Certificate in Quality and Regulatory Practice in the Pharmaceutical Industry

This course comprises one module from the MSc in Pharmaceutical Business Management.

On successful completion of this module, the learner will be able to:

• Critique the processes involved in bringing drugs from the development stage through to market as registered pharmaceutical medicines.
• Critically analyse the concepts of quality and quality assurance in the development, manufacture, and supply of medicines.
• Evaluate the importance and impact of quality systems in the manufacture and supply of medicines.
• Critically assess the role and activities of different regulatory bodies and the necessity for such control in the development, manufacture, and supply of medicines.
• Relate the impact and consequences of poor quality, deviations, complaints and recalls on the organisation, and describe approaches to address and prevent them.
• Critically assess the latest trends in quality systems, management, process control, medicines and regulation.

This course runs online

Wednesday evenings from 6 pm-8.30 pm for ten weeks:

February: 14th, 21st, 28th
March: 6th, 13th, 20th, 27th
April: 3rd, 10th, 17th 

There is a weekend assignment session delivered on campus –Date TBC

Entry Requirements

 Candidates seeking access to the Certfiicate in Quality and Regulatory Practice programme are required to hold either:

1. A Level 8 Honours Degree, 2.2H or higher, in Pharmacy, Science, Business or equivalent discipline.
    
2. A level 8 Honours Degree, 2.2H or Higher, in a non-business related discipline, with the following conditions:
   - ​​Candidates with significant business/management experience may apply through our APEL route, in line with college policy.
   - Candidates who have no management experience  will be assessed as to their prior learning. Where appropriate, candidates will be directed to take an additional module during semester one: Finance for Non-Financial Managers.
    
3. A level 8 Honours Degree, 2.2H or higher, in a business related non-STEM discipline, with the following conditions:
   - Candidates with significant pharmaceutical experience may apply through our APEL route, in line with college policy.
   - Candidates who have no pharmaceutical experience but who hold a business-related degree will be assessed as to their prior learning. Where appropriate, candidates will be directed to take an additional module during semester one: Introduction to Pharmaceutical Industry. This module is intended to prepare learners from general business backgrounds for the pharmaceutical learning outcomes during this MSc programme.

Applicants over the age of 23 may apply on the basis of previous work experience and a demonstration of commitment to further studies (Applicants under the age of 23 are required to meet the minimum entry requirements). 

Each candidate’s application will be considered individually in accordance with the College’s QQI approved quality assurance procedures.

Candidates holding relevant alternative qualifications and those with related experiential learning will be considered under the College’s RPL policy.

English Language

All learners are also expected to be proficient in the use of the English language. Where a candidate’s mother tongue is not English, he/she will be required to provide proof of proficiency in the English language through satisfactory performance on an internationally recognised test (e.g. TOEFL 575, IELTS 6.5 or other similar English language qualifications).

Griffith College is accepting the online Duolingo English Test (DET) as valid proof of English proficiency. Please see here for further details.

How to Apply

Students who wish to apply for this course may apply directly to Griffith College. They should have obtained a degree at least a level 8 honours degree in pharmacy, science, business or related discipline.

When our Admissions team receive your application they will be in contact with you directly.

Please note that not all study modes may be offered at all times; for confirmation, refer to the Intake dates on the Overview tab.

Flexible payment options

Students wishing to pay their fees monthly may avail of our direct debit scheme. Please view our Fees information page for more information and assistance.

Sponsorship

Is your company paying for your course?

They will need to complete a Griffith College Sponsorship Form and send this to the Student Fees Office:

Cork

• Post: Student Fees, Griffith College, Wellington Road, Cork

• Email: [email protected]

2% Learner Protection Charge

All QQI accredited programmes of education and training of 3 months or longer duration are covered by arrangements under section 65 (4) of the Qualifications and Quality Assurance (Education and Training) Act 2012 whereby, in the event of the provider ceasing to provide the programme for any reason, enrolled learners may transfer to a similar programme at another provider, or, in the event that this is not practicable, the fees most recently paid will be refunded.

QQI Award Fee

Please note that a QQI Award Fee applies in the final year of all QQI courses. To find the relevant fee for your course level, please see the Fees page.

Students who complete this course may proceed onto another Pharmaceutical Business Management course at Griffith College, including

• MSc in Pharmaceutical Business Management
• Postgraduate Diploma in Pharmaceutical Business Management

The skillset needed to work in a modern biopharma plant is evolving with the growing importance of biologics products.  

These skills are highlighted in Ireland’s National Skills Strategy 2025, where regulatory compliance and pharma co-vigilance roles are in demand by the industry. 

Progression from this programme could include (depending on prior experience): 

• Clinical - Regulatory Associate 
• CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate 
• Regulatory Affairs Specialist