynamic and strategically important sector for Ireland’s economy. This report highlights that microcredentials for BioPharma training are an opportunity for skills enhancement.